A study protocol for the randomized clinical trial SAFIR FAMILY TALK: a selective primary preventive intervention vs. service as usual for children of parents with mental illness.

doi:10.21203/rs.3.rs-2263026/v1

Download PDF

Research Article

A study protocol for the randomized clinical trial SAFIR FAMILY TALK: a selective primary preventive intervention vs. service as usual for children of parents with mental illness.

https://doi.org/10.21203/rs.3.rs-2263026/v1

This work is licensed under a CC BY 4.0 License

Journal Publication

published 22 Apr, 2023

Read the published version in Trials →

You are reading this latest preprint version

Background

Children of parents with mental illness have an increased risk of developing mental illness themselves throughout the lifespan. This is due to genetic factors but also environmental disadvantages during childhood associated with parental mental illness. Selective primary preventive interventions for the children are recommended to mitigate risk-factors and strengthening protective factors, but large-scale, longitudinal studies are needed. This study aims to investigate the effect of the Family Talk Preventive Intervention in a cohort of children and their parents with mental illness.

Methods

The study is a randomized clinical trial with 286 planned families with at least one parent with any mental illness and at least one child age 7 to 17 years. It will be carried out in the mental healthcare system in the Capital Region of Denmark. Families will be referred from hospitals and municipalities. The children and parents will be assessed at baseline and then randomized and allocated to either the Family Talk Preventive Intervention or service as usual. The intervention group will be assigned to Family Talk Preventive Intervention, a manualized program consisting of ~ seven sessions for the family, including psychoeducation about parental mental illness and resilience in children, stimulating dialogue between family members and creating a common family narrative. The study period for both groups will be 12 months. Follow-up assessments will be conducted after 4 months and 12 months. The primary outcomes are the children’s level of functioning, parental sense of competence and family functioning.

Discussion

Given the prevalence of transgenerational transmission of mental illness, a systematic approach to prevention is needed in the mental healthcare setting. This study provides valuable knowledge on the Family Talk Preventive Intervention with a large sample size, inclusion of any parental mental illness, and examination of the primary outcomes.

Children of parents with mental illness

prevention

parental mental illness

Family Talk Preventive Intervention

transgenerational transmission.

This protocol was written in accordance with the Standard Protocol Items: Recommendations for clinical Interventional Studies (SPIRIT) guidelines (Chan et al., 2013). Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers.

Trial registration {2a} {2b}	ClinicalTrials.gov. Unique Protocol identifier: NCT05615324 Date of registration: 26-10-2022
Protocol version {3}	3.0
Funding {4}	Trygfonden; ID: 127849 Tværspuljen; ID: P-2021-1-13
Author names {5a}	Signe S. Nielsen ¹ Lisbeth J. Mikkelsen¹ Nikolaj Quaade¹ Tracy R. G. Gladstone² William R. Beardslee³ Katrina Bonnemose¹ Nicole K. Rosenberg⁴ Carsten Hjorthøj^1,5 Anne A. E. Thorup^6,7 Merete Nordentoft^1,6 Anne Ranning^1,8.
Author affiliations {5a}	1: Mental Health Center Copenhagen, Research Unit (CORE), Capitol Region (DK). 2: Wellesley Centers for Women, Massachusetts, (USA). 3: Boston’s Children’s Hospital, (USA). 4: Mental Health Centre Copenhagen, Copenhagen (DK). 5: University of Copenhagen, Department of Public Health (DK). 6: Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen (DK) 7: Child and Adolescent Mental Health Center, Capital Region of Denmark (DK) 8: University of Copenhagen, Department of Psychology (DK).
Author roles {5a}	SN and LJM are shared first authors. AR is the Chief Investigator; she conceived the study, led the proposal and protocol development. AT, MN and NR contributed to study design and to development of the proposal. CH was the lead trial methodologist. SN, NQ, AR, KB and LJM drafted the manuscript. All authors read and approved the final manuscript.
Name and contact information for the trial sponsor {5b}	Trygfonden: Hummeltoftevej 49, 2830 Virum. (DK) Phone number +45 45 26 08 26 Sektion for Tværsektoriel Forskning: Nordre Fasanvej 57, 2000 Frederiksberg. (DK) Julie Grew Phone +45 2628 5755
Role of sponsor {5c}	The sponsors were not involved in the design of the trial, in writing the manuscript, or in the decision to submit the manuscript for publication. They will not be involved in the collection, management, analysis, or interpretation of the data.
Roles and responsibilities: committees {5d}	Responsibilities of Trial Steering Committee: AR, NR, CH, MN, AT and WB review progress of study and necessary changes to the protocol to facilitate the smooth running of the study. Responsibilities of Trial Management Committee: AR, LJM, SN and NR are responsible for recruitment and management of participants in the clinical setting. Budget administration and contractual issues with individual centres.

An estimated two in five children grow up with a parent affected by mental illness (Christesen et al., 2021; Maybery et al., 2009). Children born to parents with severe mental illnesses like schizophrenia, bipolar disorder and major depressive disorder have an increased expectancy of developing a psychiatric disorder compared to the background population. By young adulthood more than half have developed unspecific psychiatric disorders, and a third will have a severe mental illness (Rasic et al., 2014). Also during the child and adolescent years familial high risk offspring show early signs of developmental disorders, anxiety, stress or adjustment disorders (Ellersgaard et al., 2018), and the risk of developing a psychiatric disorder is increased by a factor 2–4 compared to children of parents without a mental illness (Thorup et al., 2018).

Family Talk Preventive Intervention

The idea of preventive intervention is not new, in fact, Family Talk was invented by William Beardslee and colleagues in the 1980s. In families affected by parental depression, the intervention has exhibited sustained improved effect after 4.5 years on parental child-related behaviors and attitudes, child-reported understanding of parental disorder and family functioning (Beardslee et al., 2007) and a reduction in internalizing symptoms in the children of parents with mood disorders (Solantaus et al., 2010). Only one study has investigated Family Talk for families affected by parental mental illness of other diagnostic categories than mood disorders, including psychosis, bipolar- and personality disorder, and reported high satisfaction with the intervention by both children and parents (Pihkala et al., 2010), thus supporting the assumption that Family Talk is safe and feasible in transdiagnostic psychiatric populations.

The intergenerational transmission of mental illness from parents to children may take place through a complex interplay of genetics, neurobiological risk factors (van Santvoort et al., 2015), as well as a range of psychosocial factors. The latter may either be directly associated with the parents’ behavior, cognitions and emotions, or may emerge through a myriad of familial and contextual stressors associated with parental mental illness. Indeed, studies have shown higher incidence of factors such as family disruption, single-parent headed households and parental un-employment (Ranning et al., 2016), stigma and isolation (Brockington et al., 2011), all influencing parental resources. Intrinsic factors in the child may also predispose them to be more or less affected by parental mental illness, including temperament, gender, and cognitive and social skills (Reupert et al., 2013). They are less likely to graduate from primary school or achieve high grades (Ranning et al., 2018), have a higher cumulative morbidity and mortality rate (Ranning et al., 2019), and are to some extent overlooked by both the mental health services and social services of the municipality (Ranning et al., 2020).

Preventive and supportive interventions are widely recommended, and a recent review in Lancet Psychiatry presented a mental health prevention strategy identifying children of parents with mental illness as a population, who, owing to their increased risk for mental illness alone, acquire selective primary preventive intervention to shift expected trajectories towards mental illness (Arango et al., 2018). In recent years, Mental Health Services around the world have had an increased focus on development and evaluation of selective prevention initiatives. In Chile (de Angel et al., 2016) and Greece (Giannakopoulos et al., 2021), for example, randomized clinical trials are piloted for families with parental depression, following the original intent of the Family Talk Preventive Intervention. In Germany (Wiegand-Grefe et al., 2021) and the Republic of Ireland (Furlong et al., 2021) researchers are expanding the method to include parents with a range of psychiatric diagnoses.

Explanation for choice of comparator {6b}

Service as usual was chosen as a comparator to investigate the potential benefits of introducing a more comprehensive intervention like Family Talk into the secondary mental health sector as opposed to only one or two sessions of psychoeducation. The latter is standard care according to clinical guidelines in the mental health sector, but the extent to which this is being offered to and accepted by patients are uncertain. Some patients may also be involved in services under Child Protection Services. Information on the families’ use of all relevant services focusing on parenting roles in relation to mental illness and their children are documented for both arms.

Objectives {7}

The main objective of this trial is to compare the Family Talk Preventive Intervention to service as usual for families with a parent(s) with any mental illness. Our primary outcomes are:

The child’s level of functioning

The parent’s sense of competence

Family functioning

We hypothesize that the Family Talk Preventive Intervention is superior to service as usual in improvement of both the child and the parents’ wellbeing at the end of the intervention and after 12 months.

Trial design {8}

The design of the trial is a two-armed, parallel, randomized trial testing for superiority of the Family Talk group versus service as usual. The groups are allocated in a ratio of 1:1.

Study settings {9}

Participants are recruited from different psychiatric centers in the Capital Region of Denmark, together with their family members, from both inpatient and outpatient sites. In addition, families may be referred to the trial from Child Protection Services if inclusion criteria are met.

Eligibility criteria {10}

Eligibility criteria for trial participants

Families are eligible if at least one parent meets the following criteria:

Parent(s) must have at least one ICD-10 (WHO, 2016) psychiatric diagnosis by a psychiatrist, and

at least one point of contact with the secondary mental health system within the previous 2 years before the assessment day, and

have at least one child between the ages of 7 and 17 at day of assessment.

Exclusion criteria exclude participants who do not speak Danish or English.

Eligibility criteria for trial interventionists

The intervention will be performed by mental health care professionals specifically trained in the Family Talk Preventive Intervention (nurses, psychologists, social workers etc.). Training includes 100 hours of instruction delivered over the course of four months, during which each clinician will conduct an intervention of their own with a family and receive supervision from an international expert in the Family Talk method. A written assignment on the intervention concludes the training period and will be evaluated by the expert for the clinician to be certified in the Family Talk method.

Intervention description {11a}

Service as usual (comparison group)

Service as usual is what would normally be offered to eligible families when the SAFIR trial is not running: According to the clinical guidelines of the Mental Health Services in the Capital Region of Denmark, all patients who are parents are to be offered a next of kin conversation, preferably at the beginning of their course of treatment. This is a conversation with the patient, their child(ren) and a mental health professional focusing on the parent’s mental illness and the child’s wellbeing. A preparatory session with the patient (and sometimes co-parent or other adult family member) precedes a session including both parent(s) and children. This session is informative in nature; the professional explains mental illness to the children, facilitates conversation between parents and children, and may refer the family to other services such as support groups for children. If deemed necessary, a notification is sent to Child Protection Services who will then evaluate the need for further, statutory intervention for the child and family. The Mental Health Services train key workers to conduct next of kin conversations using a ten-day course that includes educational background knowledge about the needs of children of parents with mental illness as well as training in how to lead conversations with the families. There is a large variation in the level of awareness for patients’ children between different clinical units in the Mental Health Center, Capital Region and the prevalence of next of kin conversations being offered. The service as usual arm of the study contains no intervention from this study group.

The intervention

Families in the experimental intervention condition will be offered approximately 7 sessions of the SAFIR Family Talk Preventive intervention. See Fig. 1. This is a clinician facilitated, psychoeducational preventive intervention that includes on average 7 sessions designed to improve family communication and understanding of parental mental illness, improve interpersonal relationships, and promote child resilience and utilization of social support (Beardslee et al., 1997). An important tool throughout the intervention is the logbook which the clinician uses for taking notes with each family. The logbook prescribes the planned topics to be covered in each session and the contents of the sessions are noted in the logbook by the clinicians. Two modifications have been made to the original method. First, SAFIR Family Talk includes parents with any mental illness not only depression; and second, in the rare cases where the parent is incapacitated by mental illness and thus unable to participate in the intervention, the other parent and children are invited to participate.

Description of core modules

Module 1 and 2: cover the parent’s history of mental illness, both parents’ view on how the child has been affected by the illness, and both parents’ view on the child’s daily life in the family-, school- and extracurricular domains. Any worries about the child(ren) are discussed. The unique and positively defining quality of the family is identified and verbalized, and the parents voice their desired goal of participating in the intervention. In module 3 (one meeting per child): the clinician sees each child in the family individually and covers the child’s wellbeing and daily life in the family-, school- and extracurricular domains, any recurring conflicts in the family and any concerns about the parent’s illness. Module 4: Is a planning session with the parents, during which the parents receive feedback from the child meetings, and where a family meeting (Module 5) agenda is developed. Session 5: During this session, guided by the clinician, the parents put the mental illness into words and address any problem within the family. Furthermore, the clinician also helps the children to put forward any possible concern or issue. Two follow-up sessions conclude the intervention. Session 6: is a follow up session after 1 month where the parents, together with the clinician, can talk about how they experienced they family session and the possible impact on the family dynamic. Session 7: takes place after a few months with the family discussing the intervention, the future for the family and whether further help is needed. The Family Talk Preventive Intervention lasts 6 weeks to 2 months, and each session has a duration of 60 minutes on average (also see Fig. 1).

Criteria for discontinuing or modifying allocated interventions {11b}

Family Talk is a flexible intervention regarding the number of sessions offered per family. If the clinician deems it necessary, an extra follow-up session or planning session with the parents is possible. Also, the clinician can call for a meeting with the family and social services, teachers or health personnel if further help or support is needed. The service as usual arm of the study contains no intervention from the study group.

Strategies to improve adherence to interventions {11c}

During the intervention every session completed is documented by the clinician according to the contents of the logbook using REDCap electronic data capture tools (Harris et al., 2009). Sessions are either recorded on audio or video. For each clinician two randomly selected sessions will be rated, on a yearly basis, by an independent expert regarding fidelity, i.e., compliance with the specific components of the sessions as prescribed in the logbook and manual. The expert will also evaluate the competency of the clinician based on the intervention provided in the sessions, including generic psychotherapeutic factors. The expert will provide feedback on fidelity to each clinician based on the evaluations. In addition, all clinicians will have comprehensive experience with psychotherapeutic treatment, and most will have had previous experience with children of parents with psychiatric disorders. The clinicians performing the intervention will receive continuous supervision from a family therapist, who is certified in the Family Talk Intervention. In cases of possible mental health problems in the children the clinicians will consult a child and adolescent psychiatrist who is affiliated with the project. The service as usual arm of the study contains no intervention from the study group.

Relevant concomitant care and interventions permitted during the trial {11d}

The participants in the study are permitted to participate in other interventions during the time of the interventions such as services within Child Protection Services and peer groups for children of parents with mental illness. Most patients will receive concomitant individual psychotherapeutic treatment during the time of interventions.

Outcomes {12}

The complete test battery concerning the child, parents and family is listed in table 1. The assessments are supervised by a peer group including a clinical professor in child and adolescent psychiatry and psychologists.

Primary outcomes

Change in the Children’s Global Assessment Scale (CGAS) (Shaffer et al., 1983) from baseline to 4- and 12 months after baseline is the primary outcome measure concerning the child’s level of functioning. The CGAS is a scale from 1 to 100 (higher scores indicate better functioning), which is included in the diagnostic interview Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime (K-SADS-PL) (Kaufman et al., 1997). It concerns the child’s daily level of functioning in the family, in school, and during leisure time. The CGAS has been shown to have high validity and acceptable interrater reliability. It is a dimensional and detailed measurement that accommodates the finding that a given diagnosis can have a very different impact on the functioning of different children. Thus, the CGAS is an ideal tool for capturing any changes the child may experience. CGAS will be measured at baseline, at the end of the intervention, and 12 months after baseline, where both the primary caregiver and the child are interviewed. The CGAS score will be rated by blinded assessors with experience in child and adolescent mental health services, and with training and experience in the use of CGAS.

Change in the Family Assessment Device (FAD) (Miller et al., 1985) (Parent-rated) from baseline to 4- and 12 months after baseline is the primary outcome measure concerning family functioning. The FAD is a thorough questionnaire with 60 items based on a comprehensive sociological theory about the different functions of a family: Family problem solving, communication, roles, affective responsiveness and involvement, behavior control and general functioning. The FAD allows for a comprehensive picture of family functioning in multiple areas and through repeated assessments it can provide an insight to whether family members experience improvement in the well-functioning of their family unit. Each item is scored on a 4-point scale according to the extent of which it describes the family. The FAD is completed by the parents at baseline, 4 months, and 12 months after baseline and measures each individual’s perception of his or her family.

Change in the Parental Sense of Competence (PSOC) t from baseline to 4- and 12 months after baseline is the primary outcome measure concerning parents’ overall experiences of competence in their parenting role (Gibaud-Wallston, 1977). The PSOC is a 16-item self-reporting questionnaire measuring parental competence on two dimensions: Parental satisfaction and parental self-efficacy. The efficacy factor examines the parents’ competence, capability levels, and problem-solving abilities in their parental role, whereas the satisfaction factor examines the parents’ anxiety, motivation, and frustration. The PSOC scale was selected as it is a frequently used tool in assessing parenting self-evaluations and has substantial strengths including good content validity. Through repeated assessments the PSOC can provide an insight to whether the parents in the SAFIR Family Talk group feel supported in their parenting skills. Each parent completes the PSOC thinking only of their youngest child of age 7–17 (i.e., the child selected for assessments). Each item is scored on a 6-point Likert scale ranging from 1 (strongly agree) to 6 (strongly disagree). The PSOC is completed by the parents at baseline, 4 months, and 12 months after baseline.

Secondary outcomes

Secondary outcome measures include change in Beck’s Youth Inventories (BYI-II) (Thastum et al., 2009): A 99 item self-report questionnaire assessing symptoms of depression, anxiety, anger, disruptive behavior, and self-concept, completed by the child at baseline, 4 months, and 12 months after baseline. Each item is rated along a 4-point Likert scale (“never”, “sometimes”, “often” or “always”) and higher scores are associated with negative affect. Also included is change in the Parent-Child Communication questionnaire (Child-rated): A 10 item questionnaire for children of ages 8–12 and 19 items for children aged 13–17 assessing communication between the child and the mentally ill parent. Each item is rated on a 6-point Likert scale, in which a higher score indicates better communication. The Parent-Child Communication questionnaire is completed by the child at baseline, 4 months, and 12 months after baseline. Another secondary outcome measure is change in the Response to Parents’ Mood questionnaire assessing the child’s reaction to the parents’ mood. Furthermore, a secondary outcome measure is change in the Brief INSPIRE-O (Williams et al., 2015): A 5 item self-report questionnaire completed by the parents assessing personal recovery. Each item is rated on a score from 0-100, where a higher score indicates better recovery.

Explorative outcomes

Exploratory outcome measures include change in the Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997), the Kidsscreen-27 questionnaire (Ravens-Sieberer et al., 2007), the Child and Youth Resilience Measurement (CYRM) (Jefferies et al., 2018), the Guilt and Shame Questionnaire (GSQ-AMPI) (Bosch et al., 2020), the Personal and Social Performance Scale (PSP) (Rabinowitz et al., 2021), the Global Assessment of Functioning (GAF-S) (Pedersen & Karterud, 2012), the Parent-Child communication questionnaire (Parent-rated), the Family Talk Evaluation Questionnaire, the Working Alliance Inventory (WAI-SR) (Munder et al., 2010), the Client Satisfaction Questionnaire (CSQ-8) (Attkisson & Zwick, 1982) and the Negative Effects Questionnaire (NeQ) (Rozental et al., 2019), number of days the child was absent from school (information will be obtained from registry and parents’ report), the Family Assessment Device (FAD) (Miller et al., 1985) (children self-report) and the Children of Parents with Mental Illness Questionnaire (COPMI-Q).Table 1:

Participant timeline {13}

Assessment at baseline includes an interview and a battery of questionnaires for both the referred parent with mental illness (called index parent), the other parent and the youngest child in the family between the ages of 7 and 17. After assessment, each family is allocated to either Family Talk or service as usual. Follow-up assessments are conducted at 4 months and 12 months after baseline (See Fig. 2).

Sample size {14}

The primary outcome for the children is the change in the estimate of the child’s general functioning. If the intervention results in an increase of the CGAS-score of five points compared to service as usual (e.g., from 65 to 70, SD = 13), power calculations show that by including 143 children in each group we will be able to measure a difference of 5 points on the CGAS score between the two groups with a power of 0.90. Allocation is 1:1 resulting in n = 286.

Power calculations for the primary outcome of parenting sense of competence (PSOC) are based on the mean of the total scale for mothers in a normative population, which is 60.92 with a standard deviation of 8.94 (Gilmore & Cuskelly, 2009). For a mean difference of 5 points, a power of 0.90 and an error 1 rate of 0.05, a total of 134 participants must be enrolled.

The primary outcome concerning family functioning is the Family Assessment Device (FAD). The mean of general functioning in a normal population is 1.79, with a standard deviation of 0.42(AK et al., 2015). The cut-off value for familial dissatisfaction is 2.00 (Miller et al., 1985). A power calculation with a power of 0.90 and an error 1 rate of 0.05 results in a total of 168 participants.

Recruitment {15}

Families are primarily recruited from all Mental Health Centers in the Capital Region of Denmark, though all eligible families, whether they are self-referred or via the municipality, are invited to participate. Patients meeting the inclusion criteria are asked by clinicians if a researcher from SAFIR could contact them. If the family consists of people other than the legal parents, they are invited to participate in the assessment and intervention as well. From December 2021 individuals matching the criteria for the parent with a mental illness are identified through the Danish, population-based registers and receive an invitation by electronic mail. An estimated 5% of invited individuals reply to invitations.

Assignment of interventions: Allocation

Sequence generation {16a}

Families who provide written informed consent are randomly allocated to either Family Talk or service as usual. Randomisation will be stratified by site using REDCap software. REDCap is an electronic data capture tool hosted at CIMT in the Capital Region of Denmark. The randomisation programme is set up by CH. When the baseline assessment is completed, their contact information is sent to the allocation team that will assign the participants to either intervention or service as usual. The allocation is randomized and computer-generated. The randomisation cannot be influenced by the person making it or any other person.

Concealment mechanism {16b}

Personnel who are not blind to the treatment arm are responsible for the randomisation process. When a family has been recruited for the study and baseline assessment has been conducted, the assessor informs the person responsible for conducting the randomisation process via e-mail.

Randomisation is centralised and computerised with a concealed randomisation. Block size will be unknown to the researchers and clinicians. The randomised intervention allocation is concealed until the statistical analyses of the resulting data have been completed and conclusions have been drawn.

Implementation {16c}

Randomisation is carried out by a member of the research team at the Copenhagen Research Center for Mental Health (CORE) who generates the allocation sequence and assigns participants to interventions.

Blinding {17a}

Outcome assessors, data analysts, and researchers will be blinded throughout the study, including during the statistical analysis. Due to the nature of the intervention, participants and therapists performing the Family Talk Intervention are not blinded.

Procedure for unblinding if needed {17b}

The families are instructed in advance not to reveal allocation to researchers at 4- and 12-months follow-up assessments. If unblinding occurs, it will be registered and another assessor, blind to treatment allocation, will perform the outcome assessment at the follow-up.

Data collection, management, and analysis

Data collection method {18a}

The families are assessed with a range of interviews and questionnaires at baseline, at 4 months follow-up and at 12 months follow-up (see test battery, table 2). The baseline assessment takes approximately 3 hours to complete, and each follow-up assessment takes approximately 2,5 hours. To ensure quality of the data, the assessors are trained in administering both the Personal and Social Performance scale (PSP) (Morosini et al., 2000), the General assessment of function – Symptoms (GAF-S) (Pedersen & Karterud, 2012), the Children’s Global Assessment Scale (CGAS) (Shaffer et al., 1983) and each of the different questionnaires. Both the PSP, the GAF-S and the CGAS ratings are made as consensus.

Plans to promote participant retention and complete follow-up {18b}

The participating families will be contacted by telephone before planned follow-up interviews. If preferred by the families, the next follow-up is often planned in combination with the current. Assessors are flexible and can rearrange the scheduled time if needed. Patients who are in an unstable condition can be assessed at home and both the 4- or 12-months follow-up with the parent can be conducted by telephone to make it more manageable for the families. A taxi can be arranged when needed.

All families receive a gift certificate, adding up to 1000 DKK if all 3 assessments are completed.

Combined with a pragmatic approach, and an emphasis on the importance of participating in research, this hopefully keep enrolled families in the study and makes them complete follow-up interviews.

Data management and confidentiality {19} {27}

All data including personal information about enrolled participants is collected by the assessors during the interview in the secure web application for building and managing online surveys and databases, REDCap (Harris et al., 2009). The surveys for the parents are either answered on site or at home. The surveys for the children are either read out or filled in independently on site depending on the child’s age, ability to read and comprehension of the questions. REDCap has a complete audit trail on all data transactions, detailed user rights and access control management complying with Danish legislation (Databeskyttelsesforordningen). Data for each participant is connected to a unique serial number. Only assigned researchers can access REDCap with all the data. All written statements of consent are kept in a locked file cabinet. Research data will be exported from REDCap without personal identifiers.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}

Tests will be two-tailed. The primary outcome analysis will be an intention-to-treat (ITT) analysis. Analysis of covariance (ANCOVA) will be used to calculate any significant results between the two groups, using the baseline value and the gender of the child as stratification variables.

Methods for additional analyses (e.g., subgroup analyses) {20b}

None.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

Missing data are analysed according to the intention-to treat principles, i.e., analysing individuals to their allocated groups regardless of e.g., protocol non-adherence. Multiple imputations will be used to handle missing data. The imputations will be based on a linear regression model with 100 imputations and 20 iterations. The pooled analyses will subsequently be used for our analysis. As predictors in the imputation model, we will select variables if they are independent predictors of the outcome or predictors of missing data (P < 0.05 in a univariate model).

Data monitoring and harms {21a} {22}

This study does not have a data monitoring committee. All participants randomized to the Family Talk intervention will be monitored for any harmful effect by the clinician who provides the intervention. If necessary, the principal investigator will make the final decision to terminate the trial. In addition, parents in the Family Talk Intervention group answer the Negative Effects Questionnaire (NeQ) (Rozental et al., 2019) investigating negative effects in the intervention.

Interim analyses {21b}

There will be no interim analyses.

Auditing {23}

The trial does not have an independent data monitoring committee. The study will be conducted in accordance with the currently approved protocol. See also {5d}

Ethics and dissemination

Research ethics approval {24}

The Research Ethics Committee was approached and, due to the nature of the study design, they saw no need for approval. Journal-nr.: 19039592, Date 02-07-2019.

Protocol amendments {25}

All changes will be communicated to sponsors and other relevant parties. In addition, deviations from the published protocol will be documented in the trial registration on ClinicalTrials.gov (Unique Protocol ID: 127849).

Consent or assent {26a}

The assessors will obtain informed consent from all participants and children above the age of 15. The custodian(s) must consent to the children participating in the trial (if custody is shared, both parents need to give their informed consent).

Referred participants will undergo a process of informed consent which includes receiving written information regarding the type of intervention, potential risks/side effects and the study design. The researchers ensures that the patient fully understands the information given and accepts being randomly assigned to either the Family Talk intervention or service as usual. Participation in the study is voluntary, and the families can withdraw their consent at any time.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

On the consent form the patients can decide to accept being contacted in the future regarding the outcome of the study. Patients who decline this option still participate in the study. Patients can also decide whether the researchers can have access to their personal patient records. Furthermore, patients can give consent to recording of video- and audio files, and if these can be used for educational purposes.

The authors declare that they have no competing interests.

Access to data {29}

AR, LJM, SN and CH will have access to the final data set.

Ancillary and post-trial care {30}

When protection concerns arise about participating children in the trial, and when more comprehensive support for the family is deemed necessary than offered in Family Talk or SAU, the family is referred to Child Protection Services by a Notification of concern.

Dissemination policy {31a}

The researchers will communicate trial results to participants, healthcare professionals, the public, and other relevant groups via publication in peer reviewed journals, scientific meetings, and public talks.

Authors’ contributions {31b}

AR is the Chief Investigator; she conceived the study, led the proposal and protocol development. AT, MN and NR contributed to study design and to development of the proposal. CH was the lead trial methodologist. SN, LJM, AR, NQ, and KB drafted the manuscript. All authors read and approved the final manuscript.

Plans to give access to the full protocol, participant level-data and statistical code {31c}

The document constitutes the full trial protocol. Following completion of the trial, datasets and statistical code used in this study will be available from the corresponding author on reasonable requests.

Appendices

Not applicable.

Biological specimens {33}

None.

In this paper we have described the planned investigation of the effect of Family Talk Preventive Intervention versus service as usual for families where parents have a mental illness – The SAFIR project – which is to be carried out in context of the Danish Mental Health Services. Prevention in mental health is a relatively under-developed area especially in comparison with prevention in physical health (Arango et al., 2018). Given the magnitude of the public health problem of mental illness, as well as the tremendous economic costs to society and the associated personal suffering, it is striking that mental illness is still almost exclusively treated as it arises. A basic principle of prevention is that early intervention is more efficient and requires fewer resources than treating an established illness. This principle is the foundation of Family Talk as developed by Beardslee over 40 years ago. As of 2021, the SAFIR initiative is in line with the strategic approach proposed by Arango et al (Arango et al., 2018) in which different populations are triaged for preventive intervention according to their level of risk for mental illness. According to this hierarchy children of parents with mental illness requires selective primary preventive intervention which should be “effective and associated with low risk of adverse events and moderate costs”. Indeed, Family Talk is associated with moderate costs and has been documented to have low prevalence of adverse events (Beardslee, 2019), but the effects of the intervention are still unclear. One challenge to prevention research is the choice of appropriate measurements to document effects, and in mental health research the development of such measurements is still immature. The expected effects are on a continuum of the endpoint i.e., future mental illness in the children, to more intermediate effects during and shortly after the intervention. To document short-term effects on the endpoint is unrealistic as most children will not have developed a mental illness regardless of a preventive intervention. While instruments for measurement of presence and severity of mental illness are well developed, determining the immediate and short-term effects face different challenges: Which factors can be expected to change on short term due to the preventive interventions? For whom will the change take place (children and/or parents) and which instruments are best suited to document this change? Those are crucial questions. For the most part, previous RCTs on Family Talk have not been successful in documenting effects on measures of clinical or subclinical symptoms of mental health problems and behavior (Beardslee et al., 2007), suggesting that such measures are not sensitive to short-term effects of the intervention. Also, in order to measure effects on psychiatric diagnosis of the children a very large sample size is needed. In Germany (Wiegand-Grefe et al., 2021) a similar Family talk intervention study plans to investigate children’s mental health determined with Kiddie-SADS-PL as the primary outcome, requiring an estimated sample size of 800 families to show a significant change in psychopathology in the child over an 18-month follow-up period. The most prominent effects in previous trials have been noted for changes in behavior such as talking about mental illness (children and parents) and attitudes concerning mental illness such as reduction in feelings of shame and guilt (parents). However, the longest follow-up time was 4.5 years (Beardslee, 2019), and thus it has not been investigated if these factors can be used as reliable indicators of risk reduction in terms of mental illness in the children. Due to the scientific challenge in preventive psychiatry, we chose intermediate measurements concerning the child, the parent(s) and the family. Level of functioning, C-GAS, can detect change both within the normal, subclinical and clinical area of functioning, thus avoiding floor and ceiling effects in the data. This is important, as only few children will have developed any psychiatric symptoms or be in acute need of Child Protection Services during the one-year follow-up. It is more likely that the children’s level of daily functioning will change over this follow-up interval. The Parental Sense of Competency questionnaire, which is a validated instrument, was chosen to measure parents’ experiences of competency in their parenting role, the rationale being that, according to the theory of change in Family Talk, positive changes in children takes place through changes in their parents.

Strengths

Our study will provide an important contribution to the international evidence base for the Family Talk Intervention in numerous ways, including the RCT design, the number of families included from a help seeking, clinical population, the modifications of the method to include families with any mental illness and our primary outcomes, shedding light on new aspects of the effects of the intervention.

The national Danish registers makes long-term follow-up of the SAFIR cohort possible in the future to examine whether the intervention had an impact on the development of mental disorders and other important indicators of adult adjustment in the children. The unique personal identification number assigned to all live-born children and new residents in Denmark since 1968 can be used to link data from the SAFIR cohort to different registers with information on psychiatric diagnoses, socioeconomic position etc. on an individual level (Erlangsen & Fedyszyn, 2015). It will also be possible to contact parents and children again and gain new information by surveys and interviews.

One of the key strengths is the sample size of 286 participating families – an ambitious but realistic goal. Outcomes from the four earlier randomized, clinical trials have included between 28 and 109 participating families (Beardslee et al., 1996; Solantaus et al., 2010).

In our study the method is extended to include patients with any psychiatric disorder, building upon the findings of the Swedish study which included 103 parents with either depression, psychosis, personality disorder or eating disorder (Pihkala et al., 2010). Their findings support the assumption that Family talk is safe and feasible in transdiagnostic psychiatric populations but was based on a rather small sample size. A further strength of our study is the many measures where the child is the informant. Whereas for instance Solantaus and colleagues used the Strengths and Difficulties Questionnaire as informed by the parents (Solantaus et al., 2010) we chose measures where the child is the informant to avoid possible bias from the parents associated with factors such as parental psychopathology and to obtain information directly from the child. The inclusion of the other parent, i.e. the parent who is not a patient, is also important as previous studies (Afzelius et al., 2018) suggest that they often feel unsupported by mental health services regarding the care that they provide and would like services to consult and involve them more in the treatment process. Considering the other parent is also important as higher prevalence of mental illness and lower levels of functioning have been noted for individuals who had a child by a partner with a mental illness (Greve et al., 2021).

Limitations

Many difficulties in recruitment have been described in a study on preventive programs for children of parents with mental illness (Van Doesum et al., 2016). Clinicians’ workload is an important issue as they drive the referral of families to this study. Parental double stigma (i.e., mental illness and struggling with parenting) might prevent families from participating, perhaps due to a fear being judged as unfit parents or of having the children removed by social services.

A common problem in all clinical trials is how to avoid attrition, in our case especially in the control group of families who did not receive Family Talk. As a means to keep families in the trial gift certificates are offered at follow-up assessments. It is also made clear that the contributions made by the family in participating at follow-up is of great importance of gaining knowledge on how to prevent future mental illness.

Another possible limitation is that of a selection bias in the parents who chose to participate in the trial and a non-representative population of parents with mental illness. For instance, a selection where parents with either relatively high or low levels of psychiatric symptoms or functioning might choose to participate. In that case the results of the study might not be applicable to a general population of parents with mental illness.

Due to the worldwide Covid-19 pandemic throughout 2020 and 2021 the recruitment period was delayed and prolonged because of cancellations from families with Covid-like symptoms or because of restrictions. The CONSERVE-SPIRIT guidelines (Orkin et al., 2021) for reporting trial protocols during the Covid-19 pandemic is included as additional file 2.

Trial status

Recruitment began September 15th, 2020 and is expected to be completed December 2024. As of October 23^rd, 2022, 142 families have been randomized to either Family Talk or service as usual.

Acknowledgements

Ingelise Nordenhof, Jens Richardt Møllegaard Jepsen, Anita Cederström and Eybjørg Egilsdóttir.

Afzelius M, Plantin L, Östman M. Families living with parental mental illness and their experiences of family interventions. J Psychiatr Ment Health Nurs. 2018;25(2):69–77. https://doi.org/10.1111/JPM.12433.
AK M, GI, K., & J D. The family assessment device: an update. Fam Process. 2015;54(1):82–93. https://doi.org/10.1111/FAMP.12080.
Arango C, Díaz-Caneja CM, McGorry PD, Rapoport J, Sommer IE, Vorstman JA, McDaid D, Marín O, Serrano-Drozdowskyj E, Freedman R, Carpenter W. Preventive strategies for mental health. The Lancet Psychiatry. 2018;5(7):591–604. https://doi.org/10.1016/S2215-0366(18)30057-9.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plan. 1982;5(3):233–7. https://doi.org/10.1016/0149-7189(82)90074-X.
Beardslee WR. Master Clinician Review: Parental Depression and Family Health and Wellness: What Clinicians Can Do and Reflections on Opportunities for the Future. J Am Acad Child Adolesc Psychiatry. 2019. https://doi.org/10.1016/j.jaac.2019.02.008.
Beardslee WR, Versage EM, Wright EJ, Salt P, Rothberg PC, Drezner K, Gladstone TRG. Examination of preventive interventions for families with depression: Evidence of change. Dev Psychopathol. 1997;9(1):109–30. https://doi.org/10.1017/s0954579497001090.
Beardslee WR, Wright EJ, Forbes P. Long-Term Effects From a Randomized Trial of Two Public Health Preventive Interventions for Parental Depression. J Fam Psychol. 2007;21(4):703–13. https://doi.org/10.1037/0893-3200.21.4.703.
Beardslee WR, Wright E, Rothberg PC, Salt P. Response of Families to Two Preventive Intervention Strategies: Long-Term Differences in Behavior and Attitude Change. J Am Acad Child Adolesc Psychiatry. 1996;35(6):774–82. https://doi.org/10.1097/00004583-199606000-00017.
Bosch A, van de Ven M, van Doesum K. Development and Validation of the Guilt and Shame Questionnaire for Adolescents of Parents with a Mental Illness (GSQ-APMI). J Child Fam stud. 2020;29(4):1147–58. https://doi.org/10.1007/S10826-019-01671-7/TABLES/3.
Brockington I, Chandra P, Dubowitz H, Jones D, Moussa S, Nakku J, Ferre IQ. WPA guidance on the protection and promotion of mental health in children of persons with severe mental disorders. World Psychiatry. 2011;10(2):93–102. https://doi.org/10.1002/j.2051-5545.2011.tb00023.x.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. (2013). SPIRIT 2013 statement: Defining standard protocol items for clinical trials. In Annals of Internal Medicine (Vol. 158, Issue 3, pp. 200–207). American College of Physicians. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.
Christesen AMS, Knudsen CK, Fonager K, Johansen MN, Heuckendorff S. (2021). Prevalence of parental mental health conditions among children aged 0–16 years in Denmark: A nationwide register-based cross-sectional study. Scand J Public Health, August, 1–9. https://doi.org/10.1177/14034948211045462.
de Angel V, Prieto F, Gladstone TRG, Beardslee WR, Irarrázaval M. The feasibility and acceptability of a preventive intervention programme for children with depressed parents: Study protocol for a randomised controlled trial. Trials. 2016;17(1):1–10. https://doi.org/10.1186/s13063-016-1348-7.
Ellersgaard D, Jessica Plessen K, Richardt Jepsen J, Soeborg Spang K, Hemager N, Burton K, Jerlang Christiani B, Gregersen C, Søndergaard M, Uddin A, Poulsen MJ, Greve G, Gantriis A, Mors D, Nordentoft O, M., & Elgaard Thorup AA. Psychopathology in 7-year-old children with familial high risk of developing schizophrenia spectrum psychosis or bipolar disorder - The Danish High Risk and Resilience Study - VIA 7, a population-based cohort study. World Psychiatry. 2018;17(2):210–9. https://doi.org/10.1002/wps.20527.
Erlangsen A, Fedyszyn I. Danish nationwide registers for public health and health-related research. Scand J Public Health. 2015;43(4):333–9. https://doi.org/10.1177/1403494815575193.
Furlong M, McGilloway S, Mulligan C, McGuinness C, Whelan N. Family Talk versus usual services in improving child and family psychosocial functioning in families with parental mental illness (PRIMERA—Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children): study protocol for a randomi. Trials. 2021;22(1):1–18. https://doi.org/10.1186/s13063-021-05199-4.
Giannakopoulos G, Solantaus T, Tzavara C, Kolaitis G. Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial. J Affect Disord. 2021;278:114–21. https://doi.org/10.1016/j.jad.2020.09.070.
Gibaud-Wallston J. (1977). Self-esteem and situational stress: Factors related to sense of competence in new parents. Peabody College for Teachers of Vanderbilt University ProQuest Dissertations Publishing.
Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009;35(1):48–55. https://doi.org/10.1111/J.1365-2214.2008.00867.X.
Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry Allied Discip. 1997;38(5):581–6. https://doi.org/10.1111/J.1469-7610.1997.TB01545.X.
Greve AN, Uher R, Als TD, Jepsen JRM, Mortensen EL, Gantriis D, Lou, Ohland J, Burton BK, Ellersgaard D, Christiani CJ, Spang KS, Hemager N, Plessen KJ, Thorup AAE, Bliksted V, Nordentoft M, Mors O. A Nationwide Cohort Study of Nonrandom Mating in Schizophrenia and Bipolar Disorder. Schizophr Bull. 2021;47(5):1342–50. https://doi.org/10.1093/schbul/sbab021.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. https://doi.org/10.1016/J.JBI.2008.08.010.
Jefferies P, McGarrigle L, Ungar M. The CYRM-R: A Rasch-Validated Revision of the Child and Youth Resilience Measure. J Evidence-Based Social Work (2019). 2018;16(1):70–92. https://doi.org/10.1080/23761407.2018.1548403.
Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. (1997). Schedule for affective disorders and schizophrenia for school-age children-present and lifetime version (K-SADS-PL): Initial reliability and validity data. J Am Acad Child Adolesc Psychiatry, 36(7), 980–8. https://doi.org/10.1097/00004583-199707000-00021.
Maybery DJ, Reupert AE, Patrick K, Goodyear M, Crase L. Prevalence of parental mental illness in Australian families. Psychiatr Bull. 2009;33(1):22–6. https://doi.org/10.1192/pb.bp.107.018861.
Miller IW, Epstein NB, Bishop DS, Keitner GI. THE McMASTER FAMILY ASSESSMENT DEVICE: RELIABILITY AND VALIDITY. J Marital Fam Ther. 1985;11(4):345–56. https://doi.org/10.1111/j.1752-0606.1985.tb00028.x.
Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010;17(3):231–9. https://doi.org/10.1002/CPP.658.
Orkin AM, Gill PJ, Ghersi D, Campbell L, Sugarman J, Emsley R, Steg PG, Weijer C, Simes J, Rombey T, Williams HC, Wittes J, Moher D, Richards DP, Kasamon Y, Getz K, Hopewell S, Dickersin K, Wu T, … Concato J. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement. JAMA. 2021;326(3):257–65. https://doi.org/10.1001/JAMA.2021.9941.
Pedersen G, Karterud S. The symptom and function dimensions of the Global Assessment of Functioning (GAF) scale. Compr Psychiatr. 2012;53(3):292–8. https://doi.org/10.1016/J.COMPPSYCH.2011.04.007.
Pihkala H, Cederström A, Sandlund M. (2010). Beardslee’s Preventive Family Intervention for Children of Mentally Ill Parents: A Swedish National Survey. Int J Mental Health Promotion, 12(1). https://doi.org/10.1080/14623730.2010.9721804.
Rabinowitz J, Opler M, Rabinowitz AA, Negash S, Anderson A, Fu DJ, Williamson D, Kott A, Davis LL, Schooler NR. Consistency checks to improve measurement with the Personal and Social Performance Scale (PSP). Schizophr Res. 2021;228:529–33. https://doi.org/10.1016/J.SCHRES.2020.11.040.
Ranning A, Benros ME, Thorup AAE, Davidsen KA, Hjorthøj C, Nordentoft M, Laursen TM, Sørensen H. (2019). Morbidity and Mortality in the Children and Young Adult Offspring of Parents With Schizophrenia or Affective Disorders—A Nationwide Register-Based Cohort Study in 2 Million Individuals. Schizophr Bull, 1–10. https://doi.org/10.1093/schbul/sbz040.
Ranning A, Hjorthøj C, Jensen KB, Ebsen FC, Svendsen IL, Thorup AAE, Nordentoft M. Children of Patients Undergoing Psychiatric Treatment: An Investigation of Statutory Support Services After Referrals to Child Protection Services. Front Psychiatry. 2020;11(June):1–10. https://doi.org/10.3389/fpsyt.2020.00527.
Ranning A, Laursen T, Agerbo E, Thorup A, Hjorthoj C, Jepsen JRM, Nordentoft M. School performance from primary education in the adolescent offspring of parents with schizophrenia and bipolar disorder- A national, register-based study. Psychol Med. 2018;48(12):1993–2000. https://doi.org/10.1017/S0033291717003518.
Ranning A, Laursen TM, Thorup A, Hjorthøj C, Nordentoft M. Children of Parents with Serious Mental Illness: With Whom Do They Grow up? - A Prospective, Population-based Study. J Am Acad Child Adolesc Psychiatry. 2016;55(11):953–61. https://doi.org/10.1016/j.jaac.2016.07.776.
Rasic D, Hajek T, Alda M, Uher R. Risk of mental illness in offspring of parents with schizophrenia, bipolar disorder, and major depressive disorder: A meta-analysis of family high-risk studies. Schizophr Bull. 2014;40(1):28–38. https://doi.org/10.1093/schbul/sbt114.
Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, Power M, Duer W, Cloetta B, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J, Fuerth K, Czerny L, Simeoni MC, Robitail S, … Phillips K. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Research: Int J Qual Life Aspects Treat Care Rehabilitation. 2007;16(8):1347–56. https://doi.org/10.1007/S11136-007-9240-2.
Reupert AE, Maybery J, D., & Kowalenko NM. (2013). Children whose parents have a mental illness: prevalence, need and treatment. In The Medical journal of Australia (Vol. 199, Issue 3, pp. S7–S9). https://doi.org/10.5694/mja11.11200.
Rozental A, Kottorp A, Forsström D, Månsson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019;47(5):559–72. https://doi.org/10.1017/S1352465819000018.
Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A Children’s Global Assessment Scale (CGAS). Arch Gen Psychiatry. 1983;40(11):1228–31. https://doi.org/10.1001/archpsyc.1983.01790100074010.
Solantaus T, Paavonen EJ, Toikka S, Punamäki RL. Preventive interventions in families with parental depression: children’s psychosocial symptoms and prosocial behaviour. Eur Child Adolesc Psychiatry. 2010;19(12):883–92. https://doi.org/10.1007/s00787-010-0135-3.
Thastum M, Ravn K, Sommer S, Trillingsgaard A. Reliability, validity and normative data for the Danish Beck Youth Inventories. Scand J Psychol. 2009;50(1):47–54. https://doi.org/10.1111/J.1467-9450.2008.00690.X.
Thorup AAE, Laursen TM, Munk-Olsen T, Ranning A, Mortensen PB, Plessen KJ, Nordentoft M. Incidence of child and adolescent mental disorders in children aged 0–17 with familial high risk for severe mental illness - A Danish register study. Schizophr Res. 2018;197:298–304. https://doi.org/10.1016/j.schres.2017.11.009.
Van Doesum KTM, Riebschleger J, Carroll J, Grové C, Lauritzen C, Mordoch E, Skerfving A. Successful recruitment strategies for prevention programs targeting children of parents with mental health challenges: An international study. Child and Youth Services. 2016;37(2):156–74. https://doi.org/10.1080/0145935X.2016.1104075.
van Santvoort F, Hosman CMH, Janssens JMAM, van Doesum KTM, Reupert A, van Loon LMA. The Impact of Various Parental Mental Disorders on Children’s Diagnoses: A Systematic Review. Clin Child Fam Psychol Rev. 2015;18(4):281–99. https://doi.org/10.1007/s10567-015-0191-9.
WHO. (2016). International statistical classification of diseases and related health problems ICD-10: instruction manual. WORLD HEALTH ORGANIZATION -WHO Nternational Statistical Classification of Diseases and Related Health Problems ICD-10: Instruction Manual, 2, 252.
Wiegand-Grefe S, Filter B, Busmann M, Kilian R, Kronmüller KT, Lambert M, Norra C, von Klitzing K, Albermann K, Winter SM, Daubmann A, Wegscheider K, Plass-Christl A. Evaluation of a Family-Based Intervention Program for Children of Mentally Ill Parents: Study Protocol for a Randomized Controlled Multicenter Trial. Front Psychiatry. 2021;11(January):1–13. https://doi.org/10.3389/fpsyt.2020.561790.
Williams J, Leamy M, Bird V, Le Boutillier C, Norton S, Pesola F, Slade M. Development and evaluation of the INSPIRE measure of staff support for personal recovery. Soc Psychiatry Psychiatr Epidemiol. 2015;50(5):777–86. https://doi.org/10.1007/S00127-014-0983-0.
Williams J, Leamy M, Le Boutillier BV, Norton C, Pesola S, Slade F M. Development and Evaluation of the INSPIRE measure of staff support for personal recovery. Social Psychiatric Epidemiology. 2015;50:777–86. https://doi.org/10.1007/s00127-014-0983-0.

Table 1 is available in the Supplementary Files section.

Download PDF

Journal Publication

published 22 Apr, 2023

Read the published version in Trials →

Reviewers agreed at journal
14 Dec, 2022
Reviewers invited by journal
14 Dec, 2022
Editorial decision: Major revision
14 Dec, 2022
Editor assigned by journal
30 Nov, 2022
First submitted to journal
16 Nov, 2022

You are reading this latest preprint version

A study protocol for the randomized clinical trial SAFIR FAMILY TALK: a selective primary preventive intervention vs. service as usual for children of parents with mental illness.

Status:

Journal Publication

Version 1

Abstract

Background

Methods

Discussion

Figures

Administrative Information

Background And Rationale {6a}

Methods: Monitoring

Discussion

Declarations

References

Tables

Supplementary Files

Status:

Journal Publication

Version 1