Aim
This protocol aims to employ an RCT design to rigorously evaluate the efficacy of KONTAKT© in supporting the attainment of personally meaningful social goals of adolescents with ASD. The design of this study will address many of the noted limitations of previous SSGT evaluation research, including implementation of a manualised intervention KONTAKT©, controlling for social context, employing a primary outcome measure with adequate power to assess the achievement of adolescents’ personally meaningful social goals, undertaking a cost utility analysis, and investigating the relationship between dose (number of sessions) and the response of adolescents with ASD to a SSGT intervention. The study design stipulates clear inclusion and exclusion criteria, standardized outcomes measures validated for use with adolescents with ASD, blinded assessment of outcome measures, and stratified randomization. This study seeks to answer two research questions: (1) Can KONTAKT© make a unique contribution to facilitate achievement of adolescents’ personally meaningful social goals above and beyond any support provided by the positive social context? (2) Is KONTAKT© cost-effective in comparison to an active control condition?
Design
This will be a stratified (gender, site), randomized controlled trial of a the SSGT program (KONTAKT©) compared to a manualised active control group (a cooking group ‘Super Chef') with a ratio of 1:1, adhering to CONSORT statement for conducting high quality RCTs (48) (figure 1). Data collection will occur at three-time points: (1) at baseline, prior to randomisation to intervention or control; (2) at post-test, immediately following the intervention period; and, (3) at follow-up, 12 weeks following the intervention (primary endpoint).
Participants
Participants will be recruited through the Autism Association of Western Australia (AAWA) with the study promoted via newsletters, parent events and social media. Informed consent/assent will be obtained from both parents and adolescents after receiving detailed verbal and written information about the program, directions in case of adverse events, assessment timelines, and data collection procedures from a member of the research team at Curtin University.
Inclusion criteria
The inclusion criteria for participating in this study will be as follows: 1) A clinical diagnosis of autism, Asperger syndrome, Pervasive developmental disorder- not otherwise specified or ASD according to the DSM-IV (Diagnostic and Statistical Manual of Mental disorders- version IV) (49), or ASD according to DSM-5 (1). This will be further confirmed by administrating the Autism Diagnostic Observation Schedule (ADOS-2) (50); 2) An IQ > 70 on the Wechsler Abbreviated Scale for Intelligence (WASI-II) (51); 3) Aged between 12 to 17 years at randomization.
Exclusion criteria
Participants meeting the following criteria will be excluded from this study: 1) Rule breaking and aggressive behaviours as confirmed by Childhood Behaviour Checklist (CBCL) (52); 2) Prior clinically-assessed self-injurious behaviour; 3) Low intrinsic motivation to participate; and, 4) Insufficient English language skills; 5) A history of clinically assessed self-injury, conduct disorder, hyperkinetic conduct disorder, antisocial personality disorder, borderline personality disorder, or any form of schizophrenia or related psychotic disorder that would interfere with participation or require alternative treatment.
Participants with common comorbid neurodevelopmental and psychiatric conditions such as attention problems, anxious or depressed behaviours as measured by CBCL (52) are acceptable in this trial as in previous evaluations of KONTAKT (17, 32). In addition, the participants may continue with their usual ongoing treatments or interventions.
Sample size calculations
The KONTAKT© study in Sweden (both 12 and 24 week versions), employed the Social Responsive Scale – second edition (SRS-2) as the primary outcome measure. Based on effect size of 0.54, derived from roughly averaging the effect size as measured by the SRS-2 from trials examining the efficacy of the long 24 session (ES=0.76) and the short 12 session (ES=0.32) versions of KONTAKT© at post-test, and applying a MANOVA for repeated measures (within-between interactions) at the three time points (with intent-to-treat approach), a minimum of 57 participants are required (as calculated by G*Power (53) with a power of 0.95 at a conventional error probability (α=5%)). However, unlike the Swedish study, the present study will employ the Goal Attainment Scaling (GAS) as the primary outcome. It has been argued that GAS has a good reliability when used as an outcome measure with interventions for adolescents with ASD (54-56). Further, unlike previous investigation of KONTAKT© (17, 32), the current study will compare this SSGT efficacy against an active control group to control for exposure to a social context with peers with ASD. It is likely that both these factors will have a limiting impact on the power of the study, as such this study will aim to recruit a sample of at least 90 participants, increasing the likelihood of detecting possible effects (19). This sample size will also account for the attrition rate of 37%, which is larger than what is expected based on the previous KONTAKT© studies.
Setting
Participants expressing an interest in the study will be invited to a screening session and, following determination of their eligibility, take part in a baseline assessment in a university laboratory at Curtin University, Perth, Western Australia. Both the KONTAKT© group and the active control cooking group will be delivered by AAWA in one of their four metropolitan centres, in Perth, Western Australia. The AAWA is the leading service provider for people with ASD in Western Australia, the only specialist organisation providing a full range of services for children and adults in Australia, with over 700 multi-disciplinary staff.
Randomization
Participants will be stratified for gender and then randomly allocated to either KONTAKT© (intervention group) or the ‘Super Chef’ cooking group (active control group) across AAWA centres. The randomization will be conducted by a statistician and sent directly to the AAWA study coordinator, supporting blind assessment of outcome measures by the research team.
The interventions
In evaluating the feasibility and acceptability of KONTAKT© in an Australian context, a pilot version of 16 session KONTAKT© was delivered to 16 adolescents meeting the inclusion criteria across 16 sessions in 20 weeks, with two 8-week session blocks interspersed with the Australian school holidays. After completing the KONTAKT© intervention focus groups were held with participants, parents and trainers, capturing their perspectives of the program. Following analysis of focus group data, final adjustments and modifications were made to the KONTAKT© 16-week variant, standardising the intervention in preparation for RCT evaluation. Tables 1 and 2 detail the structure and content of KONTAKT© (the opportunity to choose social themes/activities that reflects the participants’ personal goals or interests) and ‘Super Chef’ (personal tastes for each recipe) sessions, and their emphasis on individualized activities aiming to promote motivation in the participants and generalization of skills (32).
The Australian adaptation of KONTAKT© employing a 16 session variant, aims to improve participants communication and social interaction skills, ASD related traits, and the ability to empathise and adapt in a group setting, of 6 to 8 adolescents aged 12 to 17 years (19, 21). Groups meet weekly for an hour and a half, with two trainers delivering a program underpinned by the principles of cognitive behaviour therapy, behaviour activation, observational learning, psychoeducation and social cognition training (41, 42). Sessions scaffold knowledge of common social rules and norms, aiming to promote problem solving strategies, emotion recognition and emotion expression (19).
Table 1. The structure, objectives and individualized parts of weekly KONTAKT© sessions (57).
|
Rounds
|
Objective
|
Individualized activity
|
Opening
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Warm-up activity, initiating conversation, promoting interaction between group members, promoting eye-contact
|
|
Reviewing homework
|
Reinforcing and providing feedback, troubleshooting if necessary
|
Sessions 2-15
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Group discussion
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Exchanging experiences, promoting social cognition and social relationship
|
Sessions 12-15
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Group activities
|
Providing practical solutions and strategies for everyday challenging social situations, fostering a feeling of group cohesion, practicing cooperation, practicing recognising and interpreting non-verbal signals, eye-contact, and facial expressions
|
Sessions 12-15
|
Snack time
|
Practicing small-talk and turn-taking in unstructured conversations
|
|
Assigning new homework
|
Generalizing learnt skills to everyday social situations
|
Fixed: Sessions 1-10
Flexible: Sessions 11-14
|
Closing
|
Evaluating the session, promoting interaction between group members
|
|
KONTAKT© requires that at least one group trainer is a clinician with extensive experience working with children/adolescents with ASD, who has also received methodological training, or certification in KONTAKT© prior to the program. Prior to the pilot, Australian clinicians from AAWA were trained by a Swedish team of certified KONTAKT© trainers. Requirements of KONTAKT© training certification include passing this method training, leading at least one KONTAKT© group under supervision, and achieving intervention fidelity as assessed by a KONTAKT© supervisor on the basis of submission of a filmed KONTAKT© session. A KONTAKT© certified trainer can, in turn, instruct others in delivering KONTAKT©. In the present study, fidelity to the KONTAKT© intervention will be systematically assessed by trainers completing a session by session fidelity checklist, enabling an assessment of intervention fidelity. In addition, attendance sheets will be kept to record the participants’ compliance to the program, with 80% attendance considered as compliant.
‘Super Chef’ is a manualized cooking group program specifically designed for this study (table 2), with the goal of enabling comparison of KONTAKT© with an active social control group, enabling independent evaluation of the contribution of KONTAKT© to intervention outcomes. As in KONTAKT©, participants allocated to the ‘Super Chef’ program will meet weekly in groups of 6 to 8 for an hour and a half in a 16 session program moderated by two trainers, one of which will be an occupational therapist with previous experience of working with Australian adolescents with ASD. As with KONTAKT©, each ‘Super Chef’ session adheres to a specified agenda including discussions, taste testing, individual and group activities, snack time, cooking recipes, eating and rating recipes and cleaning up as rostered. ‘Super Chef’ was developed by a team including Occupational therapists with both clinical and research experience in working with adolescents with ASD, with consideration of the common sensory issues associated with ASD. Fidelity to the ‘Super Chef’ intervention will be assessed via a fidelity checklist, specially designed for this program, enabling assessment of the extent to which trainers followed the format of each session.
Table 2. The structure, objectives and individualized activities of weekly ‘Super Chef’ sessions.
|
Rounds
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Objective
|
Individualized activity
|
Transition
|
Self-regulation and arrival into the session
|
|
Activity 1
|
Sharing cooking experiences
|
|
Activity 2
|
Preparation for cooking and food exploration
|
Every session
|
Snack time
|
Practicing small-talk and turn-taking in unstructured conversation, participating in games and activities
|
|
Activity 3
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Cooking or baking
|
Every session
|
Eating the prepared meal
|
Rating the prepared meal
|
|
Clean up
|
Washing up, drying dishes, wiping down benches and tables, and sweeping the floor.
|
Every session
|
Transition
|
Recapping the session and feedback to the parents
|
|
Data collection
The data for this study will be collected by the measures as outlined in table 3, at three time points by an assessor blind to group allocation: (1) before the intervention period (pre-intervention); (2) following the completion of the 16-week intervention (post-intervention); and, (3) at 12-weeks following the intervention (follow-up), with follow up being the primary endpoint. Additionally, there will be an 8-week data collection point for the cost analysis study (mid-intervention) (table 3).
Given this study will use an intent-to-treat approach, if participants are unable to finish the program or attend the face to face assessment sessions, they will be contacted and encouraged to complete the questionnaires via email.
Primary outcome measure
Goal Attainment Scaling (GAS) evaluates the outcomes and suitability of an intervention in an individual or group setting (58, 59). Following the guidelines suggested by Kiresuk and colleagues (1994) adolescents randomized to both the treatment and control group, will establish at least three personally meaningful and measurable social goals in collaboration with an assessor blinded to the group allocation. The achievement of these goals will be scored via the GAS scoring system of ”-2” showing the participant’s current level of performance, “-1” less than expected, “0” the expected progress, and “+1” and “+2” indicative of progress above the expected level (60). As suggested by previous research, the GAS reliability will be calculated for this sample (54).
Secondary outcome measures
The Social Responsiveness Scale – Second Edition (SRS-2) standard version is a 65-item parent rating scale, designed to measure autistic-like traits in individuals aged 4 to 18 years. The SRS-2 enables calculation of a total score and five subscales: social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behaviour. The scale is scored on a 4-point Likert scale, ranging from “not true (0)” to “almost always true (3)”. Scores range from 1 to 195 with the expected value for individuals with a primary diagnosis of ASD being approximately 100 (61). Previous studies with individuals with ASD show good psychometric properties for SRS-2 (internal consistency of 0.9) (62, 63). As recommended for research, the raw scores of the measure (total and subscale) will be used in this study (63).
The Circumplex Scale of Interpersonal Efficacy (CSIE) (64) measures an individual’s confidence in regard to their ability to successfully perform behaviours associated with each facet of the interpersonal Circumplex (Assert, Distance, Yield, and Connect). Each octant scale shows a progressive blend of two axial dimensions (e.g. “speak up” representing an assertive action, “get them to leave me alone” a distancing action, and “tell them when I am annoyed” combining these two actions) (65). As suggested by previous research this study will use these dimensional scores instead of the 8 octant to predict the outcome (66). Previous studies with Adolescents with ASD have demonstrated an acceptable internal consistency of 0.78 for this measure (64).
Table 3. Schedule of enrolment, interventions, and assessments
|
Study period
|
|
Involvement
|
Enrolment
|
Allocation
|
Post-allocation
|
A
|
P
|
R1
|
R2
|
TIME POINTS
|
|
|
|
|
-T1
|
0
|
T1
|
T2
|
T3
|
T4
|
ENROLEMENT:
|
|
|
|
|
|
|
|
|
|
|
Eligibility criteria
|
|
|
X
|
|
X
|
|
|
|
|
|
Informed consent
|
X
|
X
|
|
|
X
|
|
X
|
|
X
|
X
|
Allocation
|
|
|
|
|
|
X
|
|
|
|
|
INTERVENTIONS:
|
|
|
|
|
|
|
|
|
|
|
KONTAKT©
|
X
|
X
|
|
|
|
|
X
|
X
|
X
|
X
|
Super Chef
|
X
|
|
|
|
|
|
X
|
X
|
X
|
X
|
ASSESSMENTS:
|
|
|
|
|
|
|
|
|
|
|
Screening
|
CBCL
|
|
X
|
|
|
X
|
|
|
|
|
|
WASI-II, ADOS-2
|
X
|
|
X
|
|
X
|
|
|
|
|
|
Primary outcome
|
GAS
|
X
|
|
X
|
|
|
|
X
|
|
X
|
X
|
Secondary outcomes
|
CSIE, CHU9D, PALs, SIAS
|
X
|
|
|
|
|
|
X
|
|
X
|
X
|
Mind reading Battery
|
X
|
|
X
|
|
|
|
X
|
|
X
|
X
|
ERSSQ, SRS-2
|
|
X
|
|
|
|
|
X
|
|
X
|
X
|
PedsQL 4.0
|
X
|
X
|
|
|
|
|
X
|
|
X
|
X
|
TSS-2
|
X
|
X
|
|
|
|
|
|
|
X
|
|
NEQ
|
X
|
|
|
|
|
|
|
|
X
|
X
|
TIC-P
|
|
X
|
|
|
|
|
X
|
X
|
X
|
X
|
Experience Sampling data
|
X
|
X
|
|
|
|
|
|
|
|
|
Social functioning
|
X
|
|
|
X
|
|
|
X
|
X
|
X
|
|
Note. Time points: T1: Baseline; T2: Mid-intervention; T3: Post-Intervention; T4: Follow-up. Involvement: A: Adolescent; P: Parent/carer; R1: Assessor blinded to the group allocation; R2: Assessor blinded to the hypothesis. Measures: ADOS-2: Autism Diagnostic Observation Schedule – Second Edition; CBCL: Childhood Behaviour Checklist; CHU9D: Child Health Utility 9D; CSIE: The Circumplex Scale of Interpersonal Efficacy; ERSSQ: The Emotion Regulation and Social Skills Questionnaire; GAS: Goal Attainment Scaling; NEQ: The Negative Incidents and Effects of Psychological Treatment; PedsQL 4.0: Pediatric Quality of life Inventory; PALS: Perth A-Loneliness Scale; SIAS: Social Interaction Anxiety Scale; SRS-2: Social Responsiveness Scale; TSS-2: Treatment Satisfaction Scale; TIC-P: Treatment Inventory of Costs in patients; WASI-II: Wechsler Abbreviated Scale of Intelligence – Second Edition.
|
Perth A-Loneliness Scale (PALs) is a self-report measure consisting of 24 statements such as ‘‘I feel left out of things at school’’, or ‘‘I get along with my classmates’’, measuring four dimensions of loneliness in young people (isolation, friendship and positive and negative attitudes toward solitude) (67-69). Responses are recorded on a 6-point Likert scale indicating agreement with a statement, ranging from “never (1)” to “always (6)”, with higher scores suggesting higher levels of loneliness and negative attitude towards solitude. This scale has yielded good reliability for the overall scale and subscales (Cronbach alpha = 0.84). The use of the scale in the current study is further supported by established norms for Western Australian adolescents (67).
The Emotion Regulation and Social Skills Questionnaire (ERSSQ) is a 27-item measure assessing emotion regulation and competency in social skills (70). The questionnaire is designed to measure frequencies of effective engagement in social behaviours (e.g. “chooses appropriate solutions to social problems” or “deals effectively with bullying”), examining the competency of these skills (70). Responses are rated on a 5-point Likert scale, ranging from “never (0)” to “always (4)”, yielding a total score of 0-108, with higher scores indicating higher competencies in social behaviour. ERSSQ has demonstrated good internal consistency for children with ASD (Cronbach’s alpha = 0.89) (70).
Paediatric Quality of life Inventory TM, version 4.0 (PedsQL TM 4.0) is a 23-item parent proxy report and an adolescent self-report measure of adolescent’s quality of life underpinned by the four subscales of physical, emotional, social, and school functioning (39, 71). Responders rate items according to if they have been a problem for them on a 5-point Likert scale ranging from “never (0)” to “almost always (5)”, with lower scores indicating better quality of life. Although there is no ASD specific modules available, the questionnaire has high validity and reliability (Cronbach’s alpha = 0.97) and has been used in adolescents with ASD (12, 39), including Australia youth with ASD (72, 73).
Social Interaction Anxiety Scale (SIAS) is a 20-item measure assessing adolescents’ self-reported anxiety in social situations, via items such as “I become tense if I have to talk about myself” or “I find it easy to make friends my own age”. Items are rated on a 5-point scale ranging from “Not at all” to “extremely”. Total scores range from 0 to 80 with higher scores indicating greater anxiety in social situations. The scale has a good internal consistency and test-retest reliability (Cronbach’s alpha = 0.94) (74) and has been validated in an Australian setting with Australian adults. (75).
Child Health Utility 9D (CHU9D) is a 9-dimension Health related quality of life scale (worried, sad, pain, tired, annoyed, school work, sleep, daily routines and activities), designed to estimate the adolescent’s Quality adjusted life years (QALY), providing a standardized measure of disease burden. The measure is rated on a 5-point scale with a “don’t” sentence linked with no problems (e.g. I don’t feel sad today) and “very” with the participant experiencing a lot of problems (e.g. I feel very sad). Calculation of an universal score is supported by an adolescent specific scoring algorithm, with 1 representing ‘full health’ and 0 ‘death’ (76). Previous research suggests that CHU9D support appropriate calculation of QALYs (77).
Health care consumption and productivity loss will be measured via a tailored version of the Trimbos/iMTA questionnaire for patients with a psychiatric disorder (TiC-P), a well-established questionnaire examining health care usage as well as any work, education and productivity losses incurred by participants and their carers. The modified version of the TIC-P employed in this study comprise six sections enquiring about health care visits, support received both at and outside of school, medications and supplements, work, and education and productivity losses incurred by both parents and adolescents. The feasibly of the inventory was evaluated in the KONTAKT© pilot study.
The Mindreading Battery enables assessment of facial emotion recognition accuracy (78), with this study measuring adolescents performance across forty basic and complex emotions, over 6 developmental levels with level 1 being the simplest (e.g., happy) and level 6 being the most complex (e.g., exonerated) (table 3). Emotions are displayed in the form of 2-5 second silent coloured video clips, with 4 multiple choice options one of which is the correct emotion label and 3 are distractor items. The distracter options were randomly selected from the entire Mind reading battery emotion groups, excluding the emotion group the target stimuli originates from. Further details of the stimuli are outlined in table 4. During the presentation of stimuli, eye tracking data will be recorded via a Remote Eye Tracker Device (RED) developed by SensoMotoric Instruments, enabling examination of fixation patterns and fixation durations (79). While the eye tracker accommodates small head movements, a chin rest will be available to participants who find it hard to sit still. Outcome measures will be assessed in relation to accuracy, response time, and number of and duration of fixations to dynamically defined areas of interest including the eyes, nose and mouth of the stimuli (80, 81).
Table 4. Overview of the Mindreading Stimulus Battery
|
Stimuli characteristics
|
Number of stimuli items
|
Valence
|
|
Negative
|
22
|
Positive
|
16
|
Gender
|
|
Male (Pre)
|
17
|
Male (Post)
|
18
|
Female (Pre)
|
21
|
Female (Post)
|
20
|
Emotion level
|
|
Basic
|
6
|
Level 1 & 2
|
6
|
Level 3 & 4
|
15
|
Level 5 & 6
|
11
|
The Negative Incidents and Effects of Psychological Treatment (NEQ) assesses potential adverse and unwanted events associated with attending the groups at the completion of each program, via adolescent self-report (82). The NEQ is a 32-item questionnaire requiring adolescents to quantify, on 5-point Likert scale with response options ranging from “Not at all” to “Extremely”, any negative events experienced during the intervention period, asking participants to attribute their causality to either the program or external circumstances. Analysis of the measure has shown good reliability (Cronbach’s alpha = 0.95) (82).
The Experience Sampling Method (ESM) will evaluate adolescents’ everyday quality of life via daily responses from both adolescent and parent proxy report (83-85). This 5-item measure, specifically designed for the purposes of this study, asks “In the last 24 hours, on a scale of 1 to 10 I have been feeling …” with answers rated on a 10-point scale regarding five dichotomised emotional sets (sad/happy, lonely/unlonely, angry/calm, scared/unafraid, and anxious/confident). Questions are texted via mobile phones to adolescents and parents once daily from commencement of the groups to the final follow-up time point. The feasibility of this approach was assessed during a pilot study, with this method previously showing consistency across experiences and in examining the effect of social context on the daily experiences of adolescents with ASD (86).
Treatment Satisfaction Scale (TSS-2) (87) is a short 6-item parent and adolescents self-report instrument, measuring satisfaction with group attendance. Each item is scored on a 4-point Likert scale with response options ranging from “Yes, very much” to “No” with an open comment section, encouraging participants to freely share their experiences with the intervention.
Blind expert rating of social functioning will be assessed by an occupational therapist or psychologist, experienced in working with adolescents with ASD blind to the study’s hypothesis via a rating scale designed specifically for the purposes of this study. The scale requires a rating of participant’s social communication and interaction on a scale of 0 to 10 as observed during 3 video recordings of the snack times of sessions 2, 10, 15 of both the intervention group and control groups presented in random order.
Process evaluation
In determining the usability and the facilitators and barriers to both the KONTAKT© and ‘Super Chef’ programs, and the factors likely impacting their efficacy, a process evaluation will be undertaken. Parents, adolescence and trainers’ feedback on both programs will be sought via semi-structured interviews at the completion of the programs. This will provide an in-depth understanding of those factors influencing the relative efficacy of both the KONTAKT© and ‘Super Chef’ programs.
Statistical analyses
As suggested by previous research, reliability of the GAS goals will be investigated via examination of their measurability, equidistance and difficulty [57]. A random effects regression model will be used to explore those factors associated with the GAS raw scores (dependent variable), over the 9-month duration of the study. Independent variables for the model will be: time, group (KONTAKT© vs ‘Super Chef’), age, IQ, gender, centre, comorbidity as fixed effects, with follow-up being the primary endpoint of the study. Random effect will be the participant’s ID number, thus accounting for the correlation between measurements made on the same individual within the model.
Analysis of secondary outcomes (interpersonal efficacy, quality of life, social anxiety, loneliness, facial emotion recognition and eye tracking behaviour), will be conducted in a similar manner (random effects regression model). Analysis will employ an intent-to-treat approach [84], considering each participant as belonging to the study group they were initially allocated, regardless of treatment actually received. Missing data will be accounted for according the guidelines specified for each measure, if no guidance is provided, missing data will be handled in accordance with the CONSORT statement for conducting high quality RCTs (48). Data analysis will be conducted using the SPSS version 24 statistical software (88).
The outcomes of the present study will be compared to results obtained by previous evaluations of the short and long variant of KONTAKT© undertaken in Sweden.
Cost data analyses
Cost data will be analysed from both societal and health care perspectives, including the direct costs of the two experimental interventions, healthcare costs, and societal resource costs. Individual participant costs will be estimated and accumulated over the period of the study (9 months including follow-up). Non-normality of the cost data can be assumed, and therefore missing data will be analysed using a non-parametric imputation model based on random forest estimation. CHU9D scores will be converted to QALYs using previously validated algorithms (76, 89). The cost differences between the two experimental groups over all time points will be analysed via linear regression, using non-parametric bootstrapping with 5000 repetitions for the estimation of adequate confidence intervals, accounting for the skewedness of the data. Cost differences between the two groups will be presented in Australian dollars. As a global measure of cost-effectiveness and in line with international standards, an Incremental Cost Effectiveness Ratio (ICER) will be presented (89), representing the additional cost of one additional QALY when participants receive KONTAKT© instead of ‘Super Chef’. The same analysis will be conducted for the ICER of treatment response that is the additional cost for one responder. To assure robustness of the results, a sensitivity analysis will be conducted by increasing the costs of KONTAKT© by 25%.