Technical Design:
Site of Study: Al Dakahleya governorate, Egypt.
Sample Size: A representative sample of 375 participant of children with ADHD assigned randomly by convenience sampling technique, ages of all participants ranges between 6 and 12 years ,69.3% of those participants were males and 30.7% females, residing in both urban and rural areas, patients were recruited from specialized institutions in Al Mansoura city the capital of Al Dakahleya governorate, Egypt. Open Epi I program was used to calculate the suitable sample size, at confidence interval of 95% and power of 80%, the minimum required number of participants was 370 participants, Diagnosis and severity of symptoms of ADHD cases were based on DSM V, and Conners rating scale(appendix 3) .
Subjects included in the study:
Inclusion criteria:
Male or female ADHD children from community-dwellers aging between 6 and 12 years.
Exclusion criteria:
-Mental disability
-Severe cognitive impairment
Data Collection Tools:
1. Sociodemographic Questionnaire (appendix 1): Collected data on age, gender, parental education, family income, number of siblings, and birth order.
2. Risk Factor Survey(appendix 2): Collected prenatal and familial data, including:
o Paternal smoking.
o Parental consanguinity.
o Maternal intake of sugar, folic acid, iron, and omega-3 during pregnancy.
o Birth order and number of siblings.
o Age of mother at the time of pregnancy.
A Pilot Study (Test-Retest Reliability Analysis) was conducted to test the reliability and validity of the "Sociodemographic Questionnaire" and the "Risk Factor Survey" developed for the main study, the pilot study involved 40 children from th sample of the original study. The aim of this pilot was to evaluate the test-retest reliability of the questionnaires by administering them twice over a two-week period and analyzing the consistency of responses.
Procedures:
- Initial Administration:
Both the "Sociodemographic Questionnaire" and the "Risk Factor Survey" were administered to the parents of the 40 children during their first visit to the clinic.
- Second Administration (Retest):
After a period of two weeks, the same questionnaires were re-administered to the same group of parents under similar conditions.
- Data Collection and Analysis:
Responses from the first and second administration were compared for consistency using correlation analysis, specifically Pearson's correlation coefficient for continuous variables and Cohen's kappa for categorical variables.
3. ADHD Diagnostic Tool: DSM-5 criteria for ADHD diagnosis.
4. ADHD Symptomatology Scale: Conners' Rating Scale.
Socio-demographic Questionnaire (appendix 1) and Risk Factor Survey(appendix 2) to be filled by the parents of children included in the study in presence of researcher, with commitment of the highest levels of confidentiality.
Operational design:
Type of study:
Observational cross-sectional study
Method:
Recruitment and data collection:
The research team attended local organizations specialized in caring for ADHD children in Al Mansoura city, meetings with in charge administrators were conducted to explain all research details, and then meetings with families of candidate children were arranged for the same purpose , the details were explained thoroughly by a team member to parents of every candidate then offered an informed consent to be signed in case of acceptance before beginning of the study to insure complete satisfaction, then the questionnaires were offered to them to be filled (appendex1 and 2). The study was conducted in 6months (from March to September, 2024).
Statistical Plan:
The following statistical plan outlines the approach used for analyzing the correlation between various socio-demographic and risk factors and the severity of ADHD symptoms in the provided dataset.
1. Study Design:
· Study Type: Cross-sectional, comparative case-control study.
· Sample Size: 375 children diagnosed with ADHD, aged 6-12 years.
· Data Source: Sociodemographic Questionnaire and Risk Factor Survey completed by parents.
2. Variables:
· Dependent Variable: Severity of ADHD symptoms (measured using DSM-5 criteria and Conners’ Rating Scale).
· Independent Variables (Predictors):
o Sociodemographic factors: socioeconomic status, parental education, maternal age, number of siblings, birth order.
o Risk factors: paternal smoking, parental consanguinity, maternal folic acid intake, maternal omega-3 intake, maternal iron intake.
3. Statistical Methods:
The following statistical tests and procedures were used to calculate the correlations and assess their significance:
A. Descriptive Statistics:
· Frequencies and Percentages: For categorical variables (e.g., socioeconomic status, parental education, paternal smoking).
· Means and Standard Deviations: For continuous variables (e.g., maternal age, number of siblings).
B. Correlation Analysis:
1. Pearson’s Correlation Coefficient:
o Used for continuous variables (e.g., maternal age, number of siblings) to assess the linear correlation between the factor and ADHD severity.
o Interpretation of r values:
§ r = 0.1-0.3: Weak correlation.
§ r = 0.3-0.5: Moderate correlation.
§ r > 0.5: Strong correlation.
2. Spearman’s Rank Correlation Coefficient:
o Used for ordinal data (e.g., socioeconomic status, parental education) to examine monotonic relationships between these factors and ADHD severity.
o Spearman’s rho was interpreted similarly to Pearson’s r.
3. Chi-Square Test:
o For categorical variables such as paternal smoking (Yes/No), parental consanguinity (Yes/No), and maternal nutritional intake (Yes/No).
o The Chi-square test was used to evaluate whether there was a statistically significant association between the categorical variables and ADHD severity levels (mild, moderate, and severe).
C. Regression Analysis:
· Multiple Logistic Regression:
o Used to determine the independent effect of each predictor (risk and sociodemographic factors) on the severity of ADHD symptoms.
o This analysis adjusted for potential confounders and interactions between factors such as socioeconomic status and parental education.
o Variables with a p-value < 0.05 in bivariate analysis were included in the regression model.
D. P-value Interpretation:
· P < 0.05: Statistically significant correlation.
· P > 0.05: Not statistically significant.
4. Plan for Handling Missing Data:
· Missing data were handled using listwise deletion, where only complete cases were included in the analysis to maintain consistency in sample size across tests.
5. Software:
· All statistical analyses were conducted using IBM SPSS 28 software.
6. Steps in the Statistical Process:
1. Data Entry and Cleaning:
o Input all questionnaire responses and ensure there were no errors in data entry. Outliers were reviewed, and any implausible values were checked for accuracy.
2. Descriptive Statistics:
o Descriptive statistics were generated for all sociodemographic variables and risk factors to summarize the characteristics of the sample.
3. Correlation Calculation:
o Pearson’s or Spearman’s correlation coefficients were calculated for continuous and ordinal variables, respectively.
o Chi-square tests were run for categorical variables (e.g., paternal smoking, consanguinity).
4. Regression Model:
o Variables that showed significant correlations (p < 0.05) were entered into a multiple logistic regression model to adjust for confounders and assess the independent contribution of each factor.
5. Interpretation of Results:
o Correlations were classified based on strength and significance.
o The results of the regression analysis were reviewed to identify key predictors of ADHD severity, accounting for potential interactions.
7. Hypothesis Testing:
· Null Hypothesis (H0): There is no correlation between the sociodemographic/risk factors and ADHD severity.
· Alternative Hypothesis (H1): There is a significant correlation between the socio-demographic/risk factors and ADHD severity.
The null hypothesis was rejected for variables with p < 0.05, indicating that the corresponding factors had a significant correlation with ADHD severity.
Ethical considerations:
A prior ethical approval from the relevant IRB was obtained. All methods were performed in accordance with the relevant guidelines and regulations, the study objectives and design were explained thoroughly by researcher to parent(s)/legal guardian(s) of every candidate then he/she signed an informed consent in case of acceptance before beginning of the study.