Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
The goal of this intervention is to evaluate whether Acceptance and Commitment Therapy (ACT) can improve psychological well-being among parents of children with Autism Spectrum Disorder (ASD) in Saudi Arabia. The study focuses on parents aged 18 years and older who are caring for children diagnosed with ASD. The main questions it aims to answer are:
Participants will take part in an ACT-based intervention program and complete questionnaires before and after the intervention. Specifically, participants will:
Full description
This study aims to evaluate the effectiveness of Acceptance and Commitment Therapy (ACT) in improving psychological outcomes among parents of children with Autism Spectrum Disorder (ASD) in Saudi Arabia. Parents of children with ASD often experience elevated psychological distress, including high levels of cognitive fusion, affiliate stigma, and reduced mindfulness and mental health issues (Depression, anxiety, and stress), which may negatively affect their well-being and caregiver capacity.
Acceptance and Commitment Therapy (ACT) is a third-wave behavioral intervention designed to enhance psychological flexibility through processes such as acceptance, cognitive fusion, present-moment awareness, and values-based action. This study investigates whether participation in an ACT-based intervention can reduce cognitive fusion and affiliate stigma while improving mindfulness and decreasing mental health issues (Depression, anxiety, and stress) among parents of children with ASD.
The study will adopt a quasi-experimental one-group pre-post design. Participants will be recruited from autism support centers, healthcare institutions, and community settings. Eligible participants will complete baseline assessments prior to the intervention, followed by post-intervention assessments using validated instruments to evaluate changes in study outcomes.
Intervention Description:
The ACT intervention will be delivered by a trained mental health professional with expertise in ACT. The program will consist of structured group sessions conducted online via a secure platform. Sessions will focus on core ACT processes, including acceptance of internal experiences, cognitive fusion techniques, mindfulness exercises, values clarification, and committed action.
Each session will include psycho-education, guided experiential exercises, group discussions, and homework assignments to reinforce skill acquisition and application in daily life.
Study Procedures:
Data will be collected at two time points: baseline (pre-intervention) and immediately after completion of the intervention (post-intervention). Standardized self-report instruments will be used to assess cognitive fusion, affiliate stigma, mindfulness, psychological well-being, and mental health issues (Depression, anxiety, and stress). Data collection will be conducted using secure electronic platforms.
Data Quality Assurance:
A structured data quality assurance plan will be implemented to ensure accuracy and completeness. Electronic data entry systems will include predefined validation rules such as range checks, mandatory fields, and logical consistency checks across variables. Periodic data reviews will be conducted to identify and resolve inconsistencies.
Data Monitoring and Verification:
Routine monitoring procedures will be applied to ensure data completeness and reliability. A subset of records will undergo source data verification by comparing entered data with original responses to ensure accuracy. Any discrepancies will be reviewed and corrected by the research team.
Data Dictionary and Coding:
A comprehensive data dictionary will be developed to define all study variables, scoring procedures, and coding systems. Standardized scoring guidelines for validated instruments will be followed to ensure consistency across all participants.
Standard Operating Procedures (SOPs):
Standard Operating Procedures will guide all aspects of the study, including participant recruitment, intervention delivery, data collection, data management, and statistical analysis. SOPs will also address data confidentiality, protocol adherence, and management of any unexpected issues during the study.
Sample Size Considerations:
The sample size is determined based on statistical power analysis to detect meaningful differences between pre- and post-intervention outcomes. The selected sample size is considered adequate to identify moderate intervention effects within a single-group design.
Handling of Missing Data:
Missing data will be assessed for patterns and mechanisms. Appropriate statistical approaches, such as maximum likelihood estimation or multiple imputation, will be applied depending on the extent and nature of missing data. Efforts will be made during data collection to minimize missing responses.
Statistical Analysis Plan:
Descriptive statistics will be used to summarize participant characteristics and baseline measures. Inferential analyses will include paired t-tests or non-parametric equivalents to assess differences between pre- and post-intervention scores. Additional analyses, such as regression modeling, may be conducted to explore predictors of change in outcomes. Statistical significance will be set at p < 0.05.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Caregivers with physical and mental disabilities were excluded.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal