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Completed

NCT Number: NCT07582627

Acceptance and Commitment Therapy for Parents of Children With ASD: Effects on Cognitive Fusion, Stigma, and Mindfulness

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:

* Does ACT reduce affiliate stigma among parents of children with ASD? * Does ACT reduce cognitive fusion among parents of children with ASD? * Does ACT improve mindfulness levels among parents of children with ASD? * Does ACT reduce mental health problems (depression, anxiety, and stress) among parents of children with ASD? * Does ACT influence perceived social support among parents of children with ASD?

Participants will take part in an ACT-based intervention program and complete questionnaires before and after the intervention. Specifically, participants will:

* Attend structured ACT sessions delivered online over five weeks. * Complete questionnaires measuring affiliate stigma, cognitive fusion, and mindfulness before the intervention. * Complete the same questionnaires after the intervention to assess changes.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jazan Health Cluster

Jizan, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parents or caregivers have children diagnosed with ASD,
  • Age from 18 to 65 years old.
  • Both sexes
  • willing to participate in the study and able to communicate.

Exclusion criteria

Caregivers with physical and mental disabilities were excluded.

Treatment and study plan

Acceptance and Commitment Therapy (ACT)

Behavioral

Acceptance and Commitment Therapy (ACT) is a structured behavioral intervention designed to enhance psychological flexibility through mindfulness, acceptance, and value-based action. In this study, ACT was delivered online by a trained mental health nurse to parents of children with Autism Spectrum Disorder. The intervention consisted of multiple sessions conducted weekly over several weeks. Sessions included psycho-education about ACT principles, mindfulness exercises, cognitive fusion techniques, and strategies to promote acceptance and value-driven behavior. Participants engaged in interactive discussions, guided activities, and homework assignments. The intervention aimed to reduce cognitive fusion and affiliate stigma while improving mindfulness. Outcome measures were assessed before and after the intervention to evaluate effectiveness.

Primary outcomes

  1. Cognitive Fusion

    Time frame: - Baseline (Week 0) - Post-intervention (Week 5)

    Cognitive fusion will be assessed using the Cognitive Fusion Questionnaire (CFQ), a 7-item self-report scale rated on a 7-point Likert scale. Higher total scores indicate greater cognitive fusion and lower psychological flexibility.

  2. Affiliate Stigma

    Time frame: - Baseline (Week 0) - Post-intervention (Week 5)

    Affiliate stigma will be measured using the Affiliate Stigma Scale (ASS), a 22-item self-report instrument assessing affective, cognitive, and behavioral domains. Each item is rated on a 4-point Likert scale, with higher scores indicating greater levels of stigma experienced by parents of children with Autism Spectrum Disorder.

  3. Mindfulness

    Time frame: - Baseline (Week 0) - Post-intervention (Week 5)

    Mindfulness will be measured using the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 10-item self-report scale assessing attention, awareness, and acceptance. Higher scores indicate greater levels of mindfulness.

  4. Depression, Anxiety, and Stress

    Time frame: - Baseline (Week 0) - Post-intervention (Week 5)

    Psychological distress will be measured using the 21-item Depression, Anxiety, and Stress Scale (DASS-21). It assesses emotional states across three subscales, with higher scores indicating greater distress.

  5. Perceived Social Support

    Time frame: - Baseline (Week 0) - Post-intervention (Week 5)

    Perceived social support will be assessed using the 12-item Multidimensional Scale of Perceived Social Support (MSPSS), measuring support from family, friends, and significant others. Higher scores indicate greater perceived support.

Sponsors and collaborators

Lead sponsor

University of Jazan

Other Gov

Registry information

Official study title

Impact of Acceptance and Commitment Therapy on Cognitive Fusion, Affiliate Stigma, and Mindfulness of Parents to Children With Autism Spectrum Disorder

Acronym: ACT-CFSM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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