Acceptance and Commitment Therapy for Parents of Children With ASD: Effects on Cognitive Fusion, Stigma, and Mindfulness (ACT-CFSM)

May 11, 2026 updated by: Amani Ali Kappi, University of Jazan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Caregivers with physical and mental disabilities were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acceptance and Commitment Therapy (ACT) Group
Participants in this arm received a structured Acceptance and Commitment Therapy (ACT) intervention delivered online. The program consisted of multiple sessions conducted weekly, focusing on mindfulness, acceptance, cognitive fusion, and value-based action. The intervention aimed to reduce cognitive fusion and affiliate stigma while improving mindfulness among parents of children with Autism Spectrum Disorder. Participants completed outcome measures before and after the intervention to assess changes.
Behavioral: Acceptance and Commitment Therapy (ACT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
- Baseline (Week 0) - Post-intervention (Week 5)
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.
- Baseline (Week 0) - Post-intervention (Week 5)
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.
- Baseline (Week 0) - Post-intervention (Week 5)
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.
- Baseline (Week 0) - Post-intervention (Week 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.
- Baseline (Week 0) - Post-intervention (Week 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jazan

Investigators

  • Principal Investigator: Amani A. Kappi, PhD, University of Jazan
  • Study Director: Warda H. Al Shahat, PhD, University of Jazan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2026

Primary Completion (Actual)

February 26, 2026

Study Completion (Actual)

February 26, 2026

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JU-CON-2026-001
  • JU-NUR-ACT-2026 (Other Identifier: Jazan Cluster Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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