NCT07582627

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

April 29, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

Acceptance and Commitment TherapyAutism Spectrum DisorderCaregiversParentsPsychological FlexibilityMindfulnessCognitive FusionStigmaCaregiver BurdenDepressionAnxietyStress

Outcome Measures

Primary Outcomes (5)

  • Cognitive Fusion

    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

    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

    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

    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

    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)

Study Arms (1)

Acceptance and Commitment Therapy (ACT) Group

EXPERIMENTAL

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)

Interventions

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.

Acceptance and Commitment Therapy (ACT) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Caregivers with physical and mental disabilities were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jazan Health Cluster

Jizan, Saudi Arabia

Location

Related Publications (26)

  • Yesilkaya, M., & Magallón-Neri, E. (2024). Parental Stress Related to Caring for a Child With Autism Spectrum Disorder and the Benefit of Mindfulness-Based Interventions for Parental Stress: A Systematic Review. Sage Open, 14(2). https://doi.org/10.1177/21582440241235033

    BACKGROUND
  • Salami, I., & Alhalal, E. (2024). Affiliate stigma among caregivers of children with autism spectrum disorder in Saudi Arabia. BMC Psychology, 12(1), 145. https://doi.org/10.1186/s40359-024-01545-y

    BACKGROUND
  • Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The multidimensional scale of perceived social support. Journal of personality assessment, 52(1), 30-41

    BACKGROUND
  • Wong CCY, Mak WWS, Liao KYH. 2016. Self-compassion: a potential buffer against affiliate stigma experienced by parents of children with autism spectrum disorders. Mindfulness 7(6):1385-1395 DOI 10.1007/s12671-016-0580-2.

    BACKGROUND
  • Mak WWS, Kwok YTY. Internalization of stigma for parents of children with autism spectrum disorder in Hong Kong. Soc Sci Med. 2010 Jun;70(12):2045-2051. doi: 10.1016/j.socscimed.2010.02.023. Epub 2010 Mar 12.

    PMID: 20362379BACKGROUND
  • Mak, W. W., & Cheung, R. Y. (2008). Affiliate stigma among caregivers of people with intellectual disability or mental illness. Journal of applied research in intellectual disabilities, 21(6), 532-545.

    BACKGROUND
  • Mohammed, A. S., Eliwa, S. M., & Zaki, R. A. H. (2020). Relationship between psychological well-being and coping strategies among family caregivers of children with Down syndrome. Egyptian Journal of Health Care, 11(4), 155-172.

    BACKGROUND
  • Lovell B, Wetherell MA. Affiliate stigma, perceived social support and perceived stress in caregivers of children with autism spectrum disorder: A multiple mediation study. Arch Psychiatr Nurs. 2019 Oct;33(5):31-35. doi: 10.1016/j.apnu.2019.08.012. Epub 2019 Aug 20.

    PMID: 31711591BACKGROUND
  • Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety & Stress Scales. (2nd Ed.) Sydney: Psychology Foundation.

    BACKGROUND
  • Lunsky Y, Fung K, Lake J, Steel J, Bryce K. 2017. Evaluation of acceptance and commitment therapy (ACT) for mothers of children and youth with autism spectrum Disorder. Mindfulness 9(4):1110-1116.

    BACKGROUND
  • Kinnear SH, Link BG, Ballan MS, Fischbach RL. Understanding the Experience of Stigma for Parents of Children with Autism Spectrum Disorder and the Role Stigma Plays in Families' Lives. J Autism Dev Disord. 2016 Mar;46(3):942-53. doi: 10.1007/s10803-015-2637-9.

    PMID: 26659549BACKGROUND
  • Alkhateeb JM, Hadidi MS, Mounzer W. The Impact of Autism Spectrum Disorder on Parents in Arab Countries: A Systematic Literature Review. Front Psychol. 2022 Jul 14;13:955442. doi: 10.3389/fpsyg.2022.955442. eCollection 2022.

    PMID: 35911024BACKGROUND
  • Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.

    PMID: 24411117BACKGROUND
  • Fekih-Romdhane F, Fawaz M, Hallit R, Sawma T, Obeid S, Hallit S. Psychometric properties of an Arabic translation of the multidimensional social support scale (MSPSS) in a community sample of adults. BMC Psychiatry. 2023 Jun 14;23(1):432. doi: 10.1186/s12888-023-04937-z.

    PMID: 37316897BACKGROUND
  • Fung K, Lake J, Steel L, Bryce K, Lunsky Y. ACT Processes in Group Intervention for Mothers of Children with Autism Spectrum Disorder. J Autism Dev Disord. 2018 Aug;48(8):2740-2747. doi: 10.1007/s10803-018-3525-x.

    PMID: 29546537BACKGROUND
  • Ebrahim, M. T., & Alothman, A. A. (2022). The reliability and validity of the multidimensional scale of perceived social support (MSPSS) in mothers of children with developmental disabilities in Saudi Arabia. Research in Autism Spectrum Disorders, 92, 101926.

    BACKGROUND
  • Chua JYX, Shorey S. The Effect of Mindfulness-Based and Acceptance Commitment Therapy-Based Interventions to Improve the Mental Well-Being Among Parents of Children with Developmental Disabilities: A Systematic Review and Meta-Analysis. J Autism Dev Disord. 2022 Jun;52(6):2770-2783. doi: 10.1007/s10803-021-04893-1. Epub 2021 Jun 28.

    PMID: 34181139BACKGROUND
  • Chan KKS, Lam CB. 2018. Self-stigma among parents of children with autism spectrum disorder. Research in Autism Spectrum Disorders 48:44-52 DOI 10.1016/j.rasd.2018.01.001.

    BACKGROUND
  • Chan KKS, Lam CB. 2017. Trait mindfulness attenuates the adverse psychological impact of stigma on parents of children with autism spectrum disorder. Mindfulness 8(4):984-994 DOI 10.1007/s12671-016-0675-9.

    BACKGROUND
  • Corti C, Pergolizzi F, Vanzin L, Cargasacchi G, Villa L, Pozzi M, Molteni M. 2018. Acceptance and commitment Therapy-Oriented Parent-Training for parents of children with autism. Journal of Child and Family Studies 27:2887-2900

    BACKGROUND
  • Broady TR, Stoyles GJ, Morse C. Understanding carers' lived experience of stigma: the voice of families with a child on the autism spectrum. Health Soc Care Community. 2017 Jan;25(1):224-233. doi: 10.1111/hsc.12297. Epub 2015 Oct 22.

    PMID: 26494211BACKGROUND
  • Ali AM, Hori H, Kim Y, Kunugi H. The Depression Anxiety Stress Scale 8-Items Expresses Robust Psychometric Properties as an Ideal Shorter Version of the Depression Anxiety Stress Scale 21 Among Healthy Respondents From Three Continents. Front Psychol. 2022 Mar 24;13:799769. doi: 10.3389/fpsyg.2022.799769. eCollection 2022.

    PMID: 35496141BACKGROUND
  • AlBatti TH, Alsaghan LB, Alsharif MF, Alharbi JS, BinOmair AI, Alghurair HA, Aleissa GA, Bashiri FA. Prevalence of autism spectrum disorder among Saudi children between 2 and 4 years old in Riyadh. Asian J Psychiatr. 2022 May;71:103054. doi: 10.1016/j.ajp.2022.103054. Epub 2022 Feb 28.

    PMID: 35248844BACKGROUND
  • Al-Gamal, E., Alhosain, A., Alsunaye, K., Alhujaili, A. D., & Thomas, C. (2019). Levels and predictors of self-stigma among male nursing students in Saudi Arabia. American Journal of Men's Health, 13(5), 1557988319876264.

    BACKGROUND
  • Al-Ghabeesh, S. H., Abu El Haija, A. H., & El-Adwan, R. M. (2021). The Relationship between Cognitive Fusion and Psychological Distress among Parents of Children with Autism Spectrum Disorder. International Journal of Pediatrics, 2021.

    BACKGROUND
  • Al-Zaidy, A., Alqahtani, A. H., Alhazzani, M., & Alqahtani, A. S. (2020). Prevalence of Autism Spectrum Disorder in Saudi Arabia: A systematic review. Journal of Family Medicine and Primary Care, 9(1), 62-67.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderSocial StigmaCaregiver BurdenDepressionAnxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehaviorStress, PsychologicalBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Amani A. Kappi, PhD

    University of Jazan

    PRINCIPAL INVESTIGATOR
  • Warda H. Al Shahat, PhD

    University of Jazan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 13, 2026

Study Start

January 25, 2026

Primary Completion

February 26, 2026

Study Completion

February 26, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations