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| ID | Type | Description | Link |
|---|---|---|---|
| JU-NUR-ACT-2026 | Other Identifier | Jazan Cluster Health |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Caregivers with physical and mental disabilities were excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Amani A. Kappi, PhD | University of Jazan | Principal Investigator |
| Warda H. Al Shahat, PhD | University of Jazan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jazan Health Cluster | Jizan | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 20362379 |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D057545 | Social Stigma |
| D000084802 | Caregiver Burden |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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. |
| Background | 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. |
| 31711591 | 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. |
| Background | 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. |
| 26659549 | 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. |
| 35911024 | Background | 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. |
| 24411117 | Background | 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. |
| 37316897 | Background | 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. |
| 29546537 | Background | 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. |
| Background | 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. |
| 34181139 | 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. |
| Background | 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 |
| 26494211 | 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. |
| 35496141 | Background | 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. |
| 35248844 | Background | 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. |
| Background | 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. |
| D001519 | Behavior |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |