Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

11 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Cognitive Fusion
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Amani A. Kappi, PhD, University of Jazan
  • Dyrektor Studium: Warda H. Al Shahat, PhD, University of Jazan

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

25 stycznia 2026

Zakończenie podstawowe (Rzeczywisty)

26 lutego 2026

Ukończenie studiów (Rzeczywisty)

26 lutego 2026

Daty rejestracji na studia

Pierwszy przesłany

29 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj