Pilot Study: Stress Reduction in Caregivers of Children With ASD Using ACT
Acceptance and Commitment Therapy for Stress Reduction in Caregivers of Children With Autism Spectrum Disorder: A Pilot Study
1 other identifier
interventional
60
1 country
1
Brief Summary
Parents/Caregivers of children with autism need psychological flexibility and self-efficacy for the ACT program to be effective. This study will compare intervention differences between groups. Repeated measures will be given three times (pre-intervention, post-intervention, and follow-up) to an ACT intervention group and a support group (control). The purpose of the present study is to compare the effects of a brief ACT-based workshop for parents of children with autism with a concurrent parent support control group using a variety of self-report measures addressing psychological flexibility, depression, thought suppression, cognitive fusion, positive aspects of caregiving, stress, self-compassion, and valued living.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2023
CompletedFirst Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2024
CompletedMarch 13, 2025
March 1, 2025
6 months
May 30, 2023
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Brief Symptom Inventory-18 (BSI-18)
18-item self-administered measure that provides information on participants' overall psychological distress and Global Severity Index, as well as scales of somatization, depression, and anxiety
Baseline - prior to intervention particpation
Brief Symptom Inventory-18 (BSI-18)
18-item self-administered measure that provides information on participants' overall psychological distress and Global Severity Index, as well as scales of somatization, depression, and anxiety
Post - within two weeks of intervention completion
Brief Symptom Inventory-18 (BSI-18)
18-item self-administered measure that provides information on participants' overall psychological distress and Global Severity Index, as well as scales of somatization, depression, and anxiety
Follow-up- completed within 1 month of intervention completion
Perceived Stress Scale - 10 Items (PSS-10)
10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded
Baseline - prior to intervention particpation
Perceived Stress Scale - 10 Items (PSS-10)
10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded
Post - within two weeks of intervention completion
Perceived Stress Scale - 10 Items (PSS-10)
10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded
Follow-up- completed within 1 month of intervention completion
Positive Aspects of Caregiving (PAC)
nine-item pencil-and-paper instrument that assesses caregivers' subjectively perceived gains from desirable aspects of or positive affective returns from providing care for their loved one
Baseline - prior to intervention particpation
Positive Aspects of Caregiving (PAC)
nine-item pencil-and-paper instrument that assesses caregivers' subjectively perceived gains from desirable aspects of or positive affective returns from providing care for their loved one
Post - within two weeks of intervention completion
Positive Aspects of Caregiving (PAC)
nine-item pencil-and-paper instrument that assesses caregivers' subjectively perceived gains from desirable aspects of or positive affective returns from providing care for their loved one
Follow-up- completed within 1 month of intervention completion
Parental Stress Index-Short Form (PSI-SF)
36-item self-report instrument
Baseline - prior to intervention particpation
Parental Stress Index-Short Form (PSI-SF)
36-item self-report instrument
Post - within two weeks of intervention completion
Parental Stress Index-Short Form (PSI-SF)
36-item self-report instrument
Follow-up- completed within 1 month of intervention completion
Self-Compassion Scale - Short Form (SCS-SF)
12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification
Baseline - prior to intervention particpation
Self-Compassion Scale - Short Form (SCS-SF)
12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification
Post - within two weeks of intervention completion
Self-Compassion Scale - Short Form (SCS-SF)
12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification
Follow-up- completed within 1 month of intervention completion
Study Arms (2)
ACT
EXPERIMENTALACT Intervention Group
Support
OTHERControl Group - Caregiver support group
Interventions
a four-week workshop based on the principles and procedures of Acceptance and Commitment Therapy
Caregiver support group to run parallel to the ACT intervention group.
Eligibility Criteria
You may qualify if:
- Individuals will be eligible for entry if (1) they are the biological or adoptive parent (and primary caregiver) of a child with a diagnosis of an autism spectrum disorder, (2) the child is 2-17 years of age inclusive, (3) speak English, and (4) they plan to live in the area for at least six months and (5) present proof of vaccination and (6) agree to masking and social distancing during the in-person workshop.
You may not qualify if:
- Individuals will be excluded from the study if (1) they are involved in a concurrent clinical trial of psychosocial interventions for parents/caregivers or (2) they (or their child/spouse) indicate during telephone screening or on the demographics questionnaire active major medical issues such as cancer, organ transplant, or severe mental health disorders that prevent active participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fielding Graduate University
Santa Barbara, California, 95105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Asimina Lazaridou, Ph.D
Fielding Graduate University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2023
First Posted
July 13, 2023
Study Start
March 19, 2023
Primary Completion
September 11, 2023
Study Completion
January 11, 2024
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
In the following standard research practices, the data will never contain identifying or potentially identifying information. The participant identities and responses to assessments will be downloaded from Qualtrics and stored only on Shannon Harper's password-protected computer. The data will be saved on a password-protected computer for 10 years after publication, and then the data will be destroyed.