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

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.

Study Overview

• Status: Completed
• Conditions: Caregiver Stress
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Behavioral: Caregiver Support Group

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 95105
      • Fielding Graduate University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT; ACT Intervention Group	Behavioral: Acceptance and Commitment Therapy; a four-week workshop based on the principles and procedures of Acceptance and Commitment Therapy
Other: Support; Control Group - Caregiver support group	Behavioral: Caregiver Support Group; Caregiver support group to run parallel to the ACT intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fielding Graduate University
• Investigators: Study Chair: Asimina Lazaridou, Ph.D, Fielding Graduate University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2023
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Caregivers of children with autism and stress
• Other Study ID Numbers: 22-0404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No