Pilot Study: Stress Reduction in Caregivers of Children With ASD Using ACT

NCT ID: NCT05944289

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-19

Study Completion Date

2024-01-11

Brief Summary

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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.

Detailed Description

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Conditions

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Caregiver Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to a treatment condition (parent support control group or ACT intervention group). The design of the study will be randomized, two-group mixed model design with 1) a group-based Acceptance and Commitment Therapy (ACT)intervention and 2) a parent support group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACT

ACT Intervention Group

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

a four-week workshop based on the principles and procedures of Acceptance and Commitment Therapy

Support

Control Group - Caregiver support group

Group Type OTHER

Caregiver Support Group

Intervention Type BEHAVIORAL

Caregiver support group to run parallel to the ACT intervention group.

Interventions

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Acceptance and Commitment Therapy

a four-week workshop based on the principles and procedures of Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

Caregiver Support Group

Caregiver support group to run parallel to the ACT intervention group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fielding Graduate University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asimina Lazaridou, Ph.D

Role: STUDY_CHAIR

Fielding Graduate University

Locations

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Fielding Graduate University

Santa Barbara, California, United States

Site Status

Countries

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United States

Other Identifiers

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22-0404

Identifier Type: -

Identifier Source: org_study_id

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