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

Caregiver Stress Clinical Trial

Official title:

Acceptance and Commitment Therapy for Stress Reduction in Caregivers of Children With Autism Spectrum Disorder: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944289
• Other study ID #: 22-0404
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2023
• Source: Fielding Graduate University
• Contact: Shannon Harper, MEd, MA, MS
• Phone: 317-331-6574
• Email: slharper[@]email.fielding.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Stress

Intervention

Behavioral:
• Acceptance and Commitment Therapy
a four-week workshop based on the principles and procedures of Acceptance and Commitment Therapy
• Caregiver Support Group
Caregiver support group to run parallel to the ACT intervention group.

Locations

Country	Name	City	State
United States	Fielding Graduate University	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Fielding Graduate University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Parental Stress Index-Short Form (PSI-SF)	36-item self-report instrument	Baseline - prior to intervention particpation
Primary	Parental Stress Index-Short Form (PSI-SF)	36-item self-report instrument	Post - within two weeks of intervention completion
Primary	Parental Stress Index-Short Form (PSI-SF)	36-item self-report instrument	Follow-up- completed within 1 month of intervention completion
Primary	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
Primary	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
Primary	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