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

Study Overview
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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.

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

Conditions
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Caregiver Stress

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy
* Behavioral: Caregiver Support Group


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers of children with autism and stress