Clinical trial NCT05944289: Pilot Study: Stress Reduction in Caregivers of Children With ASD Using ACT
Official title: Acceptance and Commitment Therapy for Stress Reduction in Caregivers of Children With Autism Spectrum Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Stress
Keywords: Caregivers of children with autism and stress
Lead sponsor: Fielding Graduate University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brief Symptom Inventory-18 (BSI-18)
timeFrame: Baseline - prior to intervention particpation
measure: Brief Symptom Inventory-18 (BSI-18)
timeFrame: Post - within two weeks of intervention completion
measure: Brief Symptom Inventory-18 (BSI-18)
timeFrame: Follow-up- completed within 1 month of intervention completion
measure: Perceived Stress Scale - 10 Items (PSS-10)
timeFrame: Baseline - prior to intervention particpation
measure: Perceived Stress Scale - 10 Items (PSS-10)
timeFrame: Post - within two weeks of intervention completion
measure: Perceived Stress Scale - 10 Items (PSS-10)
timeFrame: Follow-up- completed within 1 month of intervention completion
measure: Positive Aspects of Caregiving (PAC)
timeFrame: Baseline - prior to intervention particpation
measure: Positive Aspects of Caregiving (PAC)
timeFrame: Post - within two weeks of intervention completion
measure: Positive Aspects of Caregiving (PAC)
timeFrame: Follow-up- completed within 1 month of intervention completion
measure: Parental Stress Index-Short Form (PSI-SF)
timeFrame: Baseline - prior to intervention particpation
measure: Parental Stress Index-Short Form (PSI-SF)
timeFrame: Post - within two weeks of intervention completion
measure: Parental Stress Index-Short Form (PSI-SF)
timeFrame: Follow-up- completed within 1 month of intervention completion
measure: Self-Compassion Scale - Short Form (SCS-SF)
timeFrame: Baseline - prior to intervention particpation
measure: Self-Compassion Scale - Short Form (SCS-SF)
timeFrame: Post - within two weeks of intervention completion
measure: Self-Compassion Scale - Short Form (SCS-SF)
timeFrame: Follow-up- completed within 1 month of intervention completion
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Fielding Graduate University
state: California
Study officials:
affiliation: Fielding Graduate University
name: Asimina Lazaridou, Ph.D
role: STUDY_CHAIR
References: