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Completed

NCT Number: NCT05944289

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

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.

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Key information

Conditions

Caregiver Stress Behavior Behavioral Symptoms Caregiver Burden Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fielding Graduate University

Santa Barbara, California, 95105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

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

Caregiver Support Group

Behavioral

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

Primary outcomes

  1. Brief Symptom Inventory-18 (BSI-18)

    Time frame: Baseline - prior to intervention particpation

    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

  2. Brief Symptom Inventory-18 (BSI-18)

    Time frame: Post - within two weeks of intervention completion

    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

  3. Brief Symptom Inventory-18 (BSI-18)

    Time frame: Follow-up- completed within 1 month of intervention completion

    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

  4. Perceived Stress Scale - 10 Items (PSS-10)

    Time frame: Baseline - prior to intervention particpation

    10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded

  5. Perceived Stress Scale - 10 Items (PSS-10)

    Time frame: Post - within two weeks of intervention completion

    10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded

  6. Perceived Stress Scale - 10 Items (PSS-10)

    Time frame: Follow-up- completed within 1 month of intervention completion

    10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded

  7. Positive Aspects of Caregiving (PAC)

    Time frame: Baseline - prior to intervention particpation

    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

  8. Positive Aspects of Caregiving (PAC)

    Time frame: Post - within two weeks of intervention completion

    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

  9. Positive Aspects of Caregiving (PAC)

    Time frame: Follow-up- completed within 1 month of intervention completion

    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

  10. Parental Stress Index-Short Form (PSI-SF)

    Time frame: Baseline - prior to intervention particpation

    36-item self-report instrument

  11. Parental Stress Index-Short Form (PSI-SF)

    Time frame: Post - within two weeks of intervention completion

    36-item self-report instrument

  12. Parental Stress Index-Short Form (PSI-SF)

    Time frame: Follow-up- completed within 1 month of intervention completion

    36-item self-report instrument

  13. Self-Compassion Scale - Short Form (SCS-SF)

    Time frame: Baseline - prior to intervention particpation

    12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification

  14. Self-Compassion Scale - Short Form (SCS-SF)

    Time frame: Post - within two weeks of intervention completion

    12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification

  15. Self-Compassion Scale - Short Form (SCS-SF)

    Time frame: Follow-up- completed within 1 month of intervention completion

    12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification

Sponsors and collaborators

Lead sponsor

Fielding Graduate University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 13, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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