Caregiver StressNCT05944289
Pilot Study: Stress Reduction in Caregivers of Children With ASD Using ACT
A study testing Acceptance and Commitment Therapy and Caregiver Support Group in people with Caregiver Stress, run by Fielding Graduate University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress
- What is being tested?
- Acceptance and Commitment Therapy and Caregiver Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2023to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fielding Graduate University
Santa Barbara, California, 95105
About this study
Official title: Acceptance and Commitment Therapy for Stress Reduction in Caregivers of Children With Autism Spectrum Disorder: A Pilot Study
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.
- Conditions
- Caregiver Stress
- Being tested
- Acceptance and Commitment Therapy, Caregiver Support Group
- Keywords
- Caregivers of children with autism and stress
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
a four-week workshop based on the principles and procedures of Acceptance and Commitment Therapy
Caregiver Support GroupBehavioural
Caregiver support group to run parallel to the ACT intervention group.
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | ACT Intervention Group Receives: Behavioral: Acceptance and Commitment Therapy |
| Support | Other | Control Group - Caregiver support group Receives: Behavioral: Caregiver Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up- completed within 1 month of intervention completion
Parental Stress Index-Short Form (PSI-SF)
36-item self-report instrument
Measured: Baseline - prior to intervention particpation
Parental Stress Index-Short Form (PSI-SF)
36-item self-report instrument
Measured: Post - within two weeks of intervention completion
Parental Stress Index-Short Form (PSI-SF)
36-item self-report instrument
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up- completed within 1 month of intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start19 Mar 2023
- Primary completion11 Sep 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fielding Graduate University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asimina Lazaridou, Ph.D, Study chair, Fielding Graduate University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944289
- Sponsor's protocol ID
- 22-0404
- Status last verified
- Mar 2025
- First submitted
- 30 May 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the following standard research practices, the data will never contain identifying or potentially identifying information. The participant identities and responses to assessments will be downloaded from Qualtrics and stored only on Shannon Harper's password-protected computer. The data will be saved on a password-protected computer for 10 years after publication, and then the data will be destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Stress Reduction in Caregivers of Children With Autism Spectrum Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT05944289
- Acronym / sponsor ID
- 22-0404
- Conditions
- Caregiver Stress
- Keywords
- Caregivers of children with autism and stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fielding Graduate UniversityUniversity, hospital or other
- Study start
- 19 Mar 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: Acceptance and Commitment TherapyACT Intervention Group |
| Support | Other | Behavioral: Caregiver Support GroupControl Group - Caregiver support group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapya four-week workshop based on the principles and procedures of Acceptance and Commitment Therapy | Behavioural | ACT |
| Caregiver Support GroupCaregiver support group to run parallel to the ACT intervention group. | Behavioural | Support |
Primary outcome
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
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
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
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
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
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
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
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
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
Parental Stress Index-Short Form (PSI-SF)
Time frame: Baseline - prior to intervention particpation
36-item self-report instrument
Parental Stress Index-Short Form (PSI-SF)
Time frame: Post - within two weeks of intervention completion
36-item self-report instrument
Parental Stress Index-Short Form (PSI-SF)
Time frame: Follow-up- completed within 1 month of intervention completion
36-item self-report instrument
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No. In the following standard research practices, the data will never contain identifying or potentially identifying information. The participant identities and responses to assessments will be downloaded from Qualtrics and stored only on Shannon Harper's password-protected computer. The data will be saved on a password-protected computer for 10 years after publication, and then the data will be destroyed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asimina Lazaridou, Ph.D study chair
Fielding Graduate University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy and Caregiver Support Group in people with Caregiver Stress, run by Fielding Graduate University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Symptom Inventory-18 (BSI-18) (time frame: Baseline - prior to intervention particpation). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.