- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513419
The AMOR Method: Resilience Training for Parents of Children With Autism
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Parents eligible to participate include parents: a) English-speaking, b) of a child aged 4:0 to 10:11 years, c) with a previous diagnosis of ASD and evidence of current social impairment (SRS-2) and repetitive behaviors (RBS-R), and d) who are able to consistently participate in sessions. Given budgetary constraints, direct diagnostic testing will not be feasible. Instead, child diagnostic status will be confirmed through review of the child's medical record for evidence that the child previously met ADOS criteria for ASD and shows clinically significant social impairment at baseline (SRS-2 T>65).
Parents who are not eligible to participate include parents: a) with severe psychiatric, genetic, or medical disorder among parents and/or children, b) taking psychiatric medication, and c) with elevated resilience scores at baseline (Total Score >80 on CD-RISC). The DSM-5 CCSM will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders.
Exclusion Criteria:
a) Severe psychiatric, genetic, or medical disorder among parents and/or children, b) parents taking psychiatric medication, and c) parents with elevated resilience scores at baseline (Total Score>80 on CD-RISC). The DSM-5 Cross Cutting Symptom Measure (DSM-5 CCSM) will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders. These families will be referred for behavioral consultation (available in our clinic) and then be reconsidered for group participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AMOR Method
The AMOR Method: The parent resilience training involves a series of eight weekly 90-minute group sessions, as well as three individual sessions.
Group session content includes training in mindfulness, grief and loss processing, acceptance and committed actions, optimistic thinking, and resilience through the use of didactic training, group discussions, and homework assignments.
Individual session content will center on additional and individualized training in grief and loss processing, optimistic thinking, and maintaining resilience over time.
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The parent resilience training involves a series of eight weekly 90-minute group sessions with up to 8 parents of young children with ASD (4- 10:11 years old) per group, as well as three individual sessions.
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NO_INTERVENTION: Wait List
Participants assigned to the waitlist will continue stable treatments and will be offered the opportunity to participate in the treatment after completion of the 8-week trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to week 8
Time Frame: Baseline, week 8
|
No subscales, total score only, 25 items total, 0-4 Likert Score Range: 0-100 Low resilience score (PTSD & grief populations) = 45 or lower; Average/Normal resilience score (general population) = 45-80; High Average/Elevated resilience score (yogi & meditation teachers) = 81-100 Higher total scores reflect higher levels of resilience.
|
Baseline, week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Acceptance and Action Questionnaire-II (AAQ-II) from Baseline to week 8
Time Frame: Baseline, week 8
|
No subscales, total score only, 10 items total (3 items reverse scored) Score Range: 0-70 Low acceptance 0-22, Medium 23-47, High 48-70 Higher total scores reflect higher levels of optimism.
|
Baseline, week 8
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Change in Mindful Attention Awareness Scale (MAAS) from Baseline to week 8
Time Frame: Baseline, week 8
|
No subscales, total score only, 15 items total Score Range: 15-90 Low mindfulness score = 30 or lower; Average/Normal mindfulness score = 30-45-60; High Average/Elevated mindfulness score = 60 or higher Higher total scores reflect higher levels of dispositional mindfulness.
|
Baseline, week 8
|
Change in Life Orientation Test Revised (LOT-R) from Baseline to week 8
Time Frame: Baseline, week 8
|
No subscales, total score only, 10 items total Score Range: 0-24 Low optimism 0-8, Medium/Average Optimism 9-16, High Optimism 17-24 Higher total scores reflect higher levels of optimism.
|
Baseline, week 8
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 45774
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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