Autism Spectrum Disorder Clinical Trial
Official title:
The AMOR Method: Resilience Training for Parents of Children With Autism
| NCT number | NCT03513419 |
| Other study ID # | 45774 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 25, 2018 |
| Est. completion date | February 29, 2020 |
| Verified date | May 2021 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
We will evaluate whether a resilience training program which includes group and individual parent training will be effective in improving optimism and resiliency in parents of young children with autism spectrum disorders (ASD). By observing the level of parent optimism and resiliency before and after intervention, we will be able to determine whether the intervention is effective in improving parent resilience.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | February 29, 2020 |
| Est. primary completion date | February 29, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to 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 | |
| Secondary | Change in Acceptance and Action Questionnaire-II (AAQ-II) from Baseline to 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 | |
| Secondary | Change in Mindful Attention Awareness Scale (MAAS) from Baseline to 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 | |
| Secondary | Change in Life Orientation Test Revised (LOT-R) from Baseline to 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 |
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