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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
The AMOR Method
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.

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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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