- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842332
Building Resilience and Appropriate Independence in Young Adults With Autism
Resilience in Action: Building Resilience and Appropriate Independence in Young Adults With Autism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As young adults with autism spectrum disorder (YAASD) transition out of the academic supports provided by school, these young adults experience a degradation of social skills over time. This has led to poor academic, educational and health outcomes. YAASD require continuous and ongoing skill development in order to maximize their potential; however, there are few services available to adults with autism to develop and maintain their skills. While interventions exist in early childhood, mid-childhood and adolescence, few programs have been focused on the young adult with autism. Resilience in Action (RiA), is a research study, performed and delivered in the community setting, which seeks to develop supports to address the 'adult world' needs of young adults with autism exiting out of secondary education.
The investigators propose to develop this program through three specific aims. In the first aim, the investigators propose in-depth interviews with adults with autism and/or their families and service providers to better understand barriers and facilitators to "adult living" after graduating out of the school system. In the second aim, the investigators will use the information gained from Aim 1 to develop a 12-week curriculum integrating a resilience framework and methodologies into a community adult life skills program for persons with disabilities. A trained transition curriculum expert who had developed transition curriculum for youth with autism spectrum disorder in our local school district will assist in this "adult" curriculum to fill gaps that exist in the school district curriculum. As part of the infrastructure and support for this pilot, the investigators will generate a protocol for the participant's existing case manager to help support youth and families after the curriculum is completed. The third aim is to then pilot test RiA on 30 young adults with autism who have recently graduated from the secondary education system. Through an iterative program evaluation, the investigators will further hone the intervention and adapt the program to different levels of disability and learning styles. The investigators will measure characteristics of those who were successfully engaged in the program and measure outcomes such as socialization, quality of life, vocational/social activities and self-efficacy. Through this research the investigators will have developed a final protocol for a resiliency course to be tested in a larger clinical trial to see how this type of curriculum can improve longer term social and health outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94103
- The Arc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Moderate to high functioning autism spectrum disorder, defined as an SRS T-score less than 75
- Participants must be able to participate in a one hour class with nine other participants and be able to interact with participants and the teacher without support.
- Completing the high school transition program or have exited the school system within the last three years
Exclusion Criteria:
- Non-English speaking
- Unable to consent
- Wards of the state
- Incarcerated.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resilience Training
This group will participate in the 12 week Life Skills and Resilience Program that includes vocational skills and adult skills important for an adult in society.
Participants will also receive standard case management plus resiliency-focused support to encourage family and young adult interaction with professionals and peers.
Case managers will then utilize a resiliency framework for their interaction with the participant.
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The 12 week life skills course includes resiliency modules that complement the strengths of participants as they progress toward the development and achievement of personal goals.
The first module of the intervention engages youth through a caring/supportive relationship that sets these expectations.
Activities are designed to support youth in identifying their existing strengths/skills.
The second module explores, with youth, how they can apply and build upon their strengths/skills in the pursuit of self-generated goals.
The third module is dedicated to building upon key problem solving skills that are especially important for young adults with autism, including conflict resolution and the management of stressors.
The fourth module builds leadership capacity and self-advocacy skills.
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No Intervention: Standard Care
This group will receive case management referral to community training programs when requested by family, or need (as identified by case worker).
Standard case management includes intake includes housing counseling, case management with mental health and behavioral services, and referral to day programs as needed and identified by case management
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Baseline Resilience at 3-6 months
Time Frame: Baseline & 3-6 months
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Resilience Scale (RS) developed by Wagnild and Young (1990)
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Baseline & 3-6 months
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Change in Baseline General Family Functioning at 3-6 months
Time Frame: Baseline & 3-6 months
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McMaster Family Assessment Device (FAD), General Functioning Subscale
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Baseline & 3-6 months
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Change in Baseline Self Efficacy at 3-6 months
Time Frame: Baseline & 3-6 months
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PROMIS® A person's belief in his/her capacity to manage functioning and have control over meaningful events.
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Baseline & 3-6 months
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Change in Baseline Pediatric Quality of Life at 3-6 months
Time Frame: Baseline & 3-6 months
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Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales
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Baseline & 3-6 months
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Change in Baseline Satisfaction with Social Roles at 3-6 months and Activities (v2.0)
Time Frame: Baseline & 3-6 months
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PROMIS Satisfaction with Social Roles and Activities
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Baseline & 3-6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Baseline Employment Status
Time Frame: Baseline & 3-6 months
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Percentage of study participants employed
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Baseline & 3-6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Megumi Okumura, MD, MAS, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- P0527544
- R21MH115375 (U.S. NIH Grant/Contract)
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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