Clinical trial NCT03842332: Building Resilience and Appropriate Independence in Young Adults With Autism
Official title: Resilience in Action: Building Resilience and Appropriate Independence in Young Adults With Autism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Golden Gate Regional Center
name: The Arc San Francisco
name: National Institute of Mental Health (NIMH)
First posted: 2019-02-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This project utilizes an intention to treat, wait-list cross over design of individuals who agree to participate.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of a 12-week life-skills resilience curriculum for young adults with autism. The project utilizes a wait-list crossover design and compares the intervention to standard care.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Baseline Resilience at 3-6 months
timeFrame: Baseline & 3-6 months
measure: Change in Baseline General Family Functioning at 3-6 months
timeFrame: Baseline & 3-6 months
measure: Change in Baseline Self Efficacy at 3-6 months
timeFrame: Baseline & 3-6 months
measure: Change in Baseline Pediatric Quality of Life at 3-6 months
timeFrame: Baseline & 3-6 months
measure: Change in Baseline Satisfaction with Social Roles at 3-6 months and Activities (v2.0)
timeFrame: Baseline & 3-6 months
Secondary outcomes:
measure: Change in Baseline Employment Status
timeFrame: Baseline & 3-6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: The Arc
state: California
Study officials:
affiliation: University of California, San Francisco
name: Megumi Okumura, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: