Building Resilience and Appropriate Independence in Young Adults With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Resilience in Action: Building Resilience and Appropriate Independence in Young Adults With Autism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03842332
• Other study ID #: P0527544
• Secondary ID: R21MH115375
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Life Skills and Resilience Program
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.

Locations

Country	Name	City	State
United States	The Arc	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Golden Gate Regional Center, National Institute of Mental Health (NIMH), National Institutes of Health (NIH), The Arc San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Resilience at 3-6 months	Resilience Scale (RS) developed by Wagnild and Young (1990); Personal competence and acceptance of self and life, which measures the construct of resilience.; Adapted for 2nd and 5th grade reading level; Possible scores range from 25 to 175 with higher scores reflecting higher resilience	Baseline & 3-6 months
Primary	Change in Baseline General Family Functioning at 3-6 months	McMaster Family Assessment Device (FAD), General Functioning Subscale; The General Functioning Subscale ranges from 1 to 4 with higher scores indicating worse levels of family functioning.; A score of 2.00 or above indicates problematic family functioning.	Baseline & 3-6 months
Primary	Change in Baseline Self Efficacy at 3-6 months	PROMIS® A person's belief in his/her capacity to manage functioning and have control over meaningful events.	Baseline & 3-6 months
Primary	Change in Baseline Pediatric Quality of Life at 3-6 months	Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales; Validated quality of life measure that has been developed across different developmental ages and adults; Scale ranges from 0 to 100 and higher scores indicate better Health-Related Quality of Life; Four sub-scales include Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning; Total Scale Score is the mean computed as the sum of all the items over the number of items answered on all the Scales	Baseline & 3-6 months
Primary	Change in Baseline Satisfaction with Social Roles at 3-6 months and Activities (v2.0)	PROMIS Satisfaction with Social Roles and Activities; Measures satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities"); Raw scores (ranging from 6 to 40) are converted to T-scores with a mean of 50 and standard deviation of 10; A higher PROMIS T-score represents greater satisfaction with social roles and activities.	Baseline & 3-6 months
Secondary	Change in Baseline Employment Status	Percentage of study participants employed	Baseline & 3-6 months