Building Resilience and Appropriate Independence in Young Adults With Autism

NCT03842332 | Unknown

• 2 other identifiers: P0527544R21MH115375
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in Baseline Employment Status

  Baseline & 3-6 months

Study Arms (2)

Resilience Training

EXPERIMENTAL

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.

Behavioral: Life Skills and Resilience Program

Standard Care

NO INTERVENTION

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

Interventions

Life Skills and Resilience Program BEHAVIORAL

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.

Resilience Training

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Unable to consent
• Wards of the state
• Incarcerated.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator
• Golden Gate Regional Center: collaborator
• The Arc San Francisco: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The Arc

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Megumi Okumura, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project utilizes an intention to treat, wait-list cross over design of individuals who agree to participate.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: February 15, 2019
• Study Start: January 25, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)