Building Resilience and Appropriate Independence in Young Adults With Autism

NCT ID: NCT03842332

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This project utilizes an intention to treat, wait-list cross over design of individuals who agree to participate.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Life Skills and Resilience Program

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Golden Gate Regional Center

UNKNOWN

Sponsor Role collaborator

The Arc San Francisco

UNKNOWN

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Megumi Okumura, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Arc

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21MH115375

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P0527544

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motivation for Daily Living Skills
NCT07159308 RECRUITING NA