Autism Spectrum DisorderNCT03842332
Building Resilience and Appropriate Independence in Young Adults With Autism
A study testing Life Skills and Resilience Program in people with Autism Spectrum Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study evaluates the effects of a 12-week life-skills resilience curriculum for young adults with autism. The project utilizes a cohort single arm design. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Life Skills and Resilience Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking
- Unable to consent
- Wards of the state
- Incarcerated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience in Action: Building Resilience and Appropriate Independence in Young Adults With Autism
This study evaluates the effects of a 12-week life-skills resilience curriculum for young adults with autism. The project utilizes a cohort single arm design.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Life Skills and Resilience Program
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Skills and Resilience ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Life Skills and Resilience Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience Scale
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
Measured: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline measure)
McMaster Family Assessment Device (FAD), General Functioning Subscale
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 in an individual item or above indicates problematic family functioning.
- 12 questions score range 12-48
Measured: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
PROMIS: Self Efficacy Scale
PROMIS® Self-Efficacy score A person's belief in his/her capacity to manage functioning and have control over meaningful events. The higher the score, the higher the capacity to manage functioning and control over meaningful events.
- Raw scores reported (ranging from 10 to 50)
- A higher PROMIS represents greater satisfaction with self-efficacy
Measured: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
Pediatric Quality of Life
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
Measured: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
Satisfaction With Social Roles (v2.0)
PROMIS Satisfaction with Social Roles (v2.0)
- Measures satisfaction with performing one's usual social roles (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.
Measured: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
Secondary outcomes (1)
Employment/Volunteer Status
Percentage of study participants employed or volunteering. Please note that work was measured during the COVID-19 pandemic, which started right after the study began.
Measured: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Jan 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This project utilizes an intention to treat study of a single arm to pilot test a resilience framework on 30 clients with autism
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Golden Gate Regional Center, The Arc San Francisco, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Megumi Okumura, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842332
- Sponsor's protocol ID
- P0527544
- Other IDs
- R21MH115375
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2018
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okumura MJ, Selling SK, Uba A, Martin-Herz SP, Seretan HH, Rosene L, Cohen J, Tebb KP, Rehm RS. Framework for developing self-actualization skills in young adults with autism. Health Care Transit. 2024 Jan 12;2:100038. doi: 10.1016/j.hctj.2023.100038. eCollection 2024.
PubMed 39712615
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience in Action: Building Resilience and Appropriate Independence in Young Adults With Autism
- ClinicalTrials.gov ID
- NCT03842332
- Acronym / sponsor ID
- P0527544
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Golden Gate Regional Center, The Arc San Francisco, National Institute of Mental Health (NIMH)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of a 12-week life-skills resilience curriculum for young adults with autism. The project utilizes a cohort single arm design.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This project utilizes an intention to treat study of a single arm to pilot test a resilience framework on 30 clients with autism
| Arm | Type | Receives |
|---|---|---|
| Resilience Training | Experimental | Behavioral: Life Skills and Resilience ProgramThis 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Non-English speaking
- Unable to consent
- Wards of the state
- Incarcerated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Skills and Resilience ProgramThe 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. | Behavioural | Resilience Training |
Primary outcome
Resilience Scale
Time frame: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline measure)
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
McMaster Family Assessment Device (FAD), General Functioning Subscale
Time frame: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
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 in an individual item or above indicates problematic family functioning. * 12 questions score range 12-48
PROMIS: Self Efficacy Scale
Time frame: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
PROMIS® Self-Efficacy score A person's belief in his/her capacity to manage functioning and have control over meaningful events. The higher the score, the higher the capacity to manage functioning and control over meaningful events. * Raw scores reported (ranging from 10 to 50) * A higher PROMIS represents greater satisfaction with self-efficacy
Pediatric Quality of Life
Time frame: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
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
Satisfaction With Social Roles (v2.0)
Time frame: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
PROMIS Satisfaction with Social Roles (v2.0) * Measures satisfaction with performing one's usual social roles (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.
1 secondary outcome
Employment/Volunteer Status
Time frame: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39712615Okumura MJ, Selling SK, Uba A, Martin-Herz SP, Seretan HH, Rosene L, Cohen J, Tebb KP, Rehm RS. Framework for developing self-actualization skills in young adults with autism. Health Care Transit. 2024 Jan 12;2:100038. doi: 10.1016/j.hctj.2023.100038. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megumi Okumura, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Skills and Resilience Program in people with Autism Spectrum Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience Scale (time frame: Assessed at baseline and 3-6 months post completion (up to 9 months post baseline measure)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.