AutismCAPSNCT05702658
The Effectiveness of Community Autism Peer Specialist (CAPS) Program
A study testing CAPS in people with Autism, run by Drexel University at 1 site in United States.
Trial summary
The number of autistic adults reached 5.4 million in the United States in 2017 and is projected to continue to rise, but evidence-based practices to optimize their health and well-being are limited and poor outcomes are common. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- CAPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years old
- Have a diagnosis of autism spectrum disorder that is confirmed by a licensed healthcare provider
- Self-reported challenges in one or more major life areas (i.e., social, school, work, self-maintenance)
- Express a desire to enhance functioning in one of these areas
- Reside in Philadelphia County
- Be able to communicate in English (i.e., understand at a basic conversational level and communicate verbally or using technology or other approaches). This is required because the intervention will be delivered in English, and the interactions between the peer specialists and participants will be in English.
- Be able to provide informed consent
Who cannot join
- Unable to provide informed consent, as assessed by research staff using an active recall method.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Autistic-delivered Peer-support Intervention for Autistic Adults: Community Autism Peer Specialist (CAPS) Program
The number of autistic adults reached 5.4 million in the United States in 2017 and is projected to continue to rise, but evidence-based practices to optimize their health and well-being are limited and poor outcomes are common. This study will leverage existing infrastructure to finalize the development of a novel support service provided by peers with lived experience, incorporating input from autistic peer specialists, autism researchers, peer support researchers, and experts in peer support training. Investigators will then conduct a pilot randomized controlled trial to examine the effectiveness of the service while also examining the feasibility, acceptability, and implementation procedures in preparation for future large-scale testing and dissemination.
Read the detailed description
Approximately 5.4 million adults in the United States (1 in 45) are believed to have autism spectrum disorder (ASD), but there is a lack of services available to support them in reaching their full potential. Although typically conceptualized as a childhood disorder, ASD-related service needs persist into adulthood. The core social and communication impairments of ASD, reported difficulties with change, and a high rate of co-occurring mental health conditions often result in limited participation in major life areas that are determinants of health, including social and community participation, employment, housing, and transportation. The transition to adulthood is not only associated with developmental challenges, but also a "services cliff" whereby supports and services that were previously available through the education system are no longer available. Peer-delivered interventions have emerged as a potent, evidence-based modality for enhancing outcomes among other clinical populations, such as adults with serious mental illnesses, with effectiveness in enhancing social networks, empowering participants, reducing the use of inpatient services, and increasing life satisfaction. At present, there is limited research on the effectiveness of autistic-led peer support interventions, especially those that target broad aspects of community functioning. The proposed study seeks to refine, manualize, and test a pilot autistic peer support program aimed at supporting community participation among autistic young adults, with the goal of preparing it for large-scale testing and future dissemination and sustainability. The first aim of this proposal is to enhance the structure of a pilot autistic-peer delivered intervention (Community Autism Peer Specialists, or CAPS) that is currently in use as a Medicaid-reimbursed service in Philadelphia. This will include developing a manual and fidelity tool to facilitate evaluation and systematic implementation. The second and third aims are to conduct a hybrid type 1 effectiveness-implementation randomized controlled trial with 40 young autistic adults to test the feasibility and acceptability of the intervention and research procedures, while also examining proposed target mechanisms of action (e.g., self-efficacy, working alliance, perceived social support) and clinical outcomes such as community participation, loneliness, and resilience. This work will gather additional evidence and implementation information to support a fully-powered R01- funded clinical trial. The proposed efforts will involve substantial engagement of a diverse group of autistic adults in all phases along with multiple community partners, including a Medicaid payer. The project has tremendous potential to expand service options for autistic adults and is uniquely poised to have broad, scalable impact.
- Conditions
- Autism
- Being tested
- CAPS
- Keywords
- peer support, adult, developmental disabilities, independent living, participation
- Medical subject headings
- Autistic Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPSBehavioural
Community Autism Peer Support is a one-to-one autistic-delivered peer support, community-based intervention focused on independent living and participation.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Individuals who receive CAPS Receives: Behavioral: CAPS |
| control | No intervention | Individuals who receive treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general Self-Efficacy
General Self-Efficacy Scale (GSES) is a 10-item scale that will be used to measure an individual's perceptions regarding their ability to manage novel situations. All 10 items are scored using a Likert rating scale, ranging from 1 (not at all true) to 4 (exactly true).The total score ranges from 10 to 40. A higher score indicates better self-efficacy.
Measured: Baseline, month 3, month 12
Change in Internalized Stigma
The Brief version of the Internalized Stigma of Mental Illness (ISMI-10) scale will be adapted to determine the extent to which autistic individuals have accepted perceptions from others about their ability to function successfully in the community. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores range from 10-40, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Measured: Baseline, month 3, month 12
Change in coping skills
The Brief COPE is a questionnaire to assess the usual coping strategies. A total of 28 items are scored on from 1=not at all to 4 = a lot, with minimum score of 28 and maximum score of 112. A higher score reflect a higher level of coping skills
Measured: Baseline, month 3, month 12
Change in self-identity
The adapted Questionnaire on Disability Identity and Opportunity (QDIO) uses 30 questions to measure disability participation and orientation, using a five-point Likert scale where 1 = strongly disagree and 5 = strongly agree. Total scores range from 30 to 150, with higher score reflecting a more positive self-identity
Measured: Baseline, month 3, month 12
Change in social support
The Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support and informational support item banks will be used to measure social support. A total of 8 items are scored on a 5-point response scale. Scores can range from 8 to 40 (a higher score means higher reported support).
Measured: Baseline, month 3, month 12
Change in unmet needs
A modified version of the Camberwell Assessment of Need will be used to assess unmet needs in 23 life domains, including housing, taking care of one's home, autism information and treatment, psychological distress, social life, intimate relationships, and other areas. The total scores range from 0 to 23, with higher score indicating more unmet needs
Measured: Baseline, month 3, month 12
Change in social functioning
The Social Responsiveness Scale, 2nd edition (SRS-2) is among the most well-validated and frequently used measures of ASD symptomatology. The SRS-2 provides a continuous measure of social ability. Scores range from 30 to >= 90, with higher scores indicating greater social impairment.
Measured: Baseline, month 3, month 12
Change in Cognitive Flexibility
The Shift scale from the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) will be used to measure cognitive flexibility. Participants rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience within the last month. The sum of 6 items yields the raw score (range: 6-18). A lower score represents a better outcome.
Measured: Baseline, month 3, month 12
Change in Loneliness
The University of California Los Angeles Loneliness Scale, Version 3 is a 20-item scale that assesses feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.
Measured: Baseline, month 3, month 12
Change in Purpose in Life
The PROMIS Meaning and Purpose item bank that consists of 8 items will be used. The response options range from "not at all" to "very much," yielding a raw score from 8 to 40. A higher score indicates a higher level of purpose in life.
Measured: Baseline, month 3, month 12
Change in Resilience
The Connor-Davidson Resilience Scale - 10 (CD-RISC) is the most frequently used instrument to measure resilience. The measure consists of 10 items using a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all of the time). The scale measures how the participant felt over the past month. The questionnaire produces an overall resilience score that ranges from 0-40, with higher scores representing greater resilience.
Measured: Baseline, month 3, month 12
Change in Hope
The Adult Hope Scale assesses belief in one's own ability to pursue desired goals and employ strategies needed to achieve the goals. A total of 12 items are scored on a scale from 1=Definitely False to 8 =Definitely True. Total scores range from 12 to 96, with a higher score reflecting a higher level of perceived hope.
Measured: Baseline, month 3, month 12
Changes in Community Participation
We will use a modified version of the Temple University Community Participation Measure (TUCP) to measure community participation. A total of 27 items measure the total days of participation (ranging from 0 - 810) and total participation areas (ranging from 0-27), with higher scores indicating higher levels of community participation.
Measured: Baseline, month 12
Changes in Quality of Life
WHOQOL-BREF evaluates both objective and subjective aspects of quality of life. A total 26 item produces four domain scores: physical, psychological, social relationships and environment domain (Likert type scale ranging from 1- strongly disagree to 5 - strongly agree). The total scores range from 26 to 130, with a higher score reflecting a higher level of quality of life.
Measured: Baseline, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start9 Feb 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lindsay Shea, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702658
- Sponsor's protocol ID
- 2206009290
- Other IDs
- 1R34MH130830
- Acronym
- CAPS
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Autistic-delivered Peer-support Intervention for Autistic Adults: Community Autism Peer Specialist (CAPS) Program
- ClinicalTrials.gov ID
- NCT05702658
- Acronym / sponsor ID
- CAPS / 2206009290
- Conditions
- Autism
- Keywords
- peer support, adult, developmental disabilities, independent living, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Temple University, National Institute of Mental Health (NIMH)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of autistic adults reached 5.4 million in the United States in 2017 and is projected to continue to rise, but evidence-based practices to optimize their health and well-being are limited and poor outcomes are common. This study will leverage existing infrastructure to finalize the development of a novel support service provided by peers with lived experience, incorporating input from autistic peer specialists, autism researchers, peer support researchers, and experts in peer support training. Investigators will then conduct a pilot randomized controlled trial to examine the effectiveness of the service while also examining the feasibility, acceptability, and implementation procedures in preparation for future large-scale testing and dissemination.
Detailed description
Approximately 5.4 million adults in the United States (1 in 45) are believed to have autism spectrum disorder (ASD), but there is a lack of services available to support them in reaching their full potential. Although typically conceptualized as a childhood disorder, ASD-related service needs persist into adulthood. The core social and communication impairments of ASD, reported difficulties with change, and a high rate of co-occurring mental health conditions often result in limited participation in major life areas that are determinants of health, including social and community participation, employment, housing, and transportation. The transition to adulthood is not only associated with developmental challenges, but also a "services cliff" whereby supports and services that were previously available through the education system are no longer available. Peer-delivered interventions have emerged as a potent, evidence-based modality for enhancing outcomes among other clinical populations, such as adults with serious mental illnesses, with effectiveness in enhancing social networks, empowering participants, reducing the use of inpatient services, and increasing life satisfaction. At present, there is limited research on the effectiveness of autistic-led peer support interventions, especially those that target broad aspects of community functioning. The proposed study seeks to refine, manualize, and test a pilot autistic peer support program aimed at supporting community participation among autistic young adults, with the goal of preparing it for large-scale testing and future dissemination and sustainability. The first aim of this proposal is to enhance the structure of a pilot autistic-peer delivered intervention (Community Autism Peer Specialists, or CAPS) that is currently in use as a Medicaid-reimbursed service in Philadelphia. This will include developing a manual and fidelity tool to facilitate evaluation and systematic implementation. The second and third aims are to conduct a hybrid type 1 effectiveness-implementation randomized controlled trial with 40 young autistic adults to test the feasibility and acceptability of the intervention and research procedures, while also examining proposed target mechanisms of action (e.g., self-efficacy, working alliance, perceived social support) and clinical outcomes such as community participation, loneliness, and resilience. This work will gather additional evidence and implementation information to support a fully-powered R01- funded clinical trial. The proposed efforts will involve substantial engagement of a diverse group of autistic adults in all phases along with multiple community partners, including a Medicaid payer. The project has tremendous potential to expand service options for autistic adults and is uniquely poised to have broad, scalable impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Behavioral: CAPSIndividuals who receive CAPS |
| control | No intervention | –Individuals who receive treatment as usual |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-30 years old
- Have a diagnosis of autism spectrum disorder that is confirmed by a licensed healthcare provider
- Self-reported challenges in one or more major life areas (i.e., social, school, work, self-maintenance)
- Express a desire to enhance functioning in one of these areas
- Reside in Philadelphia County
Key exclusion criteria (1 listed)
- Unable to provide informed consent, as assessed by research staff using an active recall method.
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 |
|---|---|---|
| CAPSCommunity Autism Peer Support is a one-to-one autistic-delivered peer support, community-based intervention focused on independent living and participation. | Behavioural | experimental arm |
Primary outcome
Change in general Self-Efficacy
Time frame: Baseline, month 3, month 12
General Self-Efficacy Scale (GSES) is a 10-item scale that will be used to measure an individual's perceptions regarding their ability to manage novel situations. All 10 items are scored using a Likert rating scale, ranging from 1 (not at all true) to 4 (exactly true).The total score ranges from 10 to 40. A higher score indicates better self-efficacy.
Change in Internalized Stigma
Time frame: Baseline, month 3, month 12
The Brief version of the Internalized Stigma of Mental Illness (ISMI-10) scale will be adapted to determine the extent to which autistic individuals have accepted perceptions from others about their ability to function successfully in the community. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores range from 10-40, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Change in coping skills
Time frame: Baseline, month 3, month 12
The Brief COPE is a questionnaire to assess the usual coping strategies. A total of 28 items are scored on from 1=not at all to 4 = a lot, with minimum score of 28 and maximum score of 112. A higher score reflect a higher level of coping skills
Change in self-identity
Time frame: Baseline, month 3, month 12
The adapted Questionnaire on Disability Identity and Opportunity (QDIO) uses 30 questions to measure disability participation and orientation, using a five-point Likert scale where 1 = strongly disagree and 5 = strongly agree. Total scores range from 30 to 150, with higher score reflecting a more positive self-identity
Change in social support
Time frame: Baseline, month 3, month 12
The Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support and informational support item banks will be used to measure social support. A total of 8 items are scored on a 5-point response scale. Scores can range from 8 to 40 (a higher score means higher reported support).
Change in unmet needs
Time frame: Baseline, month 3, month 12
A modified version of the Camberwell Assessment of Need will be used to assess unmet needs in 23 life domains, including housing, taking care of one's home, autism information and treatment, psychological distress, social life, intimate relationships, and other areas. The total scores range from 0 to 23, with higher score indicating more unmet needs
Change in social functioning
Time frame: Baseline, month 3, month 12
The Social Responsiveness Scale, 2nd edition (SRS-2) is among the most well-validated and frequently used measures of ASD symptomatology. The SRS-2 provides a continuous measure of social ability. Scores range from 30 to >= 90, with higher scores indicating greater social impairment.
Change in Cognitive Flexibility
Time frame: Baseline, month 3, month 12
The Shift scale from the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) will be used to measure cognitive flexibility. Participants rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience within the last month. The sum of 6 items yields the raw score (range: 6-18). A lower score represents a better outcome.
Change in Loneliness
Time frame: Baseline, month 3, month 12
The University of California Los Angeles Loneliness Scale, Version 3 is a 20-item scale that assesses feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.
Change in Purpose in Life
Time frame: Baseline, month 3, month 12
The PROMIS Meaning and Purpose item bank that consists of 8 items will be used. The response options range from "not at all" to "very much," yielding a raw score from 8 to 40. A higher score indicates a higher level of purpose in life.
Change in Resilience
Time frame: Baseline, month 3, month 12
The Connor-Davidson Resilience Scale - 10 (CD-RISC) is the most frequently used instrument to measure resilience. The measure consists of 10 items using a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all of the time). The scale measures how the participant felt over the past month. The questionnaire produces an overall resilience score that ranges from 0-40, with higher scores representing greater resilience.
Change in Hope
Time frame: Baseline, month 3, month 12
The Adult Hope Scale assesses belief in one's own ability to pursue desired goals and employ strategies needed to achieve the goals. A total of 12 items are scored on a scale from 1=Definitely False to 8 =Definitely True. Total scores range from 12 to 96, with a higher score reflecting a higher level of perceived hope.
Changes in Community Participation
Time frame: Baseline, month 12
We will use a modified version of the Temple University Community Participation Measure (TUCP) to measure community participation. A total of 27 items measure the total days of participation (ranging from 0 - 810) and total participation areas (ranging from 0-27), with higher scores indicating higher levels of community participation.
Changes in Quality of Life
Time frame: Baseline, month 12
WHOQOL-BREF evaluates both objective and subjective aspects of quality of life. A total 26 item produces four domain scores: physical, psychological, social relationships and environment domain (Likert type scale ranging from 1- strongly disagree to 5 - strongly agree). The total scores range from 26 to 130, with a higher score reflecting a higher level of quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Data will be shared via the NIMH Data Archive
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPS in people with Autism, run by Drexel University 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 7 inclusion and 1 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 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in general Self-Efficacy (time frame: Baseline, month 3, month 12). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.