CAPS Program for Autism

(CAPS Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Unable to provide informed consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new peer support service called CAPS, designed to help autistic adults improve their health and well-being. The trial compares those receiving CAPS to those continuing with their usual treatments. It targets autistic adults aged 18-30 who face challenges in major life areas like socializing or work and reside in Philadelphia County. Participants must communicate in English and provide consent. The goal is to determine if the CAPS service is effective, easy to use, and ready for broader testing. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance support services for autistic adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this support service is safe for autistic adults?

Research shows that specific safety information for the CAPS Program for Autism is not yet available. This new support service, designed to help autistic adults, is still in testing. The trial is in an early phase, focusing on understanding how the service works rather than testing its safety in detail.

Without detailed safety information, it's important to note that new treatments often begin with small studies to ensure safety before progressing to larger ones. The CAPS program aims to support autistic adults through peer support, generally considered low-risk compared to medical treatments. However, without specific safety findings, determining its exact tolerance is challenging.

Prospective participants should discuss any concerns with the study team. This conversation will help clarify expectations and ensure the trial aligns with personal comfort levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CAPS Program for Autism because it explores a new approach that differs from traditional behavioral therapies like Applied Behavior Analysis (ABA) and medications such as antipsychotics or stimulants. Unlike these standard treatments, the CAPS program focuses on a comprehensive, personalized strategy that integrates various therapeutic elements tailored to each individual's needs. This innovative method aims to enhance social communication skills and adaptive behaviors in a more holistic way, potentially offering more sustainable improvements in daily functioning for individuals with autism.

What evidence suggests that the CAPS program is effective for autism?

Research has shown that peer support programs led by autistic individuals, such as CAPS, yield promising results in enhancing the well-being of autistic people. Participants in these programs report benefits like increased self-esteem and greater community involvement. In this trial, participants in the experimental arm will receive the CAPS program. Early findings suggest that those in the CAPS program express high satisfaction and experience positive changes. Studies indicate that connecting with peers who share similar experiences can be very beneficial. These results suggest that CAPS could effectively help autistic adults lead more fulfilling lives. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking autistic adults aged 18-30 living in Philadelphia County, who want to improve their social or daily life skills and have a confirmed autism diagnosis. Participants must be able to give informed consent and express challenges in major life areas like social interactions or work.

Inclusion Criteria

Have a diagnosis of autism spectrum disorder confirmed by a licensed healthcare provider

I struggle with daily activities like work, school, or social interactions.

I want to improve my ability in a specific area.

Exclusion Criteria

I am able to understand and remember information to give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of a manual and fidelity tool for the CAPS program to facilitate evaluation and systematic implementation

4-8 weeks

Pilot Randomized Controlled Trial

Conduct a pilot randomized controlled trial to test the feasibility and acceptability of the CAPS intervention

12 months

Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CAPS

Trial Overview The CAPS program is being tested, which is peer support given by individuals with lived experience of autism. The study aims to develop this novel service further and assess its effectiveness through a pilot randomized controlled trial before larger-scale implementation.

How Is the Trial Designed?

Group I: experimental arm Experimental Treatment 1 Intervention

Individuals who receive CAPS

Group II: control Active Control 1 Intervention

Individuals who receive treatment as usual

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Temple University

Collaborator

Trials

321

Recruited

89,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety reporting in this area of research.

Among the studies that did report on participant withdrawal, 10 identified reasons that could be classified as adverse events, suggesting that researchers need to improve their methods for tracking and reporting these occurrences to better inform families and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. Bottema-Beutel, K., Crowley, S., Sandbank, M., et al.[2023]

Risperidone has been found to be effective and safe in treating specific behavioral issues in children with autism spectrum disorder (ASD), such as irritability, aggression, and hyperactivity, based on a review of double-blind, placebo-controlled trials.

However, risperidone does not significantly improve the core symptoms of autism, which include social skill impairments and communication difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of risperidone in children with autism spectrum disorder. Chavez, B., Chavez-Brown, M., Rey, JA.[2013]

The implementation of the ASD Care Pathway (ASD-CP) in a public hospital child psychiatric service led to a 40% reduction in the average length of hospital stays for youth with autism spectrum disorder, from 22.4 days to 13.4 days.

Crisis interventions, such as holds and restraints, decreased by 77% after the ASD-CP was implemented, indicating a potential improvement in the management of patients with ASD, although these results approached statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an Autism Spectrum Disorder Care Pathway Improve Care for Children and Adolescents with ASD in Inpatient Psychiatric Units? Kuriakose, S., Filton, B., Marr, M., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05702658

The Effectiveness of an Autistic-delivered Peer-support ... The proposed study seeks to refine, manualize, and test a pilot autistic peer support program aimed at supporting community participation among autistic young ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9652131/

Autistic-Delivered Peer Support: A Feasibility Study - PMC This study examined characteristics of participants in an autistic-delivered peer support program and reports on use of and satisfaction with the program.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05702658/the-effectiveness-of-an-autistic-delivered-peer-support-intervention-for-autistic-adults-community-autism-peer-specialist-caps-program

Community Autism Peer Specialist (CAPS) Program The second and third aims are to conduct a hybrid type 1 effectiveness-implementation randomized controlled trial with 40 young autistic adults ...

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/13623613251374971

Impact of peer-support programs for individuals with autism Studies reported diverse improvements, including enhanced well-being, self-esteem, and academic performance. Many participants valued connecting ...

5. researchgate.net researchgate.net/publication/373018057_Short_Report_on_Effectiveness_of_an_Autistic-Delivered_Peer_Support_Program_Preliminary_Results

Short Report on Effectiveness of an Autistic-Delivered Peer ... This study examines early outcomes associated with the Community Autism Peer Specialist program (CAPS), which was created in partnership with autistic ...

6. withpower.com withpower.com/trial/phase-autistic-disorder-2023-8b983

CAPS Program for Autism · Info for Participants · Clinical Trial 2025 What safety data exists for the CAPS Program for Autism treatment? The research articles provided do not contain specific safety data for the CAPS Program for ...

7. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/childrens-autism-program-policy-manual.pdf

Children's Autism Program (CAP) Policy Manual autism spectrum disorder. The policy manual is structured to provide contractor staff with information needed to comply with program statute, policy, and rules.

8. fda.gov fda.gov/news-events/press-announcements/fda-takes-action-make-treatment-available-autism-symptoms

FDA Takes Action to Make a Treatment Available for ... The FDA has conducted a systematic analysis of literature published between 2009-2024, including published case reports with patient-level ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4439475/

Complementary and Alternative Therapies for Autism ... There is no conclusive evidence supporting the efficacy of CAM therapies in ASD. Promising results are reported for music therapy, sensory integration therapy, ...