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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the CAPS treatment for autism?

The CAPS treatment for autism may be similar to the Comprehensive Autism Program (CAP), which showed small positive impacts on young students' language and social skills. Additionally, the ASD Care Pathway (ASD-CP) improved outcomes in psychiatric care for children with autism, suggesting that structured, autism-specific interventions can be beneficial. ^{1 2 3 4 5}

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 Autism treatment. ^{6 7 8 9 10}

Eligibility Criteria

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

Be able to provide informed consent

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

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

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does an Autism Spectrum Disorder Care Pathway Improve Care for Children and Adolescents with ASD in Inpatient Psychiatric Units? [2018]

2. Poland pubmed.ncbi.nlm.nih.gov

National Professional Development Center on Autism Spectrum Disorders (NPDC) model - an integrated model of evidence-based practices for autism spectrum disorder. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The Autism Impact Measure (AIM): Meaningful Change Thresholds and Core Symptom Changes Over One Year from an Online Survey in the U.S. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Choosing Performance-Based Outcome Measures of Daily Living Skills and Socialization for Clinical Trials in Autistic Children. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Defining the hidden evidence in autism research. Forty per cent of rigorously designed clinical trials remain unpublished - a cross-sectional analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Role of risperidone in children with autism spectrum disorder. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Developmental regression and autism reported to the Vaccine Adverse Event Reporting System. [2007]

9. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Epidemiologic Patterns of Autism Spectrum Disorder in Pediatric Inpatients in the United States, 1997-2019. [2023]