Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT05702658
Brief 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. 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:
NCT05702658
Study Brief:
Protocol Section:
NCT05702658