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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05702658
Other study ID # 2206009290
Secondary ID 1R34MH130830
Status Recruiting
Phase N/A
First received
Last updated
Start date February 9, 2023
Est. completion date May 31, 2024

Study information

Verified date September 2023
Source Drexel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Unable to provide informed consent, as assessed by research staff using an active recall method.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CAPS
Community Autism Peer Support is a one-to-one autistic-delivered peer support, community-based intervention focused on independent living and participation.

Locations

Country Name City State
United States Drexel University Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Drexel University National Institute of Mental Health (NIMH), Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, month 3, month 12
Primary 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. Baseline, month 3, month 12
Primary 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 Baseline, month 3, month 12
Primary 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 Baseline, month 3, month 12
Primary 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). Baseline, month 3, month 12
Primary 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 Baseline, month 3, month 12
Primary 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. Baseline, month 3, month 12
Primary 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. Baseline, month 3, month 12
Primary 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. Baseline, month 3, month 12
Primary 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. Baseline, month 3, month 12
Primary 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. Baseline, month 3, month 12
Primary 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. Baseline, month 3, month 12
Primary 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. Baseline, month 12
Primary 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. Baseline, month 12
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