The Effectiveness of an Autistic-delivered Peer-support Intervention for Autistic Adults: Community Autism Peer Specialist (CAPS) Program

NCT05702658 | Active Not Recruiting DMC

• 2 other identifiers: 22060092901R34MH130830
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

peer support; adult; developmental disabilities; independent living; participation

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

experimental arm

EXPERIMENTAL

Individuals who receive CAPS

Behavioral: CAPS

control

NO INTERVENTION

Individuals who receive treatment as usual

Interventions

CAPS BEHAVIORAL

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

experimental arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Individuals will be asked to self-report their gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent, as assessed by research staff using an active recall method.

Sponsors & Collaborators

• Drexel University: lead
• Temple University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Developmental Disabilities

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 27, 2023
• Study Start: February 9, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)