- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06492434
Enhancing Community Participation Through Peer-Delivered Decision Support
December 21, 2025 updated by: Temple University
Enhancing Community Participation Outcomes Among Young Adults With Serious Mental Illnesses Through Peer-Delivered Decision Support
The purpose of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illness (SMI).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illnesses (SMI).
We will use a single-group, pre-post, convergent mixed methods design to explore implementation and whether and how the intervention impacts decision-making and community participation outcomes.
We will aim to recruit 40 participants in this intervention study.
This design will enable us to link themes regarding participants' experience of the intervention with quantitative measures of decision-making and community participation.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19122
- Temple University
-
-
Vermont
-
Brattleboro, Vermont, United States, 05302
- Copeland Center for Wellness and Recovery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-30 years of age;
- Experiencing a SMI, as determined by: (a) self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder, and (b) self-reported current or past functional impairment due to experiencing mental health challenges in one or more major life areas (i.e., work school, social activities)
- Able to identify at least 2 areas of community participation that individuals want to be doing more in in the next 6 months
- Current sufficiency of community participation (i.e., number of important participation areas done enough / number of important participation areas) of 50% or less.
Exclusion Criteria:
- Unable to provide informed consent, as assessed by research staff using an active recall method
- limited ability to act on decisions due to self-reported legal, residential, or guardianship restrictions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer decision coaching arm
All participants will engage in the Peer Decision Coaching intervention.
|
Peer Decision Coaching is a brief, personalized intervention grounded in evidence-based decision- and peer support principles.
During the intervention, a trained peer specialist supports the young person in identifying a decision related to community participation that they need to make, such as whether to work or go to school, helping them address decision-making needs, and assisting them with developing and implementing a decision-making plan.
Ultimately, the intervention aims to support young people in pursuing their community participation interests and goals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in decisional conflict scale
Time Frame: Baseline, through intervention completion (up to 3 months)
|
The Factors Contributing to Uncertainty subscale of the Decisional Conflict Scale measures decision-making needs.
Possible scores range from 0 to 36, with higher scores indicating a worse outcome.
|
Baseline, through intervention completion (up to 3 months)
|
|
Change in decision self-efficacy scale
Time Frame: Baseline, through intervention completion (up to 3 months)
|
The Decision Self-Efficacy Scale assesses confidence in making an informed choice.
Possible scores range from 0 to 44, with higher scores indicating a better outcome.
|
Baseline, through intervention completion (up to 3 months)
|
|
Decision-making behaviors at post-intervention
Time Frame: Post-intervention (up to 3 months post-baseline)
|
Number of behaviors (range: 0-6) endorsed on Decision-Making Behaviors scale at post-intervention.
|
Post-intervention (up to 3 months post-baseline)
|
|
Decision Satisfaction Scale Score at post-intervention
Time Frame: Post-intervention (up to 3 months post-baseline)
|
The Decision Satisfaction Scale assesses a person's satisfaction with a health decision.
Possible scores range from 6-30, with higher scores indicating a better outcome.
|
Post-intervention (up to 3 months post-baseline)
|
|
Change in Temple University Community Participation Measure (sufficiency)
Time Frame: Baseline, through intervention completion (up to 3 months)
|
Sufficiency scores on the Temple University Community Participation Measure assess how satisfied individuals are with their amount of community participation in areas that are important to them.
Possible scores range from 0-100, with higher scores indicating a better outcome.
|
Baseline, through intervention completion (up to 3 months)
|
|
Change in Temple University Community Participation Measure (breadth ratio)
Time Frame: Baseline, through intervention completion (up to 3 months)
|
Breadth ratio scores on the Temple University Participation Measure assess breadth of participation in areas considered important to a person.
Possible scores range from 0-100, with higher scores indicating a better outcome.
|
Baseline, through intervention completion (up to 3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Thomas, PhD, Temple University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Actual)
August 31, 2025
Study Completion (Actual)
August 31, 2025
Study Registration Dates
First Submitted
July 2, 2024
First Submitted That Met QC Criteria
July 2, 2024
First Posted (Actual)
July 9, 2024
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 21, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 270034
- 90IFRE0068 (Other Grant/Funding Number: NIDILRR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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