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Clinical Trials/NCT06492434
NCT06492434
Completed
N/A

Enhancing Community Participation Outcomes Among Young Adults With Serious Mental Illnesses Through Peer-Delivered Decision Support

Temple University2 sites in 1 country16 target enrollmentJuly 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe Mental Disorder
Sponsor
Temple University
Enrollment
16
Locations
2
Primary Endpoint
Change in Temple University Community Participation Measure (sufficiency)
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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).

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
August 31, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Study Sites (2)

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