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Clinical Trials/NCT04532034
NCT04532034
Completed
N/A

Facilitating Emerging Adults Engagement in Evidenced-Based Treatment for Early Psychosis Through Peer-Delivered Decision Support

Temple University3 sites in 1 country12 target enrollmentSeptember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychotic Disorders
Sponsor
Temple University
Enrollment
12
Locations
3
Primary Endpoint
Change in Decisional Conflict Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this mixed methods study is to evaluate a peer-delivered decision support intervention with emerging adults newly enrolled in an early intervention program, also known as coordinated specialty care (CSC). It is hypothesized that participants will experience a reduction in decision-making needs after participating in the intervention, and that study and intervention procedures will demonstrate feasibility and acceptability.

Detailed Description

The overarching goal of this study is to pilot test a peer-delivered decision support intervention (in the form of decision coaching) that is designed to enhance emerging adults' treatment decision-making and service engagement after enrollment in a coordinated specialty care (CSC) program. Based on an experimental therapeutics approach, this mixed methods pilot trial will assess feasibility, acceptability, and the intervention's potential impact on key decision-making needs (i.e., decision-making targets). We will track feasibility data related to study and intervention procedures, and collect acceptability and outcome data from 20 emerging adults who will participate in the intervention after enrollment in the CSC program. Quantitative analysis related to decision-making targets will provide preliminary evidence regarding whether the intervention impacts these targets, while qualitative analysis will explain how it may do so. Merged results from these two sets of data will inform intervention refinement by providing a nuanced understanding of the intervention's potential to engage decision-making targets from the perspective of emerging adults.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18-30 years of age
  • Experiencing early psychosis,defined as psychosis lasting 18 months or less between the time when threshold symptom criteria were reached (as determined by the admitting CSC program assessor) and the date of CSC program enrollment
  • Able to speak/understand English
  • Able to provide informed consent as assessed by research staff
  • Enrolled in the CSC program for any period of time

Exclusion Criteria

  • having a legal guardian
  • Diagnosis of dementia, delirium, or intellectual disability as determined by the admitting CSC program psychiatrist

Outcomes

Primary Outcomes

Change in Decisional Conflict Scale

Time Frame: Baseline, through intervention completion (up to 3 months)

Change was calculated as the Decisional Conflict Scale value at intervention completion minus the value at baseline. Total scores on the Decisional Conflict Scale are calculated as: (sum of all items scores / the total number of items) x 25. For this study, 9 items were included. Scores on the Decisional Conflict Scale range from 0-100, with higher scores indicating a worse outcome.

Study Sites (3)

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