Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

Not Applicable

Completed

• Conditions: Psychotic Disorders
• Interventions: Behavioral: Peer-Delivered Decision Support Intervention

• Registration Number: NCT04532034
• Lead Sponsor: Temple University

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-31
• Study Start: 2020-09-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2024-03
• Results First Submitted: 2024-03-20
• Results First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Results First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peer-Delivered Decision Support Intervention	Peer-Delivered Decision Support Intervention	-

Primary Outcome Measures

Name	Time	Method
Change in Decisional Conflict Scale	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.

Trial Locations

Locations (3)

Child and Family Focus (On My Way Program); 🇺🇸 Broomall, Pennsylvania, United States

CMSU Behavioral Health & Developmental Services; 🇺🇸 Danville, Pennsylvania, United States

Horizon House; 🇺🇸 Philadelphia, Pennsylvania, United States