Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

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

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders
• Intervention / Treatment: Behavioral: Peer-Delivered Decision Support Intervention

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Thomas, Ph.D.; Phone Number: 215-204-1699; Email: tug66715@temple.edu

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Child and Family Focus (On My Way Program)
    • Danville, Pennsylvania, United States, 17821
      • CMSU Behavioral Health & Developmental Services
    • Philadelphia, Pennsylvania, United States, 19150
      • Horizon House

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Peer-Delivered Decision Support Intervention

Behavioral: Peer-Delivered Decision Support Intervention; An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Decisional Conflict Scale	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.	Baseline, through intervention completion (up to 3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Multidimensional Scale of Perceived Social Support	Change was calculated as the Multidimensional Scale of Perceived Social Support value at intervention completion minus the value at baseline. Full scale scores range from 12-84, with higher scores indicating a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Control Preference Scale	Change was calculated as the Control Preference Scale value at intervention completion minus the value at baseline. Scores on the Control Preference Scale range from 1-11; higher scores indicate less of a preference for control in decision-making.	Baseline, through intervention completion (up to 3 months)
Change in Perceived Involvement in Care Scale	Change was calculated as the Perceived Involvement in Care Scale value at intervention completion minus the value at baseline. Scores on the Perceived Involvement in Care Scale range from 0-13, with higher scores indicating a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Birchwood Insight Scale	Change was calculated as the Birchwood Insight Scale value at intervention completion minus the value at baseline. Scores on the Birchwood Insight Scale range from 0-12, with higher scores indicating a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Internalized Stigma of Mental Illness Scale	Change was calculated as the Internalized Stigma of Mental Illness Scale value at intervention completion minus the value at baseline. Scores on the Internalized Stigma of Mental Illness Scale range from 1-4, with higher scores indicating a worst outcome.	Baseline, through intervention completion (up to 3 months)
Change in Empowerment Scale	Change was calculated as the Empowerment Scale value at intervention completion minus the value at baseline. Scores on the Empowerment Scale range from 28-112, with higher scores indicating a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Decision-Self-Efficacy Scale	Change was calculated as the Decision Self-Efficacy Scale value at intervention completion minus the value at baseline. Scores on the Decision Self-Efficacy Scale range from 0-100, with higher scores indicating a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Recovery Assessment Scale	Change was calculated as the Recovery Assessment Scale value at intervention completion minus the value at baseline. Scores on the Recovery Assessment Scale range from 24-120, with higher scores indicating a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Number of Outpatient Mental Health Visits (Service Use and Resources Form)	Change was calculated as the number of outpatient mental health visits at intervention completion minus the number of outpatient mental health visits at baseline according to the Service Use and Resources Form. The minimum score is 0; there is no maximum score. Higher scores indicate greater service utilization.	Baseline, through intervention completion (up to 3 months)
Change in Brief Adherence Rating Scale	Change was calculated as the Brief Adherence Rating Scale value at intervention completion minus the value at baseline. Scores on Brief Adherence Rating Scale range from 0-100, with higher scores indicating a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Intent to Attend Measure	Change was calculated as the Intent to Attend Measure value at intervention completion minus the value at baseline. Scores range from 0-18. Higher scores indicate a better outcome.	Baseline, through intervention completion (up to 3 months)
Change in Service Engagement Scale	Change was calculated as the Service Engagement Scale value at intervention completion minus the value at baseline. Scores on the Service Engagement Scale range from 0-42, with higher scores indicating a worst outcome.	Baseline, through intervention completion (up to 3 months)
Change in Working Alliance Inventory	Change was calculated as the Working Alliance Inventory value at intervention completion minus the value at baseline. Scores on Working Alliance Inventory range from 36-252, with higher scores indicating a better outcome.	Baseline,through intervention completion (up to 3 months)
Satisfaction with Decision Value	Scores on the Satisfaction with Decision Scale range from 6 to 30, with higher scores indicating a better outcome. These are the values at intervention completion.	At intervention completion (up to 3 months after baseline)
Intentional Peer Support Value	Scores on the Intentional Peer Support scale range from 1 to 5 with higher scores indicating a better outcome. These are the values at intervention completion.	At intervention completion (up to 3 months after baseline)

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Elizabeth Thomas, Ph.D., Temple University

Publications and helpful links

General Publications

• Thomas EC, Suarez J, Lucksted A, Siminoff LA, Hurford I, Dixon LB, O'Connell M, Penn DL, Salzer MS. Facilitating treatment engagement for early psychosis through peer-delivered decision support: intervention development and protocol for pilot evaluation. Pilot Feasibility Stud. 2021 Oct 24;7(1):189. doi: 10.1186/s40814-021-00927-8.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Decision Support Techniques, Young Adult
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 261047; K08MH116101 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No