NCT04532034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

July 21, 2020

Results QC Date

March 20, 2024

Last Update Submit

March 20, 2024

Conditions

Psychotic Disorders

Keywords

Decision Support Techniques, Young Adult

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Peer-Delivered Decision Support Intervention

EXPERIMENTAL
Behavioral: Peer-Delivered Decision Support Intervention

Interventions

Peer-Delivered Decision Support InterventionBEHAVIORAL

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.

Peer-Delivered Decision Support Intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Child and Family Focus (On My Way Program)

Broomall, Pennsylvania, 19008, United States

Location

CMSU Behavioral Health & Developmental Services

Danville, Pennsylvania, 17821, United States

Location

Horizon House

Philadelphia, Pennsylvania, 19150, United States

Location

Related Publications (2)

  • Thomas EC, Lucksted A, Siminoff LA, Hurford I, O'Connell M, Penn DL, Casey I, Smith M, Suarez J, Salzer MS. Case Study Analysis of a Decision Coaching Intervention for Young Adults with Early Psychosis. Community Ment Health J. 2025 Jul;61(5):874-889. doi: 10.1007/s10597-024-01425-w. Epub 2025 Jan 3.

    PMID: 39746883DERIVED

  • 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.

    PMID: 34689830DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Elizabeth THomas
Organization
Temple University
tug66715@temple.edu
215-204-1699

Study Officials

  • Elizabeth Thomas, Ph.D.

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

August 31, 2020

Study Start

September 1, 2020

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 17, 2024

Results First Posted

April 17, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)