Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

NCT ID: NCT04532034

Last Updated: 2024-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Psychotic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Peer-Delivered Decision Support Intervention

Group Type EXPERIMENTAL

Peer-Delivered Decision Support Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Thomas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Child and Family Focus (On My Way Program)

Broomall, Pennsylvania, United States

Site Status

CMSU Behavioral Health & Developmental Services

Danville, Pennsylvania, United States

Site Status

Horizon House

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39746883 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34689830 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K08MH116101

Identifier Type: NIH

Identifier Source: secondary_id

View Link

261047

Identifier Type: -

Identifier Source: org_study_id

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