Clinical trial NCT04532034: Facilitating Engagement in Evidence-Based Treatment for Early Psychosis
Official title: Facilitating Emerging Adults Engagement in Evidenced-Based Treatment for Early Psychosis Through Peer-Delivered Decision Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Decision Support Techniques, Young Adult
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Decisional Conflict Scale
timeFrame: Baseline, through intervention completion (up to 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Broomall
country: United States
facility: Child and Family Focus (On My Way Program)
state: Pennsylvania
city: Danville
country: United States
facility: CMSU Behavioral Health & Developmental Services
state: Pennsylvania
city: Philadelphia
country: United States
facility: Horizon House
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Elizabeth Thomas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.