Facilitating Engagement in Evidence-Based Treatment for Early Psychosis
Primary Purpose
Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Delivered Decision Support Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Psychotic Disorders focused on measuring Decision Support Techniques, Young Adult
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
Sites / Locations
- CMSU Behavioral Health & Developmental Services
- Horizon House
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peer-Delivered Decision Support Intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in Decisional Conflict Scale
Change was calculated as the Decisional Conflict Scale value at intervention completion minus the value at baseline. Scores on the Decisional Conflict Scale range from 0-100, with higher scores indicating a worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT04532034
First Posted
July 21, 2020
Last Updated
July 24, 2023
Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04532034
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Decision Support Techniques, Young Adult
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer-Delivered Decision Support Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Peer-Delivered Decision Support Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Decisional Conflict Scale
Description
Change was calculated as the Decisional Conflict Scale value at intervention completion minus the value at baseline. Scores on the Decisional Conflict Scale range from 0-100, with higher scores indicating a worse outcome.
Time Frame
Baseline, through intervention completion (up to 3 months)
Other Pre-specified Outcome Measures:
Title
Change in Multidimensional Scale of Perceived Social Support
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Control Preference Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Perceived Involvement in Care Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Birchwood Insight Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Internalized Stigma of Mental Illness Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Empowerment Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Decision-Self-Efficacy Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Recovery Assessment Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Number of Outpatient Mental Health Visits (Service Use and Resources Form)
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Brief Adherence Rating Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Intent to Attend Measure
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Service Engagement Scale
Description
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.
Time Frame
Baseline, through intervention completion (up to 3 months)
Title
Change in Working Alliance Inventory
Description
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.
Time Frame
Baseline,through intervention completion (up to 3 months)
Title
Satisfaction with Decision Value
Description
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.
Time Frame
At intervention completion (up to 3 months after baseline)
Title
Intentional Peer Support Value
Description
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.
Time Frame
At intervention completion (up to 3 months after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Thomas, Ph.D.
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMSU Behavioral Health & Developmental Services
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
Facility Name
Horizon House
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19150
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34689830
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.
Results Reference
derived
Learn more about this trial
Facilitating Engagement in Evidence-Based Treatment for Early Psychosis
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