Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

March 20, 2024 updated by: Temple University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Decisional Conflict Scale
Time Frame: Baseline, through intervention completion (up to 3 months)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Multidimensional Scale of Perceived Social Support
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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)
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline, through intervention completion (up to 3 months)
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
Time Frame: Baseline,through intervention completion (up to 3 months)
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
Time Frame: At intervention completion (up to 3 months after baseline)
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
Time Frame: At intervention completion (up to 3 months after baseline)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Temple University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Thomas, Ph.D., Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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