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Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

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ClinicalTrials.gov Identifier: NCT04532034
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Behavioral: Peer-Delivered Decision Support Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Facilitating Emerging Adults Engagement in Evidenced-Based Treatment for Early Psychosis Through Peer-Delivered Decision Support
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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. Scores on the Decisional Conflict Scale range from 0-100, with higher scores indicating a worse outcome.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-25 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532034


Contacts
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Contact: Elizabeth Thomas, Ph.D. 215-204-1699 tug66715@temple.edu

Locations
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United States, Pennsylvania
CMSU Behavioral Health & Developmental Services Recruiting
Danville, Pennsylvania, United States, 17821
Contact: Mary Lyn Cadman         
Horizon House Not yet recruiting
Philadelphia, Pennsylvania, United States, 19150
Contact: Marie Wenzel         
Sponsors and Collaborators
Temple University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Elizabeth Thomas, Ph.D. Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04532034    
Other Study ID Numbers: 261047
K08MH116101 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple University:
Decision Support Techniques, Young Adult
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders