Back to resultsUse of Parent Connectors in First Episode Psychosis (FEP)
Primary Purpose
First Episode Psychosis (FEP)
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PPN
CSC Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for First Episode Psychosis (FEP)
Eligibility Criteria
Inclusion Criteria:
- Parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services
Exclusion Criteria:
- NA
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Parent Connectors
Usual Care
Arm Description
trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services
Coordinated Specialty Care (CSC)
Outcomes
Primary Outcome Measures
Family Empowerment Scale (FES)
A 34 item self reported instrument designed to measure empowerment status. The scale measures levels of empowerment, such as family, service system and community, and is rated on a likert scale, scale, ranging from1 (not true at all) to 5 (very true). The FES produces scores for three subscales based on level of empowerment:Family (12 items), Service system (12 items), and Community/ Political (10 items).
Patient Activation Measure (PAM)
100-point quantifiable scale determining patient engagement in healthcare
Secondary Outcome Measures
Full Information
NCT ID
NCT04018521
First Posted
July 9, 2019
Last Updated
March 23, 2022
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04018521
Brief Title
Use of Parent Connectors in First Episode Psychosis (FEP)
Official Title
Use of Parent Connectors in First Episode Psychosis (FEP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
inventional part of the study is registered under NCT05195489
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
February 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study proposes to adapt an evidence based peer parent navigator (PPN) intervention, called Parent Connectors, in which trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newly enrolled youth or young adults (Y/YA) in FEP services. This PPN model will be used to enhance the delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY). This research project has potential to add value to the CSC model through the inclusion of a feasible, low burden intervention that may improve family participation in services and Y/YA outcomes. Using random assignment, this study will examine the feasibility and preliminary impact of an accelerator strategy-the inclusion of peer parent navigators or PPNs-in CSC teams.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis (FEP)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent Connectors
Arm Type
Active Comparator
Arm Description
trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Coordinated Specialty Care (CSC)
Intervention Type
Behavioral
Intervention Name(s)
PPN
Intervention Description
Delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY).
Intervention Type
Behavioral
Intervention Name(s)
CSC Usual Care
Intervention Description
standard of care provided to youth following first episode of psychosis
Primary Outcome Measure Information:
Title
Family Empowerment Scale (FES)
Description
A 34 item self reported instrument designed to measure empowerment status. The scale measures levels of empowerment, such as family, service system and community, and is rated on a likert scale, scale, ranging from1 (not true at all) to 5 (very true). The FES produces scores for three subscales based on level of empowerment:Family (12 items), Service system (12 items), and Community/ Political (10 items).
Time Frame
9 Months
Title
Patient Activation Measure (PAM)
Description
100-point quantifiable scale determining patient engagement in healthcare
Time Frame
9 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services
Exclusion Criteria:
NA
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Parent Connectors in First Episode Psychosis (FEP)
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