Use of Parent Connectors in First Episode Psychosis (FEP)

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.

Study Overview

• Status: Withdrawn
• Conditions: First Episode Psychosis (FEP)
• Intervention / Treatment: Behavioral: PPN; Behavioral: CSC Usual Care

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parent Connectors; 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	Behavioral: PPN; Delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY).; Behavioral: CSC Usual Care; standard of care provided to youth following first episode of psychosis
Active Comparator: Usual Care; Coordinated Specialty Care (CSC)	Behavioral: CSC Usual Care; standard of care provided to youth following first episode of psychosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	9 Months
Patient Activation Measure (PAM)	100-point quantifiable scale determining patient engagement in healthcare	9 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 19-00702; 18-A1-00-007376 (Other Grant/Funding Number: NATIONAL INSTITUTE OF MENTAL HEALTH (NIM))

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