Use of Parent Connectors in First Episode Psychosis (FEP)

NCT04018521 | Withdrawn

• 2 other identifiers: 19-0070218-A1-00-007376
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

First Episode Psychosis (FEP)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Parent Connectors

ACTIVE COMPARATOR

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; Behavioral: CSC Usual Care

Usual Care

ACTIVE COMPARATOR

Coordinated Specialty Care (CSC)

Behavioral: CSC Usual Care

Interventions

PPN BEHAVIORAL

Delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY).

Parent Connectors

CSC Usual Care BEHAVIORAL

standard of care provided to youth following first episode of psychosis

Parent Connectors; Usual Care

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: August 1, 2021
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share