Use of Parent Connectors in First Episode Psychosis (FEP)

First Episode Psychosis (FEP) Clinical Trial

Official title:

Use of Parent Connectors in First Episode Psychosis (FEP)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04018521
• Other study ID #: 19-00702
• Secondary ID: 18-A1-00-007376
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: February 23, 2022

Study information

• Verified date: March 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• First Episode Psychosis (FEP)
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• PPN
Delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY).
• CSC Usual Care
standard of care provided to youth following first episode of psychosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient Activation Measure (PAM)	100-point quantifiable scale determining patient engagement in healthcare	9 Months