Examining the Impact of Family Connectors

The purpose of this study is to understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults.

Study Overview

• Status: Active, not recruiting
• Conditions: Caregiver Stress Syndrome
• Intervention / Treatment: Other: Family Connectors

Detailed Description

The study objectives are to examine the association between involvement in Family Connectors, a manualized peer-to-peer support and education program for family members of adolescents or young adults with symptoms of first episode psychosis, and feelings of empowerment, self-efficacy and social support.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Acri, PhD; Phone Number: 203-675-4691; Email: Mary.Acri@nyulangone.org
• Study Contact Backup: Name: Nicole Davies; Phone Number: 202-669-4540; Email: nicole.davies@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking, due to the study materials not being validated in other languages.
• 18 years of age or older,
• Family member of adolescents/young adults with first episode psychosis who participated in OnTrackNY.

Exclusion Criteria:

• Does not provide informed consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Intervention; Family members participate in Connectors by phone and receive a packet of resources	Other: Family Connectors; The Family Connectors Program is a manualized program that uses a time-limited parent-to parent (i.e. peer parent) support and education program delivered by phone to families of youth with serious mental health difficulties, assisting family members in becoming fully engaged with provider teams who coordinate and provide care. Family Connectors is delivered weekly by phone over the course of between three and six months.
No Intervention: Comparison; Family members receive a pack of resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived social support	Self-reported questionnaire assessing the social support perceived in people who participate in the Family connector program compared to those who do not.	Baseline Visit, One Month Visit, 7 Month Post Visit
Change in lower caregiver strain	Self-reported questionnaire assessing the level of caregiver strain in people who participate in the Family connector program compared to those who do not.	Baseline Visit, One Month Visit, 7 Month Post Visit
Change in perceived self-efficacy	Self-reported questionnaire that assesses the perceived self-efficacy in people who participate in the Family connector program compared to those who do not.	Baseline Visit, One Month Visit, 7 Month Post Visit

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kimberly Hoagwood, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21-01486; P50MH113662 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No