Examining the Impact of Family Connectors

NCT05195489 | Completed Results DMC

• 2 other identifiers: 21-01486P50MH113662
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver Stress Syndrome

Outcome Measures

Primary Outcomes (3)

• Change in Perceived Social Support

  Perceived social support is measured by a 13-item self-reported questionnaire. The subject is asked to rate each statement about social support on a scale of 1-7 (1=very strongly disagree, 2=strongly disagree, 3=disagree, 4=neither agree nor disagree, 5=agree, 6=strongly agree, 7=very strongly agree). Scores range from 13-91. Higher scores indicate stronger social support.

  Month 1, Month 7

• Change in Caregiver Strain

  Caregiver strain is measured by a 10-tiem self-reported questionnaire. The subject is asked to rate each statement relating to caregiver strain on a scale of 1-5 (1=not at all, 2=a little, 3=somewhat, 4=Quite a bit, 5=very much). Scores range from 10-50, with higher scores indicating high caregiver strain.

  Month 1, Month 7

• Change in Perceived Self-efficacy

  Perceived self-efficacy is measured by a 7-tiem self-reported questionnaire. The subject is asked to rate each statement on a scale of 1-5 (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Scores range from 7-35, with higher scores indicating greater perceived self-efficacy.

  Month 1, Month 7

Study Arms (2)

Active Intervention

EXPERIMENTAL

Family members participate in Connectors by phone and receive a packet of resources

Other: Family Connectors

Comparison

NO INTERVENTION

Family members receive a pack of resources

Interventions

Family Connectors OTHER

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.

Active Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Does not provide informed consent.

Sponsors & Collaborators

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

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Results Point of Contact

• Title: Kimberly Hoagwood, PhD
• Organization: NYU Langone Health

Kimberly.Hoagwood@nyulangone.org

240-401-4289

Study Officials

• Kimberly Hoagwood, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 19, 2022
• Study Start: March 7, 2022
• Primary Completion: October 31, 2024
• Study Completion: November 11, 2024
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: The investigator who proposed to use the data. Researchers who provide a methodologically sound proposal.

Locations

US (1)