Examining the Impact of Family Connectors

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05195489

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

21.8

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Stress Syndrome	Other: Family Connectors	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Examining the Impact of Family Connectors

Actual Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Kimberly Hoagwood, PhD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05195489

Other Study ID Numbers:

21-01486
P50MH113662

First Posted:

Jan 19, 2022

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 8, 2022