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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05195489
Other study ID # 21-01486
Secondary ID P50MH113662
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 7, 2022
Est. completion date October 31, 2024

Study information

Verified date April 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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