- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464162
OnTrackNY With the Option of Social Network Meetings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project aims to expand the role of family engagement and support within the OnTrackNY model by offering a new service, Social Network Meetings. The study team will offer Social Network Meetings to individuals enrolled in the OnTrackNY@MHA program as an additional service option. This option will be completely voluntary and available for a 12 month period. Participant entrance into the study will be staggered with no more than approximately 5 individuals in the Social Network group and no more than 5 individuals not in the Social Network group enrolled each month. Participants will choose which group they would like to be in, if any. Data will be collected for all participants, both those participating and not participating in the Social Network Meetings upon entering the study and then once every three months and at the end of their time in the study. For all participants, the study will end after 6 months of participation.
Meetings may occur as often as 3 times a week when there is a crisis or more commonly would occur once every other week. These meetings will last between 60 and 90 minutes and will take place for however long the clients and their social networks would like within the project period.
Study aims are:
- To determine the extent to which clients and their social networks find the Social Network meetings acceptable and beneficial.
- To compare outcomes (family functioning, recovery) of individuals participating in Social Network meetings to those not participating.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Yonkers, New York, United States, 10701
- MHA of Westchester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Subject Population 1: OnTrackNY MHA Client- Social Network Meeting Group (ages 16-30)
Inclusion Criteria:
- Ages 16-30
- Currently enrolled, clinically stable, English speaking clients in the OnTrackNY program at MHA Westchester determined my client roster for MHA Westchester program and clinical judgment
- Willingness to participate in Social Network meetings determined by self-report as asked by clinician
- Willingness to complete brief baseline and quarterly assessments determined by self-report as asked by clinician
Exclusion Criteria:
- Anyone who the OnTrackNY team determines is clinically unstable determined by clinician assessment
- Clients who are unwilling to participate in Social Network meetings determined by self-report
Subject Population 2: OnTrackNY MHA Client- No Social Network Meeting Group (ages 16-30)
Inclusion Criteria
- Ages 16-30
- Currently enrolled clients in the OnTrackNY program at MHA Westchester determined by MHA Westchester Client Roster for OnTrackNY
Exclusion Criteria:
- Anyone who the OnTrackNY team determines is clinically unstable determined by clinician assessment
Subject Population 3: Social Network Member (ages 18+)
Inclusion Criteria:
- Must be 18 years or older
- English speaking member of social network (i.e., biological or chosen family member/s) of a currently enrolled client in the OnTrackNY program at MHA Westchester who has agreed to participate in the study determined by client self-report
- Willingness to complete brief baseline and quarterly assessments determined by social network member self-report
- Willingness to participate in social network meetings determined by social network member self-report
Exclusion Criteria:
- Family members who the client does not want involved in the social network meetings determined by client self-report
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social Network Meetings Group
This arm will receive Social Network Meetings for a 6 month period. Meetings may occur as often as 3 times a week when there is a crisis or more commonly would occur once every other week. These meetings will last between 60 and 90 minutes and will take place for however long the clients and their social networks would like within the project period. Ideally, each client and his/her Social Network would participate in 4 meetings during the 6 month period. This group would continue to receive care as usual with the addition of these meetings. *Final sample in this arm was N=3. |
Social Network Meetings are a type of family therapy that includes clients and members of their social network.The social network may include family members, friends or anyone else that clients believe can help them move toward recovery.
The meetings will focus on improving communication within the social network.
|
No Intervention: No Social Network Meetings Group
This arm will not receive the Social Network Meetings intervention. Clients in this arm will participate in the study for 6 months and receive care as usual during this time. *Final sample in this arm was N=1. |
|
Other: Social Network Members
This arm is comprised of individuals who are social network members of clients who are receiving the Social Network Meetings intervention. *Final sample in this arm was N=3 (social network members of arm 1). |
Social Network Meetings are a type of family therapy that includes clients and members of their social network.The social network may include family members, friends or anyone else that clients believe can help them move toward recovery.
The meetings will focus on improving communication within the social network.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in score on the Questionnaire about the Process of Recovery (QPR) from baseline to 6 months
Time Frame: We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
|
The QPR is a 15-item self-report survey which assesses individuals' perceptions of self and factors that are important to recovery.
Items on the QPR are rated on a 5-point Likert scale and range from "disagree strongly" to "agree strongly."
|
We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
|
Change in score on the SCORE-15 Index of Family Functioning and Change (SCORE-15) from baseline to 6 months
Time Frame: We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
|
The SCORE-15 is a 15-item self-report survey which assesses perceptions about a family's level of intimacy and support for one another.
It asks both clients and social network members to give impressions about the level of disclosure between family members, perceptions of trust, and how the family deals conflict and crisis.
|
We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Satisfaction Questionnaire
Time Frame: 6 Months
|
We developed a brief 5-item survey that will ask clients and social network members about their satisfaction with the Social Network Meetings.
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6 Months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kane JM, Robinson DG, Schooler NR, Mueser KT, Penn DL, Rosenheck RA, Addington J, Brunette MF, Correll CU, Estroff SE, Marcy P, Robinson J, Meyer-Kalos PS, Gottlieb JD, Glynn SM, Lynde DW, Pipes R, Kurian BT, Miller AL, Azrin ST, Goldstein AB, Severe JB, Lin H, Sint KJ, John M, Heinssen RK. Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program. Am J Psychiatry. 2016 Apr 1;173(4):362-72. doi: 10.1176/appi.ajp.2015.15050632. Epub 2015 Oct 20.
- Hamilton E, Carr A. Systematic Review of Self-Report Family Assessment Measures. Fam Process. 2016 Mar;55(1):16-30. doi: 10.1111/famp.12200. Epub 2015 Nov 19.
- Neil, S. T., Kilbride, M., Pitt, L., Nothard, S., Welford, M., Sellwood, W., & Morrison, A. P. (2009). The Questionnaire about the Process of Recovery: A measurement tool developed in collaboration with service users. Psychosis: Psychological, Social and Integrative Approaches, 1(2), 145-155.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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