Back to resultsOnTrackNY With the Option of Social Network Meetings
Primary Purpose
First Episode Psychosis, Schizophrenia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Network Meetings
Sponsored by
About this trial
This is an interventional treatment trial for First Episode Psychosis focused on measuring Social Network Meetings, First Episode Psychosis, OnTrackNY
Eligibility Criteria
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
Sites / Locations
- MHA of Westchester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Other
Arm Label
Social Network Meetings Group
No Social Network Meetings Group
Social Network Members
Arm Description
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.
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.
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).
Outcomes
Primary Outcome Measures
Change in score on the Questionnaire about the Process of Recovery (QPR) from baseline to 6 months
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."
Change in score on the SCORE-15 Index of Family Functioning and Change (SCORE-15) from baseline to 6 months
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.
Secondary Outcome Measures
Brief Satisfaction Questionnaire
We developed a brief 5-item survey that will ask clients and social network members about their satisfaction with the Social Network Meetings.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03464162
Brief Title
OnTrackNY With the Option of Social Network Meetings
Official Title
OnTrackNY With the Option of Social Network Meetings
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment failed. No sufficient interest in the study. Potential participants are not interested
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisa Dixon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Early intervention programs for psychosis help improve short-term treatment and recovery outcomes for individuals experiencing psychosis. OnTrackNY is a coordinated specialty care (CSC) program, developed to treat young adults within two years of experiencing a non-affective episode of psychosis. This project aims to expand the role of family engagement and support within the OnTrackNY model. Borrowing from the Needs Adapted and Open Dialogue models, the study team created a family therapy service that includes the client and members of his/her social network to navigate crises and assist in treatment planning. This service, Social Network Meetings, will be offered to individuals enrolled in the OnTrackNY@MHA program as an additional, voluntary, service option. The study proposes that the introduction of Social Network meetings may improve treatment and recovery outcomes.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis, Schizophrenia
Keywords
Social Network Meetings, First Episode Psychosis, OnTrackNY
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will choose if they want to receive Social Network Meetings or be in a group that does not receive Social Network Meetings. Entrance of clients 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. There will be a maximum of 15 participants (clients) in each group.
For participants who choose Social Network Meetings, at least one member of their social network will participate in the study as well.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Network Meetings Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No Social Network Meetings Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Social Network Members
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Social Network Meetings
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in score on the Questionnaire about the Process of Recovery (QPR) from baseline to 6 months
Description
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."
Time Frame
We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
Title
Change in score on the SCORE-15 Index of Family Functioning and Change (SCORE-15) from baseline to 6 months
Description
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.
Time Frame
We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
Secondary Outcome Measure Information:
Title
Brief Satisfaction Questionnaire
Description
We developed a brief 5-item survey that will ask clients and social network members about their satisfaction with the Social Network Meetings.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MHA of Westchester
City
Yonkers
State/Province
New York
ZIP/Postal Code
10701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26481174
Citation
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.
Results Reference
background
PubMed Identifier
26582601
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
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OnTrackNY With the Option of Social Network Meetings
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