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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03464162
Other study ID # 7597
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 11, 2018
Est. completion date January 11, 2019

Study information

Verified date March 2019
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. To determine the extent to which clients and their social networks find the Social Network meetings acceptable and beneficial. 2. To compare outcomes (family functioning, recovery) of individuals participating in Social Network meetings to those not participating.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 11, 2019
Est. primary completion date January 11, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Social Network Meetings
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.

Locations

Country Name City State
United States MHA of Westchester Yonkers New York

Sponsors (1)

Lead Sponsor Collaborator
Lisa Dixon

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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." We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
Primary 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. We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points
Secondary 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. 6 Months
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