NCT03464162

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2019

Completed
Last Updated

August 14, 2023

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

March 5, 2018

Last Update Submit

August 10, 2023

Conditions

Keywords

Social Network MeetingsFirst Episode PsychosisOnTrackNY

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Brief Satisfaction Questionnaire

    6 Months

Study Arms (3)

Social Network Meetings Group

EXPERIMENTAL

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.

Behavioral: Social Network Meetings

No Social Network Meetings Group

NO INTERVENTION

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.

Social Network Members

OTHER

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).

Behavioral: Social Network Meetings

Interventions

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.

Social Network Meetings GroupSocial Network Members

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Ages 16-30
  • Currently enrolled clients in the OnTrackNY program at MHA Westchester determined by MHA Westchester Client Roster for OnTrackNY
  • Anyone who the OnTrackNY team determines is clinically unstable determined by clinician assessment
  • Subject Population 3: Social Network Member (ages 18+)
  • 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
  • Family members who the client does not want involved in the social network meetings determined by client self-report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MHA of Westchester

Yonkers, New York, 10701, United States

Location

Related Publications (3)

  • 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.

    PMID: 26481174BACKGROUND
  • 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.

    PMID: 26582601BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 13, 2018

Study Start

April 11, 2018

Primary Completion

January 11, 2019

Study Completion

January 11, 2019

Last Updated

August 14, 2023

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations