OnTrackNY With the Option of Social Network Meetings

OnTrackNY With the Option of Social Network Meetings



Sponsors

Lead Sponsor



Source

New York State Psychiatric Institute

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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 [email protected] 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 [email protected] 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.

Overall Status

Not yet recruiting

Start Date

2018-04-11

Completion Date

2019-03-20

Primary Completion Date

2019-01-20

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change in score on the Questionnaire about the Process of Recovery (QPR) from baseline to 6 months
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
We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points

Secondary Outcome

Measure

Time Frame

Brief Satisfaction Questionnaire
6 Months

Enrollment

30

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


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.

Arm Group Label

Social Network Meetings Group


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

Gender

All

Minimum Age

16 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Lisa Dixon, MD

Phone

646-774-8420

Email



Verification Date

2018-04-01

Lastchanged Date

2018-04-06

Firstreceived Date

2018-03-05

Responsible Party

Responsible Party Type

Sponsor-Investigator

Investigator Affiliation

New York State Psychiatric Institute

Investigator Full Name

Lisa Dixon

Investigator Title

Dr.


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Social Network Meetings Group

Arm Group Type

Experimental

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.


Arm Group Label

No Social Network Meetings Group

Arm Group Type

No Intervention

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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Sacha Zilkha, PhD

Phone

646-774-8469

Email



Reference

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.

PMID

26481174


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. Review.

PMID

26582601


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.



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Intervention 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.

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

March 5, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

April 6, 2018

Last Update Submitted Qc

April 6, 2018

Last Update Posted

April 10, 2018


ClinicalTrials.gov processed this data on April 10, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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