First Episode PsychosisNCT03464162

OnTrackNY With the Option of Social Network Meetings

A study testing Social Network Meetings in people with First Episode Psychosis and Schizophrenia, run by Lisa Dixon at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: First Episode Psychosis, Schizophrenia
What is being tested?: Social Network Meetings
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 11 Apr 2018to 11 Jan 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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
Ages 16-30
Currently enrolled clients in the OnTrackNY program at MHA Westchester determined by MHA Westchester Client Roster for OnTrackNY

Show all 10Show fewer

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

Who cannot join

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)
Anyone who the OnTrackNY team determines is clinically unstable determined by clinician assessment
Subject Population 3: Social Network Member (ages 18+)
Family members who the client does not want involved in the social network meetings determined by client self-report

Trial locations and contacts

1 site in 1 country.

United States1 site

MHA of Westchester
Yonkers, New York, 10701

Other trials in United States

About this study

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.

Read the 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.

Conditions: First Episode Psychosis, Schizophrenia
Being tested: Social Network Meetings
Keywords: Social Network Meetings, First Episode Psychosis, OnTrackNY
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Social Network MeetingsBehavioural
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.

Study groups in NCT03464162
Study group	Role	What they receive
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. Receives: 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). Receives: Behavioral: Social Network Meetings

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 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.
Measured: We will measure scores at baseline, 3 months and 6 months to determine change between these assessment points

Secondary outcomes (1)

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.
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 201811 Jan 2019

First posted13 Mar 2018
Study start11 Apr 2018
Primary completion11 Jan 2019
Study completion11 Jan 2019

Why it stopped: Recruitment failed. No sufficient interest in the study. Potential participants are not interested

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for First Episode PsychosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03464162
Sponsor's protocol ID: 7597
Status last verified: Mar 2019
First submitted: 5 Mar 2018
Last updated: 14 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 26481174
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.
PubMed 26582601
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All First Episode Psychosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: OnTrackNY With the Option of Social Network Meetings
ClinicalTrials.gov ID: NCT03464162
Acronym / sponsor ID: 7597
Conditions: First Episode Psychosis, Schizophrenia
Keywords: Social Network Meetings, First Episode Psychosis, OnTrackNY
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Recruitment failed. No sufficient interest in the study. Potential participants are not interested
Enrolment: 0 participants (actual)
Lead sponsor: Lisa DixonUniversity, hospital or other
Study start: 11 Apr 2018 (actual)
Primary completion: 11 Jan 2019 (actual)
Study completion: 11 Jan 2019 (actual)
First posted: 13 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
Social Network Meetings Group	Experimental	Behavioral: Social Network MeetingsThis 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.
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	Behavioral: Social Network MeetingsThis 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).

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

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
Ages 16-30

Key exclusion criteria (6 listed)

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)
Anyone who the OnTrackNY team determines is clinically unstable determined by clinician assessment
Subject Population 3: Social Network Member (ages 18+)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Social Network MeetingsSocial 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.	Behavioural	Social Network Meetings Group, Social Network Members

Primary outcome

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."
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.

1 secondary outcome

Brief Satisfaction Questionnaire
Time frame: 6 Months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Background: PubMed 26481174Kane 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.
Background: PubMed 26582601Hamilton 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.
BackgroundNeil, 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.
Individual participant dataSharing planned: No

Related trials for First Episode Psychosis

Recruiting
On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
Sleep, Physical Activity
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
RecruitingPhase 3
Stratification and Treatment in Early Psychosis Study - ENHANCE
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Active, not recruitingEarly Phase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Social Network Meetings in people with First Episode Psychosis and Schizophrenia, run by Lisa Dixon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03464162, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.