Substance UseNCT03048552

Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3

A study testing Family CONNECT in people with Substance Use and Substance Abuse, run by New York State Psychiatric Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Substance Use, Substance Abuse, Substance Use Disorders
What is being tested?: Family CONNECT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: No sites listed yet
Study dates: 17 Nov 2016to 1 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Between 10-18 years of age
English speaking
A caregiver who will participate in the study
MAYSI-2 score of ≥ 4 on any MAYSI-2 subscale; YASI mental health and substance use screen items; or other documented evidence of mental health or substance use problem
Currently on probation
Exclusion Criteria 1. Cognitively unable to complete the interview

Show all 11Show fewer

Caregiver:
Youth's legal guardian (or permission from legal guardian)
Youth who will participate
English speaking
1. Currently employed at probation department

Who cannot join

1. Cognitively unable to complete the interview
Probation staff:
1. None

About this study

Developed from adapting and combining two evidence-based programs, Project CONNECT (a linkage-to-services program that targets barriers within the probation and substance abuse treatment systems) and TIES (a program that teaches family engagement skills to providers), Family CONNECT is a linkage-to-services program that targets both family and system-level factors to increase youth use of and retention in substance use services. Using Linkage Specialists embedded within probation departments, Family CONNECT will be implemented in two NYS probation departments. This proposed study will evaluate the impact of Family CONNECT on (1) youth referral from probation to substance abuse treatment, (2) youth and family engagement in substance abuse treatment, (3) youth enrollment/retention in substance abuse treatment, and (4) youth substance use and recidivism. Counts of youth referred, youth who start treatment, and youth retained in treatment will be obtained from the juvenile justice agency for 6-months pre-implementation of Family Connect (i.e. baseline) and during the implementation period of e-Connect; counts of youth recidivism will be obtained 6 months following the completion of Family Connect. This study will also identify family and probation organizational factors influencing Family CONNECT implementation in probation settings. 50 caregiver-youth dyads and up to 36 probation officers will be recruited as participants in the study. Caregiver-youth dyads will be evaluated at baseline, 2 and 6 months; probation officers at baseline, 6, 12, and 18 months; linkage specialists at baseline, 6, 12, and 18 months.

Conditions: Substance Use, Substance Abuse, Substance Use Disorders, Substance-Related Disorders, Substance Dependence, Substance Related Problem
Being tested: Family CONNECT
Keywords: drug use, drug addiction, drug habituation, drug use disorders, organic mental disorders, substance-induced, substance abuse, substance addiction, substance dependence, substance use disorders
Medical subject headings: Substance-Related Disorders, Neurocognitive Disorders

What participants receive

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

Family CONNECTBehavioural
Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services.

Study groups in NCT03048552
Study group	Role	What they receive
Standard of Care	No intervention	This arm is comprised of caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
Family CONNECT	Experimental	This arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services. Receives: Behavioral: Family CONNECT

What is being measured

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

Youth Enrolled in Substance Use Treatment
Count of youth participants enrolled in substance use treatment based on self-report or administrative records
Measured: Two years (study implementation period)
Youth Enrolled in Any Behavioral Health Treatment
Number of youth enrolled in any behavioral health treatment (incl. mental health and substance use) within the past 6 months
Measured: Two years (study implementation period)

Secondary outcomes (2)

Youth Referred for Substance Use Treatment
Number of youth referred to substance use treatment
Measured: Two years (study implementation period)
Youth Referred for Any Behavioral Health Treatment
Number of youth who are referred to any behavioral health treatment
Measured: two years (implementation period)

Timeline

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

17 Nov 20161 Dec 2018

First posted9 Feb 2017 (estimated)
Study start17 Nov 2016
Primary completionDec 2018
Study completion1 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Substance UseStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study is a randomized control trial. Caregiver-youth dyads are randomized to either the control (standard of care) or experimental (Family CONNECT) group based on the youth's probation officer (randomization occurs at the level of the youth's probation officer). If randomized to the control (standard of care) group, caregiver-youth dyads will work with their probation officer as usual to link to substance use services. If randomized to the experimental (Family CONNECT) group, caregiver-youth dyads will work with a linkage specialist to link to substance use services. Youth in both groups will be compared to a baseline stand of care collected during the pre-implementation period.
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03048552
Sponsor's protocol ID: 7108
Other IDs: R34DA039316
Status last verified: Nov 2022
First submitted: 7 Feb 2017
Last updated: 3 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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?

Official record

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All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3
ClinicalTrials.gov ID: NCT03048552
Acronym / sponsor ID: 7108
Conditions: Substance Use, Substance Abuse, Substance Use Disorders, Substance-Related Disorders, Substance Dependence, Substance Related Problem
Keywords: drug use, drug addiction, drug habituation, drug use disorders, organic mental disorders, substance-induced, substance abuse, substance addiction
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 17 Nov 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: 1 Dec 2018 (actual)
First posted: 9 Feb 2017 (estimated)
Results: Posted 11 May 2022

Clinical summary

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This study is a randomized control trial. Caregiver-youth dyads are randomized to either the control (standard of care) or experimental (Family CONNECT) group based on the youth's probation officer (randomization occurs at the level of the youth's probation officer). If randomized to the control (standard of care) group, caregiver-youth dyads will work with their probation officer as usual to link to substance use services. If randomized to the experimental (Family CONNECT) group, caregiver-youth dyads will work with a linkage specialist to link to substance use services. Youth in both groups will be compared to a baseline stand of care collected during the pre-implementation period.

Arm	Type	Receives
Standard of Care	No intervention	–This arm is comprised of caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
Family CONNECT	Experimental	Behavioral: Family CONNECTThis arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

Between 10-18 years of age
English speaking
A caregiver who will participate in the study
MAYSI-2 score of ≥ 4 on any MAYSI-2 subscale; YASI mental health and substance use screen items; or other documented evidence of mental health or substance use problem
Currently on probation

Key exclusion criteria (3 listed)

1. Cognitively unable to complete the interview
1. None

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
Family CONNECTLinkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services.	Behavioural	Family CONNECT

Primary outcome

Youth Enrolled in Substance Use Treatment
Time frame: Two years (study implementation period)
Count of youth participants enrolled in substance use treatment based on self-report or administrative records
Youth Enrolled in Any Behavioral Health Treatment
Time frame: Two years (study implementation period)
Number of youth enrolled in any behavioral health treatment (incl. mental health and substance use) within the past 6 months

2 secondary outcomes

Youth Referred for Substance Use Treatment
Time frame: Two years (study implementation period)
Youth Referred for Any Behavioral Health Treatment
Time frame: two years (implementation period)

Results and safety

Results posted to the registry on 11 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care - Youth	4	4
Family CONNECT - Youth	18	18
Standard of Care - Caregiver	4	4
Family CONNECT - Caregiver	15	15

Primary outcome: Youth Enrolled in Substance Use Treatment

Time frame: Two years (study implementation period). Count of participants. Unit: Participants

Measure	Standard of Care- YOUTH n = 4	Family CONNECT- YOUTH n = 18
Enrolled	0	12
Did not enroll	4	6

Population analysed: Youth on probation with identified substance use need

Primary outcome: Youth Enrolled in Any Behavioral Health Treatment

Time frame: Two years (study implementation period). Count of participants. Unit: Participants

Measure	Standard of Care- YOUTH n = 4	Family CONNECT- YOUTH n = 18
Attended intake appointment	2	15
No intake	2	3

Standard of Care- YOUTH vs Family CONNECT- YOUTH: p = 0.148, Fisher Exact

Population analysed: Youth on probation with identified substance use need

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months for standard of car arm; between 6 and 13 months for treatment arm. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care- Youth	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Family CONNECT- Youth	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Standard of Care- Caregivers	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Family CONNECT- Caregivers	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Katherine S Elkington, PhD principal investigator

New York State Psychiatric Institute

Questions about this trial

What is this clinical trial studying?

A study testing Family CONNECT in people with Substance Use and Substance Abuse, run by New York State Psychiatric Institute.

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 11 inclusion and 3 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: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 11 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Youth Enrolled in Substance Use Treatment (time frame: Two years (study implementation period)). 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 NCT03048552.

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 3 Nov 2022.