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

November 1, 2022 updated by: Katherine Elkington, New York State Psychiatric Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Youth:

Inclusion Criteria

  1. Between 10-18 years of age
  2. English speaking
  3. A caregiver who will participate in the study
  4. 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
  5. Currently on probation

Exclusion Criteria 1. Cognitively unable to complete the interview

Caregiver:

Inclusion criteria

  1. Youth's legal guardian (or permission from legal guardian)
  2. Youth who will participate
  3. English speaking

Exclusion criteria:

1. Cognitively unable to complete the interview

Probation staff:

Inclusion criteria:

1. Currently employed at probation department

Exclusion criterion:

1. None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care
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.
Experimental: Family CONNECT
This arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.
Behavioral: Family CONNECT
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Two years (study implementation period)
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
Two years (study implementation period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Youth Referred for Substance Use Treatment
Time Frame: Two years (study implementation period)
Number of youth referred to substance use treatment
Two years (study implementation period)
Youth Referred for Any Behavioral Health Treatment
Time Frame: two years (implementation period)
Number of youth who are referred to any behavioral health treatment
two years (implementation period)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Youth Initiated Substance Use Treatment
Time Frame: Two years (study implementation period)
Number of youth who attended an additional substance use treatment appointment following intake.
Two years (study implementation period)
Youth Initiated Any Behavioral Health Treatment
Time Frame: two years (study implementation period)
Number of youth who attended an additional behavioral health treatment appointment following intake.
two years (study implementation period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York State Psychiatric Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine S Elkington, PhD, New York State Psychiatric Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7108
  • R34DA039316 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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