Intervention for Persons Leaving Residential Substance Abuse Treatment

October 31, 2022 updated by: New York University

Intervention for Persons With Co-Occurring Disorders Leaving Residential Tx

This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.

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.

Detailed Description

This randomized pilot study will examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services. More specifically, 60 participants will be randomized to either CTI (n=30) or enhanced usual discharge planning services (n=30) at the time of discharge. Participants will complete a baseline interview (prior to randomization) and 3-, 6-, 9- and 12-month follow-up assessments post-discharge.

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.
60

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible participants will be enrolled in residential substance abuse treatment and who are at least 18 years of age, speak English, and expect to be discharged within 3 months.

Exclusion Criteria:

  • Individuals that do not meet the aforementioned inclusion criteria will be excluded from the study.More specifically, the following categories will be excluded:

    1. Anyone under the age of 18
    2. Non-English speaking individuals due to limited resources
    3. Individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners.
    4. Individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.

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: Treatment
  • 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.
Experimental: Critical Time Intervention-Residential
CTI-R is a 9-month, assertive outreach and linkage program.
Behavioral: Critical Time Intervention-Residential (CTI-R)
CTI-R is a 9-month, time-limited intervention that aims to produce an enduring impact by effectively linking individuals to both professional services (substance abuse and health and mental health providers) and social supports (e.g., family and friends) and by providing emotional and practical support. Participants in the CTI-R condition will also receive usual discharge services from the residential substance abuse treatment program.
Behavioral: Enhanced Usual Discharge Services-Residential
The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition services.
Active Comparator: Enhanced Usual Discharge-Residential
The enhanced usual discharge condition includes usual discharge services plus enhanced transition services.
Behavioral: Enhanced Usual Discharge Services-Residential
The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition 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
Enrollment
Time Frame: Baseline
Proportion of participants enrolled in the study as measured by the research records
Baseline
Change in retention
Time Frame: 3, 6, 9, and 12 months
Proportion of participants completed the study as measured by the research records
3, 6, 9, and 12 months
Short-term Relapse
Time Frame: 3 months
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
3 months
Use of aftercare services
Time Frame: 3 months
Proportion of participants who were linked to aftercare services (i.e. substance use treatment) at the time of discharge as measured by the Treatment Service Review (TSR)
3 months
Housing
Time Frame: 3 months
Proportion of participants housed at the time of discharge
3 months

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
Short-term Social Support
Time Frame: 3 months
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
3 months
Short-term Self-Efficacy
Time Frame: 3 months
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
3 months
Short-term Mental Health
Time Frame: 3 months
Level of mental health severity as measured by the Brief Symptom Inventory
3 months
Change in Relapse
Time Frame: 3, 6, and 9 months
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
3, 6, and 9 months
Long-term Relapse
Time Frame: 12 months
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
12 months
Change in Social Support
Time Frame: 3, 6, and 9 months
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
3, 6, and 9 months
Long-term Social Support
Time Frame: 12 months
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
12 months
Change in Self-Efficacy
Time Frame: 3, 6, and 9 months
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
3, 6, and 9 months
Long-term Self-Efficacy
Time Frame: 12 months
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
12 months
Change in Mental Health
Time Frame: 3, 6, and 9 months
Level of mental health severity as measured by the Brief Symptom Inventory
3, 6, and 9 months
Long-term Mental Health
Time Frame: 12 months
Level of mental health severity as measured by the Brief Symptom Inventory
12 months

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 University

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: Jennifer I Manuel, PhD, New York University

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.
May 1, 2017

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.
May 1, 2020

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 31, 2020

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).
January 25, 2016

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 1, 2016

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 2, 2016

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 1, 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.
October 31, 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.
May 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.
  • K01DA035330 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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