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Trial record 3 of 34 for:    substance abuse | Not yet recruiting Studies

Intervention for Persons Leaving Residential Substance Abuse Treatment

This study is not yet open for participant recruitment.
Verified September 2016 by Jennifer Manuel, New York University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02670902
First Posted: February 2, 2016
Last Update Posted: September 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Manuel, New York University
  Purpose
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 co-occurring substance use and mental health problems 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 with co-occurring problems in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals with co-occurring disorders 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.

Condition Intervention
Substance Use Disorders Mental Disorders Health Behavior Behavioral: Critical Time Intervention-Residential (CTI-R) Behavioral: Enhanced Usual Discharge Services-Residential

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention for Persons With Co-Occurring Disorders Leaving Residential Tx

Further study details as provided by Jennifer Manuel, New York University:

Primary Outcome Measures:
  • Proportion of participants completed the study as measured by participants' and staff's research records [ Time Frame: 12 months ]
  • Level of satisfaction with CTI-R intervention as measured by participants' and staff's research records [ Time Frame: 12 months ]
  • Proportion of participants who relapsed (i.e., readmission to residential treatment, hospitalization or emergency room use) as measured by Treatment Service Review (TSR) [ Time Frame: 6, 9, 12 months ]

Secondary Outcome Measures:
  • Proportion of participants who used aftercare services (i.e. mental health services, physical health services, substance use treatments) as measured by Treatment Service Review (TSR) [ Time Frame: 12 months ]
  • Level of emotional and tangible support as measured by Norbeck Social Support Questionnaire (NSSQ) [ Time Frame: 12 months ]
  • Level of substance use severity as measured by Addiction Severity Index - Lite Version (ASI-Lite) [ Time Frame: 12 months ]
  • Level of mental health severity as measured by Brief Symptoms Inventory-18 (BSI-18) [ Time Frame: 12 months ]
  • Number of barriers to service use as measured by Allen Barriers to Treatment Scale (ABTS) [ Time Frame: 12 months ]

Estimated Enrollment: 60
Study Start Date: December 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, as well as three telephone recovery check-up calls post-discharge.
Active Comparator: Enhanced Usual Discharge-Residential
The enhanced usual discharge condition includes usual discharge services plus three telephone recovery check-up calls post-discharge.
Behavioral: Enhanced Usual Discharge Services-Residential
The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program, as well as three telephone recovery check-up calls post-discharge.

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 in the CTI group will receive pre-discharge preparation and planning services, as usual, in addition to 9 months of assertive outreach and support following discharge. Participants in the enhanced usual discharge services group will receive pre-discharge preparation and planning services and three telephone recovery check-up calls following discharge. Participants will complete a baseline interview (prior to randomization) and 3-, 6-, and 12-month follow-up assessments post-discharge. All participants will be invited to participate in gender and program-specific focus groups to explore barriers and facilitators to transition and the support received. This means that separate focus groups will be conducted for the CTI and enhanced usual discharge groups and for women and men. The investigators expect to conduct four focus groups: one for women in CTI, one for women in usual discharge services, one for men in CTI, and one for men in enhanced usual discharge services.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670902


Contacts
Contact: Jennifer I Manuel, PhD 212-998-5972 jennifer.manuel@nyu.edu

Locations
United States, New York
New York University Not yet recruiting
New York, New York, United States, 10003
Contact: Jennifer I Manuel, PhD    212-998-5972    jennifer.manuel@nyu.edu   
Principal Investigator: Jennifer I Manuel, PhD         
Sponsors and Collaborators
New York University
Investigators
Principal Investigator: Jennifer I Manuel, PhD New York University
  More Information

Responsible Party: Jennifer Manuel, Assistant Professor, New York University
ClinicalTrials.gov Identifier: NCT02670902     History of Changes
Other Study ID Numbers: K01DA035330 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2016
First Posted: February 2, 2016
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Substance-Related Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Chemically-Induced Disorders