Back to resultsIntervention for Persons Leaving Residential Substance Abuse Treatment
Primary Purpose
Substance Use Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Critical Time Intervention-Residential (CTI-R)
Enhanced Usual Discharge Services-Residential
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring Residential substance use treatment, Transition
Eligibility 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:
- Anyone under the age of 18
- Non-English speaking individuals due to limited resources
- Individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners.
- Individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.
Sites / Locations
- New York University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Critical Time Intervention-Residential
Enhanced Usual Discharge-Residential
Arm Description
CTI-R is a 9-month, assertive outreach and linkage program.
The enhanced usual discharge condition includes usual discharge services plus enhanced transition services.
Outcomes
Primary Outcome Measures
Enrollment
Proportion of participants enrolled in the study as measured by the research records
Change in retention
Proportion of participants completed the study as measured by the research records
Short-term Relapse
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Use of aftercare services
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)
Housing
Proportion of participants housed at the time of discharge
Secondary Outcome Measures
Short-term Social Support
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Short-term Self-Efficacy
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Short-term Mental Health
Level of mental health severity as measured by the Brief Symptom Inventory
Change in Relapse
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Long-term Relapse
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Change in Social Support
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Long-term Social Support
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Change in Self-Efficacy
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Long-term Self-Efficacy
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Change in Mental Health
Level of mental health severity as measured by the Brief Symptom Inventory
Long-term Mental Health
Level of mental health severity as measured by the Brief Symptom Inventory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02670902
Brief Title
Intervention for Persons Leaving Residential Substance Abuse Treatment
Official Title
Intervention for Persons With Co-Occurring Disorders Leaving Residential Tx
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Residential substance use treatment, Transition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Critical Time Intervention-Residential
Arm Type
Experimental
Arm Description
CTI-R is a 9-month, assertive outreach and linkage program.
Arm Title
Enhanced Usual Discharge-Residential
Arm Type
Active Comparator
Arm Description
The enhanced usual discharge condition includes usual discharge services plus enhanced transition services.
Intervention Type
Behavioral
Intervention Name(s)
Critical Time Intervention-Residential (CTI-R)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Discharge Services-Residential
Intervention Description
The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition services.
Primary Outcome Measure Information:
Title
Enrollment
Description
Proportion of participants enrolled in the study as measured by the research records
Time Frame
Baseline
Title
Change in retention
Description
Proportion of participants completed the study as measured by the research records
Time Frame
3, 6, 9, and 12 months
Title
Short-term Relapse
Description
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Time Frame
3 months
Title
Use of aftercare services
Description
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)
Time Frame
3 months
Title
Housing
Description
Proportion of participants housed at the time of discharge
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Short-term Social Support
Description
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Time Frame
3 months
Title
Short-term Self-Efficacy
Description
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Time Frame
3 months
Title
Short-term Mental Health
Description
Level of mental health severity as measured by the Brief Symptom Inventory
Time Frame
3 months
Title
Change in Relapse
Description
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Time Frame
3, 6, and 9 months
Title
Long-term Relapse
Description
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Time Frame
12 months
Title
Change in Social Support
Description
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Time Frame
3, 6, and 9 months
Title
Long-term Social Support
Description
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Time Frame
12 months
Title
Change in Self-Efficacy
Description
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Time Frame
3, 6, and 9 months
Title
Long-term Self-Efficacy
Description
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Time Frame
12 months
Title
Change in Mental Health
Description
Level of mental health severity as measured by the Brief Symptom Inventory
Time Frame
3, 6, and 9 months
Title
Long-term Mental Health
Description
Level of mental health severity as measured by the Brief Symptom Inventory
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Anyone under the age of 18
Non-English speaking individuals due to limited resources
Individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners.
Individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer I Manuel, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Intervention for Persons Leaving Residential Substance Abuse Treatment
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