Intervention for Persons Leaving Residential Substance Abuse Treatment

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: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Critical Time Intervention-Residential (CTI-R); Behavioral: Enhanced Usual Discharge Services-Residential

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Enrollment	Proportion of participants enrolled in the study as measured by the research records	Baseline
Change in retention	Proportion of participants completed the study as measured by the research records	3, 6, 9, and 12 months
Short-term Relapse	Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index	3 months
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)	3 months
Housing	Proportion of participants housed at the time of discharge	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term Social Support	Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey	3 months
Short-term Self-Efficacy	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	Level of mental health severity as measured by the Brief Symptom Inventory	3 months
Change in Relapse	Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index	3, 6, and 9 months
Long-term Relapse	Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index	12 months
Change in Social Support	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	Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey	12 months
Change in Self-Efficacy	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	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	Level of mental health severity as measured by the Brief Symptom Inventory	3, 6, and 9 months
Long-term Mental Health	Level of mental health severity as measured by the Brief Symptom Inventory	12 months

Collaborators and Investigators

• Sponsor: New York University
• Investigators: Principal Investigator: Jennifer I Manuel, PhD, New York University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Transition; Residential substance use treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID 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