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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02670902
Other study ID # K01DA035330
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date December 31, 2020

Study information

Verified date May 2022
Source New York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States New York University New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Enrollment Proportion of participants enrolled in the study as measured by the research records Baseline
Primary Change in retention Proportion of participants completed the study as measured by the research records 3, 6, 9, and 12 months
Primary Short-term Relapse Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index 3 months
Primary 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
Primary Housing Proportion of participants housed at the time of discharge 3 months
Secondary Short-term Social Support Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey 3 months
Secondary 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
Secondary Short-term Mental Health Level of mental health severity as measured by the Brief Symptom Inventory 3 months
Secondary Change in Relapse Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index 3, 6, and 9 months
Secondary Long-term Relapse Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index 12 months
Secondary 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
Secondary Long-term Social Support Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey 12 months
Secondary 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
Secondary 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
Secondary Change in Mental Health Level of mental health severity as measured by the Brief Symptom Inventory 3, 6, and 9 months
Secondary Long-term Mental Health Level of mental health severity as measured by the Brief Symptom Inventory 12 months
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