NCT02670902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

January 25, 2016

Last Update Submit

October 31, 2022

Conditions

Substance Use Disorders

Keywords

Residential substance use treatmentTransition

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (11)

  • Short-term Social Support

    3 months

  • Short-term Self-Efficacy

    3 months

  • Short-term Mental Health

    3 months

  • Change in Relapse

    3, 6, and 9 months

  • Long-term Relapse

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Critical Time Intervention-Residential

EXPERIMENTAL

CTI-R is a 9-month, assertive outreach and linkage program.

Behavioral: Critical Time Intervention-Residential (CTI-R)Behavioral: Enhanced Usual Discharge Services-Residential

Enhanced Usual Discharge-Residential

ACTIVE COMPARATOR

The enhanced usual discharge condition includes usual discharge services plus enhanced transition services.

Behavioral: Enhanced Usual Discharge Services-Residential

Interventions

Critical Time Intervention-Residential (CTI-R)BEHAVIORAL

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.

Critical Time Intervention-Residential
Enhanced Usual Discharge Services-ResidentialBEHAVIORAL

The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition services.

Critical Time Intervention-ResidentialEnhanced Usual Discharge-Residential

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Jennifer I Manuel, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 2, 2016

Study Start

May 1, 2017

Primary Completion

May 1, 2020

Study Completion

December 31, 2020

Last Updated

November 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)