- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350571
Brief Interventions for Drop-out Re-engagement
September 16, 2014 updated by: Yale University
Adaptive Brief Interventions for Drop-out Re-engagement
We will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome.
Study Overview
Status
Completed
Conditions
Detailed Description
We propose a 5-year Stage I behavioral therapy development study to: 1) prospectively evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a manual of single session phone-and office-based interventions to re-engage these individual in treatment.
Study Type
Interventional
Enrollment (Actual)
299
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- APT Foundation
-
New Haven, Connecticut, United States, 06510
- Connecticut Mental Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- admission to outpatient treatment
Exclusion Criteria:
- need for hospitalization
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard care follow up
Standard care counselor follow up care phone calls or letters.
|
routine counselor phone calls and letters
|
|
Experimental: Drop out reengagement motivational intervention
Single session office based or phone based motivational counseling session designed to promote participant re-engagement in standard treatment.
|
up t 3 sessions of phone or office based counseling sessions to promote re-engagement in treatment.
Up to 3 phone or office based counseling sessions to promote reengagement in treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
retention into outpatient treatment
Time Frame: 4, 8, 12, 24 weeks
|
4, 8, 12, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
substance abuse
Time Frame: 4, 8,12,and 24 weeks
|
4, 8,12,and 24 weeks
|
|
psychiatric symptoms
Time Frame: 4, 8, 12, and 24 weeks
|
4, 8, 12, and 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sam Ball, PhD, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
July 7, 2006
First Submitted That Met QC Criteria
July 10, 2006
First Posted (Estimate)
July 11, 2006
Study Record Updates
Last Update Posted (Estimate)
September 17, 2014
Last Update Submitted That Met QC Criteria
September 16, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101010101
- 5P50DA009241-120012
- 5P50DA009241 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.