- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01970293
AA Linkage for Alcohol Abusing Women Leaving Jail
September 8, 2020 updated by: Butler Hospital
The primary aims of this study are to test the hypotheses that among alcohol abusing and dependent jailed women returning to the community, adding an Alcoholic Anonymous (AA) linkage intervention will result in less alcohol use at follow-up, increased AA attendance once released, and decreased HIV/STI sexual risk behavior.
Additionally, this study seeks to test the hypotheses that increased AA attendance will mediate the effect of the AA linkage intervention on alcohol use and that percent days abstinent will mediate the effect of the intervention on HIV/STI sexual risk-taking outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Not Applicable
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
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
To be eligible for the study participants must:
- Be 18 years or older
- Live in RI or MA within 20 miles of Providence and plan to remain in the area for the next 6 months
- Meet DSM-IV criteria for alcohol abuse or dependence in the last six months
- Do not expect to attend residential alcohol or drug treatment upon release
- Report STI/HIV sexual risk defined as unprotected heterosexual sex at least three times in the three months prior to incarceration
- Speak English.
- Be currently held at the Rhode Island Adult Correctional Institutions Jail facility
Women will be excluded from participation if they:
1. Cannot provide the name of at least two locator persons who will know where they can be found.
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Introduction to AA volunteer
|
In-person, in jail introduction to an AA volunteer, who will offer assistance in attending 2 AA meetings.
|
|
No Intervention: AA materials offered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of alcohol use days from baseline to 6 months
Time Frame: Baseline, 1, 3, and 6 months
|
Timeline Followback (TLFB) participant recall of alcohol use days.
|
Baseline, 1, 3, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Timko C, Chatav Schonbrun Y, Anderson B, Johnson JE, Stein M. Perceived Substance Use Norms Among Jailed Women with Alcohol Use Disorders. Alcohol Clin Exp Res. 2020 Sep;44(9):1834-1841. doi: 10.1111/acer.14403. Epub 2020 Sep 2.
- Schonbrun YC, Kurth M, Johnson J, Timko C, Stein M. Participant Evaluation of Twelve-Step Group Linkage for Jailed Women With Alcohol Use Disorder. Int J Offender Ther Comp Criminol. 2019 Mar;63(4):610-623. doi: 10.1177/0306624X18805598. Epub 2018 Oct 12.
- Timko C, Johnson JE, Kurth M, Schonbrun YC, Anderson BJ, Stein MD. Health Services Use Among Jailed Women with Alcohol Use Disorders. J Behav Health Serv Res. 2019 Jan;46(1):116-128. doi: 10.1007/s11414-018-9634-7.
- Hailemariam M, Stein M, Anderson B, Schonbrun YC, Moore K, Kurth M, Richie F, Johnson JE. Correlates of alcoholics anonymous affiliation among justice-involved women. BMC Womens Health. 2018 Jul 11;18(1):125. doi: 10.1186/s12905-018-0614-0.
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 (Actual)
October 1, 2013
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
August 8, 2013
First Submitted That Met QC Criteria
October 22, 2013
First Posted (Estimate)
October 28, 2013
Study Record Updates
Last Update Posted (Actual)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 8, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01AA021732-01A1 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Alcohol Use
-
Women's College HospitalRecruitingAlcohol; Harmful Use | Tobacco Use | Tobacco Use Cessation | Alcohol Use, UnspecifiedCanada
-
University of Central FloridaEnrolling by invitationAlcohol Use, Underage | Harmful; Use, AlcoholUnited States
-
University of Colorado, DenverUnknownAlcohol Use Disorders | Unhealthy Alcohol UseUnited States
-
Indiana UniversityPatient-Centered Outcomes Research InstituteRecruitingAdolescent | Alcohol Use | Mild Alcohol Use Disorder | Mild Substance Use DisorderUnited States
-
Spark Biomedical, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA); Baylor College... and other collaboratorsRecruitingSubstance Use Disorders | Alcohol Use Disorder | Alcohol Abuse | Substance Use Disorders Alcohol Use Withdrawal StateUnited States
-
Université du Québec à Trois-RivièresCompletedAlcohol Use, Unspecified | Alcohol Use Disorder, MildCanada
-
University of North Carolina, Chapel HillCompletedAlcohol Use Disorder, Mild | Alcohol Use Disorder, ModerateUnited States
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
H. Lee Moffitt Cancer Center and Research InstituteNational Institutes of Health (NIH); National Center for Complementary and...CompletedTobacco Use | Alcohol Use, UnspecifiedUnited States
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)CompletedAlcohol Drinking | Alcohol Use Norms | Alcohol Use Among ART ClientsVietnam
Clinical Trials on Introduction to AA volunteer
-
University of UtahCompletedPhysical ExertionUnited States
-
Hamilton Health Sciences CorporationUniversity of OttawaCompleted
-
VA Office of Research and DevelopmentDurham VA Medical Center; US Department of Veterans Affairs Center for Healthcare...CompletedIntroduction of Teledermatology Mobile AppsUnited States
-
Wang XiaweiCompletedIntervention | Psychological Well-BeingChina
-
University of Alabama at BirminghamMontefiore Medical Center; National Institute on Aging (NIA); University of Massachusetts... and other collaboratorsRecruitingHealthy Aging | Health Knowledge, Attitudes, Practice | Social Responsibility | Care Eliciting Behavior | Racism, SystemicUnited States
-
Cambridge Health AllianceBrown University; National Institutes of Health (NIH); National Center for Complementary... and other collaboratorsCompletedDepression | Anxiety | Adjustment Disorders | Stress Related DisorderUnited States
-
Unity Health TorontoCompleted
-
DexCom, Inc.Jaeb Center for Health ResearchCompletedDiabetes MellitusUnited States
-
Shaheed Mohtarma Benazir Bhutto Institue of TraumaCompletedInfant | Complementary FeedingPakistan
-
Ajinomoto Co., Inc.Great Ormond Street Hospital for Children NHS Foundation Trust; Birmingham...Active, not recruiting