Alcohol UseNCT01970293
AA Linkage for Alcohol Abusing Women Leaving Jail
A study testing Introduction to AA volunteer in people with Alcohol Use and AA Attendance, run by Butler Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, AA Attendance, Sexual Risk Behavior
- What is being tested?
- Introduction to AA volunteer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Use, AA Attendance, Sexual Risk Behavior
- Being tested
- Introduction to AA volunteer
- Keywords
- Alcohol use, STI, Incarcerated women, AA
- Medical subject headings
- Alcohol Drinking, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction to AA volunteerOther
In-person, in jail introduction to an AA volunteer, who will offer assistance in attending 2 AA meetings.
| Study group | Role | What they receive |
|---|---|---|
| Introduction to AA volunteer | Other | Not described Receives: Other: Introduction to AA volunteer |
| AA materials offered | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of alcohol use days from baseline to 6 months
Timeline Followback (TLFB) participant recall of alcohol use days.
Measured: Baseline, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970293
- Sponsor's protocol ID
- 1R01AA021732-01A1
- Status last verified
- Sep 2020
- First submitted
- 8 Aug 2013
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32876998Schonbrun 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.
PubMed 30311822Timko 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.
PubMed 30238292Hailemariam 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.
PubMed 29996829
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AA Linkage for Alcohol Abusing Women Leaving Jail
- ClinicalTrials.gov ID
- NCT01970293
- Acronym / sponsor ID
- 1R01AA021732-01A1
- Conditions
- Alcohol Use, AA Attendance, Sexual Risk Behavior
- Keywords
- Alcohol use, STI, Incarcerated women, AA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Introduction to AA volunteer | Other | Other: Introduction to AA volunteer |
| AA materials offered | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introduction to AA volunteerIn-person, in jail introduction to an AA volunteer, who will offer assistance in attending 2 AA meetings. | Other | Introduction to AA volunteer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 32876998Timko 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.
- Derived from this study: PubMed 30311822Schonbrun 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.
- Derived from this study: PubMed 30238292Timko 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.
- Derived from this study: PubMed 29996829Hailemariam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introduction to AA volunteer in people with Alcohol Use and AA Attendance, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of alcohol use days from baseline to 6 months (time frame: Baseline, 1, 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01970293, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.