Interventions for HIV+ Mothers With Problem Drinking
January 31, 2018 updated by: New York University
The purpose of this study is to evaluate the efficacy of a 14-session behavioral intervention for HIV-infected and uninfected mothers with problem drinking.
The intervention targets alcohol and drug problems, sexual risk behavior, and parenting.
We hypothesize that mothers in the 14-session intervention condition will show improvements in alcohol and drug use, sexual risk behavior, and parenting in comparison to the control condition, which receives a one session brief video intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the efficacy of a 14-session behavioral intervention for HIV-infected and uninfected mothers with problem drinking.
We targeted 118 mothers of adolescent children (aged 11-18).
The intervention is based on Social Action Theory (Ewart, 1991) and targets alcohol and drug problems, sexual risk behavior, and parenting.
Mothers are followed and interviewed at four intervals over 18 months.
Because we anticipate that the intervention will have effects on adolescent behavior, these youth are also enrolled and interviewed at three intervals over 12 months.
Adolescents do not attend intervention sessions.
We hypothesize that mothers in the 14-session intervention condition will show improvements in alcohol and drug use, sexual risk behavior, and parenting in comparison to the control condition, which receives a one session brief video intervention.
Study Type
Interventional
Enrollment (Actual)
118
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
-
-
New York
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New York, New York, United States, 10010
- National Development and Research Institutes, Inc
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-
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
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for adult participants (mothers):
- Age over 18
- Meets criteria for problem drinking on the AUDIT (score of 6 or greater)
- Has one biological/adopted child aged 11-18 who was in the home at least half the time in the past month
Exclusion Criteria:
- Injection drug use in the past three months
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 14 session behavioral intervention
7 sessions addressing problem alcohol and drug use and 7 session addressing parenting challenges (monitoring, negotiation, etc) based on based on Social Action Theory (Ewart, 1991) and Motivational Interviewing
|
Family First = 14 sessions lasting 1.5 hours each based on Social Action Theory and Motivational Interviewing (7 sessions on reducing alcohol and drug use and 7 sessions on reducing parenting challenges).
Brief Video Intervention was a single session designed to increase motivation to reduce/eliminate problem drinking or drug use.
|
|
Active Comparator: Brief Video Intervention
Single session brief video intervention to build motivation to reduce or eliminate problem drinking/drug use
|
Family First = 14 sessions lasting 1.5 hours each based on Social Action Theory and Motivational Interviewing (7 sessions on reducing alcohol and drug use and 7 sessions on reducing parenting challenges).
Brief Video Intervention was a single session designed to increase motivation to reduce/eliminate problem drinking or drug use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction or elimination of alcohol and drug use
Time Frame: 18 months
|
18 months
|
|
Reduction or elimination of alcohol/drug use problems
Time Frame: 18 months
|
18 months
|
|
Improvement in parenting behaviors (monitoring, communication, etc)
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction or elimination of sexual risk behavior
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marya Gwadz, PhD, National Development and Research Institutes, Inc.
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
- Leonard NR, Gwadz MV, Cleland CM, Rotko L, Gostnell K. Physical and mental health functioning of urban HIV-infected and uninfected mothers with problem drinking. Am J Drug Alcohol Abuse. 2007;33(3):419-27. doi: 10.1080/00952990701313652.
- de Guzman R, Leonard NR, Gwadz MV, Young R, Ritchie AS, Arredondo G, Riedel M. "I thought there was no hope for me": a behavioral intervention for urban mothers with problem drinking. Qual Health Res. 2006 Nov;16(9):1252-66. doi: 10.1177/1049732306294080.
- Gwadz, MV, Leonard, NL, Cleland, C, Riedel, M, Arredondo, G, Wolfe, H, Hardcastle, E, & Morris, J. Behavioral interventions for HIV infected and uninfected mothers with problem drinking. Addiction Research and Theory 16(1): 47-65, 2008.
- Leonard NR, Gwadz MV, Cleland CM, Vekaria PC, Ferns B. Maternal substance use and HIV status: adolescent risk and resilience. J Adolesc. 2008 Jun;31(3):389-405. doi: 10.1016/j.adolescence.2007.07.001. Epub 2007 Aug 20.
- Leonard, N. R., Gwadz, M. V., Arredondo, G. N., Riedel, M., Rotko, L., Hardcastle, E. J., Potere, J. C. (2007). Description of a behavioral intervention to reduce substance use and related risk and increase positive parenting among urban mothers with alcohol and other drug problems. Journal of Child and Family Studies, 16(4):531-544
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
December 1, 2001
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
January 31, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAAGWA12113
- R01AA012113 (U.S. NIH Grant/Contract)
- NIH R01 AA12113
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