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Interventions for HIV+ Mothers With Problem Drinking
This study has been completed.
Sponsor:
New York University
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
St. Luke's-Roosevelt Hospital Center
Beth Israel Medical Center
Information provided by:
New York University
ClinicalTrials.gov Identifier:
NCT00183209
First received: September 13, 2005
Last updated: April 29, 2010
Last verified: October 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Substance Use Disorders | Behavioral: Family First | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Interventions for HIV+ Mothers With Problem Drinking |
Resource links provided by NLM:
Further study details as provided by New York University:
Primary Outcome Measures:
- Reduction or elimination of alcohol and drug use [ Time Frame: 18 months ]
- Reduction or elimination of alcohol/drug use problems [ Time Frame: 18 months ]
- Improvement in parenting behaviors (monitoring, communication, etc) [ Time Frame: 18 months ]
Secondary Outcome Measures:
- Reduction or elimination of sexual risk behavior [ Time Frame: 18 months ]
| Enrollment: | 118 |
| Study Start Date: | December 2001 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Behavioral: Family First
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
|
Behavioral: Family First
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.
|
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.
Eligibility| Ages Eligible for Study: | 11 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183209
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183209
Locations
| United States, New York | |
| National Development and Research Institutes, Inc | |
| New York, New York, United States, 10010 | |
Sponsors and Collaborators
New York University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
St. Luke's-Roosevelt Hospital Center
Beth Israel Medical Center
Investigators
| Principal Investigator: | Marya Gwadz, PhD | National Development and Research Institutes, Inc. |
More Information
Publications:
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, 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
| Responsible Party: | Joe Hayes, New York University, Office of Sponsored Programs |
| ClinicalTrials.gov Identifier: | NCT00183209 History of Changes |
| Other Study ID Numbers: |
NIAAAGWA12113 R01AA012113 ( U.S. NIH Grant/Contract ) NIH R01 AA12113 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 29, 2010 |
Keywords provided by New York University:
|
Substance use disorders Parent child relationship |
Additional relevant MeSH terms:
|
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
ClinicalTrials.gov processed this record on July 21, 2017