Interventions for HIV+ Mothers With Problem Drinking

This study has been completed.
Sponsor:
Collaborators:
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

September 13, 2005
April 29, 2010
December 2001
July 2006   (final data collection date for primary outcome measure)
  • Reduction or elimination of alcohol and drug use [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Reduction or elimination of alcohol/drug use problems [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Improvement in parenting behaviors (monitoring, communication, etc) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • - Reduction or elimination of alcohol and drug use
  • - Reduction or elimination of alcohol/drug use problems
  • - Improvement in parenting behaviors (monitoring, communication, etc)
Complete list of historical versions of study NCT00183209 on ClinicalTrials.gov Archive Site
Reduction or elimination of sexual risk behavior [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Reduction or elimination of sexual risk behavior
Not Provided
Not Provided
 
Interventions for HIV+ Mothers With Problem Drinking
Interventions for HIV+ Mothers With Problem Drinking

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Substance Use Disorders
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.
  • 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
    Intervention: Behavioral: Family First
  • Active Comparator: Brief Video Intervention
    Single session brief video intervention to build motivation to reduce or eliminate problem drinking/drug use
    Intervention: Behavioral: Family First

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
January 2008
July 2006   (final data collection date for primary outcome measure)

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
Both
11 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183209
NIAAAGWA12113, R01AA012113, NIH R01 AA12113
No
Joe Hayes, New York University, Office of Sponsored Programs
New York University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • St. Luke's-Roosevelt Hospital Center
  • Beth Israel Medical Center
Principal Investigator: Marya Gwadz, PhD National Development and Research Institutes, Inc.
New York University
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP