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
  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
Endpoint Classification: Efficacy Study
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 ] [ 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 ]

Secondary Outcome Measures:
  • Reduction or elimination of sexual risk behavior [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
United States, New York
National Development and Research Institutes, Inc
New York, New York, United States, 10010
Sponsors and Collaborators
New York University
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, NIH R01 AA12113
Study First Received: September 13, 2005
Last Updated: April 29, 2010
Health Authority: United States: Federal Government

Keywords provided by New York University:
Substance use disorders
Parent child relationship

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 10, 2014