ClinicalTrials.gov
ClinicalTrials.gov Menu

Interventions for HIV+ Mothers With Problem Drinking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00183209
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 2, 2018
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
St. Luke's-Roosevelt Hospital Center
Beth Israel Medical Center
Information provided by (Responsible Party):
New York University

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Family First Not Applicable

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 Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventions for HIV+ Mothers With Problem Drinking
Study Start Date : December 2001
Actual Primary Completion Date : July 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Parenting
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
 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.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Reduction or elimination of alcohol and drug use [ Time Frame: 18 months ]
  2. Reduction or elimination of alcohol/drug use problems [ Time Frame: 18 months ]
  3. Improvement in parenting behaviors (monitoring, communication, etc) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Reduction or elimination of sexual risk behavior [ Time Frame: 18 months ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:
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: New York University
ClinicalTrials.gov Identifier: NCT00183209     History of Changes
Other Study ID Numbers: NIAAAGWA12113
R01AA012113 ( U.S. NIH Grant/Contract )
NIH R01 AA12113
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders