Interventions for HIV+ Mothers With Problem Drinking

Substance Use Disorders Clinical Trial

Official title:

Interventions for HIV+ Mothers With Problem Drinking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183209
• Other study ID #: NIAAAGWA12113
• Secondary ID: R01AA012113NIH R
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: January 31, 2018
• Start date: December 2001
• Est. completion date: January 2008

Study information

• Verified date: January 2018
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 2008
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	National Development and Research Institutes, Inc	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
New York University	Beth Israel Medical Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA), St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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, 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. — View Citation

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. Epub 2007 Aug 20. — View Citation

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 alco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction or elimination of alcohol and drug use		18 months
Primary	Reduction or elimination of alcohol/drug use problems		18 months
Primary	Improvement in parenting behaviors (monitoring, communication, etc)		18 months
Secondary	Reduction or elimination of sexual risk behavior		18 months