Clinical trial NCT00183209: Interventions for HIV+ Mothers With Problem Drinking
Official title: Interventions for HIV+ Mothers With Problem Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Substance use disorders
Parent child relationship
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: St. Luke's-Roosevelt Hospital Center
name: Beth Israel Medical Center
First posted: 2005-09-16
Enrollment: 118
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Reduction or elimination of alcohol and drug use
timeFrame: 18 months
measure: Reduction or elimination of alcohol/drug use problems
timeFrame: 18 months
measure: Improvement in parenting behaviors (monitoring, communication, etc)
timeFrame: 18 months
Secondary outcomes:
measure: Reduction or elimination of sexual risk behavior
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: National Development and Research Institutes, Inc
state: New York
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: Marya Gwadz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/00952990701313652.
citation: 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. doi: 10.1177/1049732306294080.
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.
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. doi: 10.1016/j.adolescence.2007.07.001. Epub 2007 Aug 20.
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 alcohol and other drug problems. Journal of Child and Family Studies, 16(4):531-544