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Interventions for HIV+ Mothers With Problem Drinking

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family First
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Substance use disorders, Parent child relationship

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Development and Research Institutes, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

14 session behavioral intervention

Brief Video Intervention

Arm Description

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

Single session brief video intervention to build motivation to reduce or eliminate problem drinking/drug use

Outcomes

Primary Outcome Measures

Reduction or elimination of alcohol and drug use
Reduction or elimination of alcohol/drug use problems
Improvement in parenting behaviors (monitoring, communication, etc)

Secondary Outcome Measures

Reduction or elimination of sexual risk behavior

Full Information

First Posted
September 13, 2005
Last Updated
January 31, 2018
Sponsor
New York University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), St. Luke's-Roosevelt Hospital Center, Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00183209
Brief Title
Interventions for HIV+ Mothers With Problem Drinking
Official Title
Interventions for HIV+ Mothers With Problem Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), St. Luke's-Roosevelt Hospital Center, Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Substance use disorders, Parent child relationship

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
14 session behavioral intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Brief Video Intervention
Arm Type
Active Comparator
Arm Description
Single session brief video intervention to build motivation to reduce or eliminate problem drinking/drug use
Intervention Type
Behavioral
Intervention Name(s)
Family First
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction or elimination of alcohol and drug use
Time Frame
18 months
Title
Reduction or elimination of alcohol/drug use problems
Time Frame
18 months
Title
Improvement in parenting behaviors (monitoring, communication, etc)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Reduction or elimination of sexual risk behavior
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marya Gwadz, PhD
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Development and Research Institutes, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17613969
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.
Results Reference
result
PubMed Identifier
17038756
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
17707902
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.
Results Reference
result
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
Results Reference
result

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Interventions for HIV+ Mothers With Problem Drinking

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