NCT00183209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

4.6 years

First QC Date

September 13, 2005

Last Update Submit

January 31, 2018

Conditions

Substance Use Disorders

Keywords

Substance use disordersParent child relationship

Outcome Measures

Primary Outcomes (3)

  • Reduction or elimination of alcohol and drug use

    18 months

  • Reduction or elimination of alcohol/drug use problems

    18 months

  • Improvement in parenting behaviors (monitoring, communication, etc)

    18 months

Secondary Outcomes (1)

  • Reduction or elimination of sexual risk behavior

    18 months

Study Arms (2)

14 session behavioral intervention

EXPERIMENTAL

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

Brief Video Intervention

ACTIVE COMPARATOR

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

Behavioral: Family First

Interventions

Family FirstBEHAVIORAL

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.

14 session behavioral interventionBrief Video Intervention

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Injection drug use in the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Development and Research Institutes, Inc

New York, New York, 10010, United States

Location

Related Publications (5)

  • 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.

    PMID: 17613969RESULT

  • 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.

    PMID: 17038756RESULT

  • 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.

    RESULT

  • 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.

    PMID: 17707902RESULT

  • 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

    RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Marya Gwadz, PhD

    National Development and Research Institutes, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

December 1, 2001

Primary Completion

July 1, 2006

Study Completion

January 1, 2008

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

US(1)