Substance Use DisordersNCT00183209
Interventions for HIV+ Mothers With Problem Drinking
A study testing Family First in people with Substance Use Disorders, run by New York University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Family First
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Injection drug use in the past three months
Trial locations and contacts
1 site in 1 country.
United States1 site
National Development and Research Institutes, Inc
New York, New York, 10010
About this study
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Family First
- Keywords
- Substance use disorders, Parent child relationship
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family FirstBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Family First |
| Brief Video Intervention | Active comparator | Single session brief video intervention to build motivation to reduce or eliminate problem drinking/drug use Receives: Behavioral: Family First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction or elimination of alcohol and drug use
Measured: 18 months
Reduction or elimination of alcohol/drug use problems
Measured: 18 months
Improvement in parenting behaviors (monitoring, communication, etc)
Measured: 18 months
Secondary outcomes (1)
Reduction or elimination of sexual risk behavior
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionJul 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), St. Luke's-Roosevelt Hospital Center, Beth Israel Medical Center
- Responsible party
- Sponsor
- Investigators
- Marya Gwadz, PhD, Principal investigator, National Development and Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183209
- Sponsor's protocol ID
- NIAAAGWA12113
- Other IDs
- R01AA012113, NIH R01 AA12113
- Status last verified
- Jan 2018
- First submitted
- 13 Sep 2005
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17613969de 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.
PubMed 17038756Gwadz, 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, 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.
PubMed 17707902Leonard, 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for HIV+ Mothers With Problem Drinking
- ClinicalTrials.gov ID
- NCT00183209
- Acronym / sponsor ID
- NIAAAGWA12113
- Conditions
- Substance Use Disorders
- Keywords
- Substance use disorders, Parent child relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), St. Luke's-Roosevelt Hospital Center, Beth Israel Medical Center
- Study start
- Dec 2001
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14 session behavioral intervention | Experimental | Behavioral: Family First7 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 |
| Brief Video Intervention | Active comparator | Behavioral: Family FirstSingle session brief video intervention to build motivation to reduce or eliminate problem drinking/drug use |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Injection drug use in the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family FirstFamily 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. | Behavioural | 14 session behavioral intervention, Brief Video Intervention |
Primary outcome
Reduction or elimination of alcohol and drug use
Time frame: 18 months
Reduction or elimination of alcohol/drug use problems
Time frame: 18 months
Improvement in parenting behaviors (monitoring, communication, etc)
Time frame: 18 months
1 secondary outcome
Reduction or elimination of sexual risk behavior
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Results publication: PubMed 17613969Leonard 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 publication: PubMed 17038756de 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 publicationGwadz, 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 publication: PubMed 17707902Leonard 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 publicationLeonard, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marya Gwadz, PhD principal investigator
National Development and Research Institutes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family First in people with Substance Use Disorders, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction or elimination of alcohol and drug use (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183209, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.