Substance UseNCT01236248
Drug Abuse Prevention Among Girls Through a Mother-Daughter Intervention
A study testing Prevention in people with Substance Use, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine a computer- and family-based drug abuse prevention program is able to reduce drug use among early adolescent girls. Read more about this study
- Who is it for?
- Ages 11 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to 4 Oct 2012
- 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 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- English-speaking New York City (NYC) area girls
- Ages 11 - 13 years
- Must have private access to a computer with high-speed connectivity
Who cannot join
- Non-English-speaking girls who do not live in the NYC area
- Younger than 11 or older than 13 years of age
- Those who lack of private access to a computer with high-speed connectivity
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine a computer- and family-based drug abuse prevention program is able to reduce drug use among early adolescent girls.
Read the detailed description
This study longitudinally tested a computerized, parent-involvement substance abuse prevention program for adolescent girls and their mothers. The prevention program aimed to strengthen and sustain the mother-daughter bond while equipping girls with the necessary information and skills to increase protective factors and reduce risk factors associated with tobacco, alcohol, and other harmful substance use.
- Conditions
- Substance Use
- Being tested
- Prevention
- Keywords
- drugs, youth, parent, computer, prevention
- 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.
PreventionBehavioural
9-session computerized cognitive behavioral program that young girls and their mothers interact with on a weekly basis in the privacy of their home. Girls and their mothers will watch and interact with 10 compact disc (CD) intervention sessions to learn skills to help girls avoid substance use.
| Study group | Role | What they receive |
|---|---|---|
| Prevention Program | Experimental | Girls and their mothers who are assigned to participate in a tobacco, alcohol, and other drug use prevention program aimed at young girls. Receives: Behavioral: Prevention |
| No Prevention Program | No intervention | Girls and their mothers who are assigned to participate in questionnaires only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Substance Use
Measured 30-day alcohol, tobacco, and other illicit drug use among girls.
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startDec 2004
- Primary completionMar 2010
- Study completion4 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 916 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Steven P Schinke, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236248
- Sponsor's protocol ID
- AAAB2130
- Other IDs
- R01DA017721
- Status last verified
- Jul 2017
- First submitted
- 5 Nov 2010
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Abuse Prevention Among Girls Through a Mother-Daughter Intervention
- ClinicalTrials.gov ID
- NCT01236248
- Acronym / sponsor ID
- AAAB2130
- Conditions
- Substance Use
- Keywords
- drugs, youth, parent, computer, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 916 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- 4 Oct 2012 (actual)
- First posted
- 8 Nov 2010 (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 determine a computer- and family-based drug abuse prevention program is able to reduce drug use among early adolescent girls.
Detailed description
This study longitudinally tested a computerized, parent-involvement substance abuse prevention program for adolescent girls and their mothers. The prevention program aimed to strengthen and sustain the mother-daughter bond while equipping girls with the necessary information and skills to increase protective factors and reduce risk factors associated with tobacco, alcohol, and other harmful substance use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention Program | Experimental | Behavioral: PreventionGirls and their mothers who are assigned to participate in a tobacco, alcohol, and other drug use prevention program aimed at young girls. |
| No Prevention Program | No intervention | –Girls and their mothers who are assigned to participate in questionnaires only. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- English-speaking New York City (NYC) area girls
- Ages 11 - 13 years
- Must have private access to a computer with high-speed connectivity
Key exclusion criteria (3 listed)
- Non-English-speaking girls who do not live in the NYC area
- Younger than 11 or older than 13 years of age
- Those who lack of private access to a computer with high-speed connectivity
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 |
|---|---|---|
| Prevention9-session computerized cognitive behavioral program that young girls and their mothers interact with on a weekly basis in the privacy of their home. Girls and their mothers will watch and interact with 10 compact disc (CD) intervention sessions to learn skills to help girls avoid substance use. | Behavioural | Prevention Program |
Primary outcome
Rate of Substance Use
Time frame: Annually
Measured 30-day alcohol, tobacco, and other illicit drug use among girls.
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 18 Jul 2017.
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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.
Steven P Schinke, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention in people with Substance Use, run by Columbia 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 3 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 18 Jul 2017. 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?
Rate of Substance Use (time frame: Annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2017.