Adolescent BehaviorPhase 3NCT00310258
Drug Use Prevention Among Girls Through a Mother-Daughter Intervention
A Phase 3 study testing Drug use prevention intervention in people with Adolescent Behavior, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
This study will develop and test drug use prevention strategies for low-income, minority girls. Gender-specific substance use rates, risk and protective factors, and health outcomes highlight the need for interventions aimed at 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
- Adolescent Behavior
- What is being tested?
- Drug use prevention intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Feb 2006
- Phase
- Phase 3
- 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
- girls ages 11 to 13 years old at pretest and their mothers who have access to a private computer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University School of Social Work
New York, New York, 10027
About this study
Official title: Drug Abuse Prevention: A Mother-Daughter Intervention
This study will develop and test drug use prevention strategies for low-income, minority girls. Gender-specific substance use rates, risk and protective factors, and health outcomes highlight the need for interventions aimed at girls. Girls and boys share a number of risk factors, yet some factors are more salient for one gender. Girls and boys may also be affected differently by the same risk factors. Intervention planned for this study emphasizes risk and protective factors that impact girls. Our intervention will build mother-daughter communication and closeness; enhance girls' self-efficacy and body esteem; nurture girls' conflict management, problem-solving, stress reduction, and refusal skills; correct perceived norms; build social supports; and establish patterns of parental monitoring and supervision. We hypothesise that girls who receive GSI will have lower 3-year follow-up rates of substance use than girls who receive no intervention.
The study will occur in three phases. In a 12-month preparation phase, we will refine and complete intervention and measurement protocols, recruit subjects and randomly assign girls and mothers to study arms, and pretest girls and mothers. A 12-month implementation phase will initiate field operations of the clinical trial, including intervention delivery, process data collection, and posttests. Follow-up in the last 36 months will involve longitudinal measurements of girls and mothers, booster session development and delivery, and data analyses.
Read the detailed description
The study has two primary and seven secondary aims.
Primary Aims:
- 1. Develop a family-based girl-specific intervention (GSI) to prevent substance use.
- 2. Test the efficacy of GSI.
Secondary Aims:
- 3. Test GSI to improve mediating factors of girls' mother-daughter affective quality, coping, refusal skills, mood management, conflict resolution, problem solving, self-efficacy, body esteem, normative beliefs, social supports, and mother-daughter communication.
- 4. Examine the effects of mediating factors on girls' substance use behavior.
- 5. Test GSI to improve mothers' use of family rituals, rules against substance use, child management, mother-daughter affective quality, and communication with their daughters.
- 6. Examine the effects of mother' outcomes on their daughters' substance use behavior.
- 7. Test the effects of dose on participants' outcomes.
- 8. Determine if GSI has differential outcomes related to ethnic-racial group profile.
- Quantify the costs of intervention development and delivery.
- Conditions
- Adolescent Behavior
- Being tested
- Drug use prevention intervention
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug use prevention interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on substance use behavior at posttest, and annually for 3 years after posttest.
Secondary outcomes (10)
scores on mediating variables at posttest, and annually for 3 years after posttest.
closeness with mother
coping skills
refusal skills
depression (mood)
conflict resolution
problem solving
self-efficacy
body image
normative beliefs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startApr 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven Schinke, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310258
- Sponsor's protocol ID
- girls & drugs
- Other IDs
- 5R01DA017721-02
- Status last verified
- Mar 2006
- First submitted
- 30 Mar 2006
- Last updated
- 11 Jan 2017
- Results posted
- No
Publications
Schinke S, Di Noia J, Schwinn T, Cole K. Drug abuse risk and protective factors among black urban adolescent girls: a group-randomized trial of computer-delivered mother-daughter intervention. Psychol Addict Behav. 2006 Dec;20(4):496-500. doi: 10.1037/0893-164X.20.4.496.
PubMed 17176186
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Abuse Prevention: A Mother-Daughter Intervention
- ClinicalTrials.gov ID
- NCT00310258
- Acronym / sponsor ID
- girls & drugs
- Conditions
- Adolescent Behavior
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2005
- Study completion
- Feb 2006
- First posted
- 3 Apr 2006 (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.
This study will develop and test drug use prevention strategies for low-income, minority girls. Gender-specific substance use rates, risk and protective factors, and health outcomes highlight the need for interventions aimed at girls. Girls and boys share a number of risk factors, yet some factors are more salient for one gender. Girls and boys may also be affected differently by the same risk factors. Intervention planned for this study emphasizes risk and protective factors that impact girls. Our intervention will build mother-daughter communication and closeness; enhance girls' self-efficacy and body esteem; nurture girls' conflict management, problem-solving, stress reduction, and refusal skills; correct perceived norms; build social supports; and establish patterns of parental monitoring and supervision. We hypothesise that girls who receive GSI will have lower 3-year follow-up rates of substance use than girls who receive no intervention.
The study will occur in three phases. In a 12-month preparation phase, we will refine and complete intervention and measurement protocols, recruit subjects and randomly assign girls and mothers to study arms, and pretest girls and mothers. A 12-month implementation phase will initiate field operations of the clinical trial, including intervention delivery, process data collection, and posttests. Follow-up in the last 36 months will involve longitudinal measurements of girls and mothers, booster session development and delivery, and data analyses.
Detailed description
The study has two primary and seven secondary aims.
Primary Aims:
- 1. Develop a family-based girl-specific intervention (GSI) to prevent substance use.
- 2. Test the efficacy of GSI.
Secondary Aims:
- 3. Test GSI to improve mediating factors of girls' mother-daughter affective quality, coping, refusal skills, mood management, conflict resolution, problem solving, self-efficacy, body esteem, normative beliefs, social supports, and mother-daughter communication.
- 4. Examine the effects of mediating factors on girls' substance use behavior.
- 5. Test GSI to improve mothers' use of family rituals, rules against substance use, child management, mother-daughter affective quality, and communication with their daughters.
- 6. Examine the effects of mother' outcomes on their daughters' substance use behavior.
- 7. Test the effects of dose on participants' outcomes.
- 8. Determine if GSI has differential outcomes related to ethnic-racial group profile.
- Quantify the costs of intervention development and delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- girls ages 11 to 13 years old at pretest and their mothers who have access to a private computer
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Drug use prevention intervention | Behavioural | – |
Primary outcome
Scores on substance use behavior at posttest, and annually for 3 years after posttest.
10 secondary outcomes
scores on mediating variables at posttest, and annually for 3 years after posttest.
closeness with mother
coping skills
refusal skills
depression (mood)
conflict resolution
problem solving
self-efficacy
body image
normative beliefs
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 11 Jan 2017.
- Results publication: PubMed 17176186Schinke S, Di Noia J, Schwinn T, Cole K. Drug abuse risk and protective factors among black urban adolescent girls: a group-randomized trial of computer-delivered mother-daughter intervention. Psychol Addict Behav. 2006 Dec;20(4):496-500. doi: 10.1037/0893-164X.20.4.496.
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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 Schinke, Ph.D. 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 Phase 3 study testing Drug use prevention intervention in people with Adolescent Behavior, run by National Institute on Drug Abuse (NIDA) 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 1 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 11 Jan 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Scores on substance use behavior at posttest, and annually for 3 years after posttest.. 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 NCT00310258, which also lists 1 linked publication.
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 11 Jan 2017.