SmokingNCT00136279
Linking Lives: Building Quality Parent Components for School-Based Health Programs in Middle Schools
A study testing Linking Lives parent-based intervention in people with Smoking and Sexual Behavior, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate the effectiveness of a parent-based intervention that can be implemented in conjunction with existing school-based programs designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in young adolescents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Smoking, Sexual Behavior
- What is being tested?
- Linking Lives parent-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,510 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Sep 2007
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- African American or Latino
- 6th or 7th grade students
- Residential mothers or primary female caregivers
Who cannot join
- 8th grade students
- Fathers or primary male caregivers
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: RCT of Tobacco Use Prevention and Sexual Risk Reduction Interventions for Parents of African American and Latino Youth in Middle School
The purpose of this study is to develop and evaluate the effectiveness of a parent-based intervention that can be implemented in conjunction with existing school-based programs designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in young adolescents. The parent programs are expected to have effects on adolescent behavior over and above the effects of the school-based programs.
Read the detailed description
Although parent-based programs have shown promise in reducing adolescent risk behavior, few have been rigorously evaluated and shown to be effective. Recruitment and retention of parents into lengthy workshops has been a problem and few programs have been developed specifically for inner-city, minority populations who are at greatest risk for a number of adverse health outcomes. Linking Lives was designed to address these issues.
Parent Intervention. The primary feature of the parent component is a written manual distributed in modules to mothers that teaches them how to communicate effectively with their children about sex or tobacco risk behaviors and how to improve their relationships with their children. This is accompanied by two face-to-face intervention sessions for mothers, during which they are given the intervention materials and an opportunity to participate in role playing activities with other parents, and by regular contact by trained parent volunteers to determine if the parent has implemented the manual contents. Mothers and their adolescents attend Linking Lives events together at the school in the evenings and on weekends during which time adolescents attend their own intervention sessions at the same time mothers are attending theirs (mothers in the control condition participate in sessions on helping their children choose a high school).
Sample. Nine middle schools in the Bronx, New York and two schools in the Harlem neighborhood of New York are participating in the study. The schools are located in communities that are financially disadvantaged. Approximately 70% of the students in the schools are Latino and 30% are African American. A total of 4,750 adolescents and their mothers will participate in the study, 1,900 for tobacco and 2,850 for sexual risk reduction. Students are randomly sampled and their parent is contacted regarding family participation in the study.
Evaluation. Based on input from elicitation studies, focus groups with adolescents and mothers, a pre-intervention survey of 668 mother-adolescent pairs, a psychometric study for both English- and Spanish-language instruments, feedback from community and school leaders, and a scientific panel of experts, the instruments, manuals and intervention protocol have been developed. All measures and intervention materials have been developed in English and in Spanish. The evaluation includes a baseline, 3-month post-test and a 15-month delayed post-test assessment of adolescents and mothers. For tobacco, within schools, students will be randomly assigned to an experimental group (school-based curriculum plus parent component) or a control group (school-based curriculum only). For sexual risk reduction, students will be randomly assigned to the combined experimental condition (school-based curriculum plus parent component), a parent-only experimental condition (parent component is distributed to mothers, but no school component is delivered) or a control group (school-based curriculum only).
- Conditions
- Smoking, Sexual Behavior
- Being tested
- Linking Lives parent-based intervention
- Keywords
- adolescent behavior, sexual behavior, smoking, parents, communication, health education, schools, Sexual initiation
- Medical subject headings
- Smoking, Sexual Behavior, Adolescent Behavior, Communication, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linking Lives parent-based interventionBehavioural
Parent intervention consists of mothers attending two, 2.5 hour-long, face-to-face sessions at the school during which they are given an intervention manual, two homework assignments, and a manual for their adolescent. Parents also receive two booster telephone calls approximately one-month and six-months after completing the intervention. As part of the comparison condition, school-based interventions for adolescents also consist of two, 2.5 hour-long, face-to-face sessions at schools during which they complete either the Project TNT intervention for preventing tobacco use or the Making a Difference intervention for reducing sexual risk behavior.
| Study group | Role | What they receive |
|---|---|---|
| School plus parent | Experimental | Adolescents receive school-based curriculum (either Project TNT or Making a Difference) and mothers receive the Linking Lives curriculum Receives: Behavioral: Linking Lives parent-based intervention |
| School-only | Active comparator | Adolescents receive school-based curriculum and parents received a control curriculum on helping their child choose a high school Receives: Behavioral: Linking Lives parent-based intervention |
| Parent-Only | Experimental | In the sex risk reduction portion of the study only, a second experimental group consisted of parents receiving the Linking Lives intervention and adolescents receiving no in-school intervention Receives: Behavioral: Linking Lives parent-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported ever had sex or ever smoked a cigarette
Measured: 3-month and 15-month follow-up
Secondary outcomes (10)
Intentions to have sex or to smoke cigarettes
Measured: 3-month and 15-month follow-up
Age at first intercourse or first cigarette
Measured: 3-month and 15-month follow-up
Condom use at last sex
Measured: 3-month and 15-month follow-up
Contraceptive use at last sex
Measured: 3-month and 15-month follow-up
Maternal monitoring and supervision
Measured: 3-month and 15-month follow-up
Maternal Communication about smoking cigarettes or sexual intercourse
Measured: 3-month and 15-month follow-up
Quality of maternal communication
Measured: 3-month and 15-month follow-up
Self-reported regular cigarette smoking
Measured: 3-month and 15-month follow-up
Intentions to smoke marijuana
Measured: 3-month and 15-month follow-up
Ever smoked marijuana
Measured: 3-month and 15-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJan 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Columbia University
- Investigators
- Vincent Guilamo-Ramos, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136279
- Sponsor's protocol ID
- CDC-NCCDPHP-3486
- Other IDs
- U87/CCU220155-05
- Status last verified
- Jan 2009
- First submitted
- 25 Aug 2005
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Tobacco Use Prevention and Sexual Risk Reduction Interventions for Parents of African American and Latino Youth in Middle School
- ClinicalTrials.gov ID
- NCT00136279
- Acronym / sponsor ID
- CDC-NCCDPHP-3486
- Conditions
- Smoking, Sexual Behavior
- Keywords
- adolescent behavior, sexual behavior, smoking, parents, communication, health education, schools, Sexual initiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,510 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Columbia University
- Study start
- Jan 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Aug 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 develop and evaluate the effectiveness of a parent-based intervention that can be implemented in conjunction with existing school-based programs designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in young adolescents. The parent programs are expected to have effects on adolescent behavior over and above the effects of the school-based programs.
Detailed description
Although parent-based programs have shown promise in reducing adolescent risk behavior, few have been rigorously evaluated and shown to be effective. Recruitment and retention of parents into lengthy workshops has been a problem and few programs have been developed specifically for inner-city, minority populations who are at greatest risk for a number of adverse health outcomes. Linking Lives was designed to address these issues.
Parent Intervention. The primary feature of the parent component is a written manual distributed in modules to mothers that teaches them how to communicate effectively with their children about sex or tobacco risk behaviors and how to improve their relationships with their children. This is accompanied by two face-to-face intervention sessions for mothers, during which they are given the intervention materials and an opportunity to participate in role playing activities with other parents, and by regular contact by trained parent volunteers to determine if the parent has implemented the manual contents. Mothers and their adolescents attend Linking Lives events together at the school in the evenings and on weekends during which time adolescents attend their own intervention sessions at the same time mothers are attending theirs (mothers in the control condition participate in sessions on helping their children choose a high school).
Sample. Nine middle schools in the Bronx, New York and two schools in the Harlem neighborhood of New York are participating in the study. The schools are located in communities that are financially disadvantaged. Approximately 70% of the students in the schools are Latino and 30% are African American. A total of 4,750 adolescents and their mothers will participate in the study, 1,900 for tobacco and 2,850 for sexual risk reduction. Students are randomly sampled and their parent is contacted regarding family participation in the study.
Evaluation. Based on input from elicitation studies, focus groups with adolescents and mothers, a pre-intervention survey of 668 mother-adolescent pairs, a psychometric study for both English- and Spanish-language instruments, feedback from community and school leaders, and a scientific panel of experts, the instruments, manuals and intervention protocol have been developed. All measures and intervention materials have been developed in English and in Spanish. The evaluation includes a baseline, 3-month post-test and a 15-month delayed post-test assessment of adolescents and mothers. For tobacco, within schools, students will be randomly assigned to an experimental group (school-based curriculum plus parent component) or a control group (school-based curriculum only). For sexual risk reduction, students will be randomly assigned to the combined experimental condition (school-based curriculum plus parent component), a parent-only experimental condition (parent component is distributed to mothers, but no school component is delivered) or a control group (school-based curriculum only).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School plus parent | Experimental | Behavioral: Linking Lives parent-based interventionAdolescents receive school-based curriculum (either Project TNT or Making a Difference) and mothers receive the Linking Lives curriculum |
| School-only | Active comparator | Behavioral: Linking Lives parent-based interventionAdolescents receive school-based curriculum and parents received a control curriculum on helping their child choose a high school |
| Parent-Only | Experimental | Behavioral: Linking Lives parent-based interventionIn the sex risk reduction portion of the study only, a second experimental group consisted of parents receiving the Linking Lives intervention and adolescents receiving no in-school intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- African American or Latino
- 6th or 7th grade students
- Residential mothers or primary female caregivers
Key exclusion criteria (2 listed)
- 8th grade students
- Fathers or primary male caregivers
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 |
|---|---|---|
| Linking Lives parent-based interventionParent intervention consists of mothers attending two, 2.5 hour-long, face-to-face sessions at the school during which they are given an intervention manual, two homework assignments, and a manual for their adolescent. Parents also receive two booster telephone calls approximately one-month and six-months after completing the intervention. As part of the comparison condition, school-based interventions for adolescents also consist of two, 2.5 hour-long, face-to-face sessions at schools during which they complete either the Project TNT intervention for preventing tobacco use or the Making a Difference intervention for reducing sexual risk behavior. | Behavioural | Parent-Only, School plus parent, School-only |
Primary outcome
Self-reported ever had sex or ever smoked a cigarette
Time frame: 3-month and 15-month follow-up
10 secondary outcomes
Intentions to have sex or to smoke cigarettes
Time frame: 3-month and 15-month follow-up
Age at first intercourse or first cigarette
Time frame: 3-month and 15-month follow-up
Condom use at last sex
Time frame: 3-month and 15-month follow-up
Contraceptive use at last sex
Time frame: 3-month and 15-month follow-up
Maternal monitoring and supervision
Time frame: 3-month and 15-month follow-up
Maternal Communication about smoking cigarettes or sexual intercourse
Time frame: 3-month and 15-month follow-up
Quality of maternal communication
Time frame: 3-month and 15-month follow-up
Self-reported regular cigarette smoking
Time frame: 3-month and 15-month follow-up
Intentions to smoke marijuana
Time frame: 3-month and 15-month follow-up
Ever smoked marijuana
Time frame: 3-month and 15-month follow-up
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 3 Feb 2009.
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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.
Vincent Guilamo-Ramos, 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 Linking Lives parent-based intervention in people with Smoking and Sexual Behavior, run by Centers for Disease Control and Prevention 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 2 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 3 Feb 2009. 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?
Self-reported ever had sex or ever smoked a cigarette (time frame: 3-month and 15-month follow-up). 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 3 Feb 2009.