CClinicalTrials.gg
CompletedNCT00136279Updated Feb 3, 2009

Linking Lives: Building Quality Parent Components for School-Based Health Programs in Middle Schools

An interventional study of Linking Lives parent-based intervention in Smoking and Sexual Behavior, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2009-02-03.

Sponsored by Centers for Disease Control and Prevention · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
9,510
Allocation
Randomized
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Smoking
  • Sexual Behavior

Keywords

  • adolescent behavior
  • sexual behavior
  • smoking
  • parents
  • communication
  • health education
  • schools
  • Sexual initiation
03

In context

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • African American or Latino
  • 6th or 7th grade students
  • Residential mothers or primary female caregivers

Exclusion criteria

Exclusion Criteria:

  • 8th grade students
  • Fathers or primary male caregivers
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9,510 participants (estimated)

Study arms

  • Experimental
    School plus parent

    Adolescents receive school-based curriculum (either Project TNT or Making a Difference) and mothers receive the Linking Lives curriculum

    Behavioral: Linking Lives parent-based intervention

  • Active comparator
    School-only

    Adolescents receive school-based curriculum and parents received a control curriculum on helping their child choose a high school

    Behavioral: Linking Lives parent-based intervention

  • Experimental
    Parent-Only

    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

    Behavioral: Linking Lives parent-based intervention

Interventions

  • BehavioralLinking Lives parent-based intervention

    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.

06

What researchers measure

Primary outcomes

  1. Self-reported ever had sex or ever smoked a cigarette

    Time frame: 3-month and 15-month follow-up

Secondary outcomes

  1. Intentions to have sex or to smoke cigarettes

    Time frame: 3-month and 15-month follow-up

  2. Age at first intercourse or first cigarette

    Time frame: 3-month and 15-month follow-up

  3. Condom use at last sex

    Time frame: 3-month and 15-month follow-up

  4. Contraceptive use at last sex

    Time frame: 3-month and 15-month follow-up

  5. Maternal monitoring and supervision

    Time frame: 3-month and 15-month follow-up

  6. Maternal Communication about smoking cigarettes or sexual intercourse

    Time frame: 3-month and 15-month follow-up

  7. Quality of maternal communication

    Time frame: 3-month and 15-month follow-up

  8. Self-reported regular cigarette smoking

    Time frame: 3-month and 15-month follow-up

  9. Intentions to smoke marijuana

    Time frame: 3-month and 15-month follow-up

  10. Ever smoked marijuana

    Time frame: 3-month and 15-month follow-up

07

Study locations

1 site
  • Columbia University School of Social Work
    New York, New York 10027, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00136279
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
Columbia University
First posted
Aug 29, 2005
Start date
Jan 2004
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Feb 3, 2009

Study contacts

Vincent Guilamo-Ramos, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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