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

This study has been completed.
Sponsor:
Collaborator:
Columbia University
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00136279
First received: August 25, 2005
Last updated: January 30, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Smoking
Sexual Behavior
Behavioral: Linking Lives parent-based intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: RCT of Tobacco Use Prevention and Sexual Risk Reduction Interventions for Parents of African American and Latino Youth in Middle School

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Self-reported ever had sex or ever smoked a cigarette [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intentions to have sex or to smoke cigarettes [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Age at first intercourse or first cigarette [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Condom use at last sex [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Contraceptive use at last sex [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Maternal monitoring and supervision [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Maternal Communication about smoking cigarettes or sexual intercourse [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Quality of maternal communication [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Self-reported regular cigarette smoking [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Intentions to smoke marijuana [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]
  • Ever smoked marijuana [ Time Frame: 3-month and 15-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 9510
Study Start Date: January 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
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.
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
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.

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 8th grade students
  • Fathers or primary male caregivers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136279

Locations
United States, New York
Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Vincent Guilamo-Ramos, PhD Columbia University
  More Information

No publications provided

Responsible Party: Vincent Guilamo-Ramos, Columbia University School of Social Work
ClinicalTrials.gov Identifier: NCT00136279     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-3486, U87/CCU220155-05
Study First Received: August 25, 2005
Last Updated: January 30, 2009
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
adolescent behavior
sexual behavior
smoking
parents
communication
health education
schools
Sexual initiation

ClinicalTrials.gov processed this record on August 20, 2014