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

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ClinicalTrials.gov Identifier: NCT00136279
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : February 3, 2009
Sponsor:
Collaborator:
Columbia University
Information provided by:
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date February 3, 2009
Study Start Date  ICMJE January 2004
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
Self-reported ever had sex or ever smoked a cigarette [ Time Frame: 3-month and 15-month follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
Self-reported adolescent sexual initiation or tobacco use at 3-month post-test and at 12-month follow-up assessments.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
  • Intentions to have sex and to smoke cigarettes at 3 & 12 mos
  • Age at first intercourse or first cigarette at 3 & 12 mos
  • Condom use at 3 & 12 mos
  • Contraceptive use at 3 & 12 mos
  • Pregnancy at 3 & 12 mos
  • Frequency of intercourse at 3 & 12 mos
  • Maternal communication about sex or smoking at 3 & 12 mos
  • Regular cigarette smoking at 3 & 12 mos
  • Frequency of cigarette smoking (past 30 days) at 3 & 12 mos
  • Lifetime cigarette smoking frequency at 3 & 12 mos
  • Quitting smoking at 3 & 12 mos
  • Intentions to smoke marijuana at 3 & 12 mos
  • Initiation of marijuana use at 3 & 12 mos
  • Frequency of marijuana use (past 30 days, past 12 mos) at 3 & 12 mos
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Linking Lives: Building Quality Parent Components for School-Based Health Programs in Middle Schools
Official Title  ICMJE RCT of Tobacco Use Prevention and Sexual Risk Reduction Interventions for Parents of African American and Latino Youth in Middle School
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Smoking
  • Sexual Behavior
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: School plus parent
    Adolescents receive school-based curriculum (either Project TNT or Making a Difference) and mothers receive the Linking Lives curriculum
    Intervention: 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
    Intervention: 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
    Intervention: Behavioral: Linking Lives parent-based intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 26, 2005)
9510
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136279
Other Study ID Numbers  ICMJE CDC-NCCDPHP-3486
U87/CCU220155-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vincent Guilamo-Ramos, Columbia University School of Social Work
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE Columbia University
Investigators  ICMJE
Principal Investigator: Vincent Guilamo-Ramos, PhD Columbia University
PRS Account Centers for Disease Control and Prevention
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP