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
Sexual initiation Smoking	Behavior: Parent-based tobacco use prevention & sexual risk reduction

Further Study Details: 

Primary Outcomes: Self-reported adolescent sexual initiation or tobacco use at 3-month post-test and at 12-month follow-up assessments.
Secondary Outcomes: 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
Expected Total Enrollment:  9510

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 improving class attendance and academic achievement).

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 12-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).

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 8th grade students
• fathers or primary male caregivers

Please refer to this study by ClinicalTrials.gov identifier  NCT00136279

Vincent Guilamo-Ramos, PhD      212-851-1659    rg650@columbia.edu

New York
      Columbia University School of Social Work, New York,  New York,  10027,  United States; Recruiting

Study chairs or principal investigators

Vincent Guilamo-Ramos, PhD,  Principal Investigator,  Columbia University School of Social Work   

Study ID Numbers:  CDC-NCCDPHP-3486; U87/CCU220155-05
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136279
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30