NCT00136279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,510

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 3, 2009

Status Verified

January 1, 2009

Enrollment Period

3.7 years

First QC Date

August 25, 2005

Last Update Submit

January 30, 2009

Conditions

SmokingSexual Behavior

Keywords

adolescent behaviorsexual behaviorsmokingparentscommunicationhealth educationschoolsSexual initiation

Outcome Measures

Primary Outcomes (1)

  • Self-reported ever had sex or ever smoked a cigarette

    3-month and 15-month follow-up

Secondary Outcomes (10)

  • Intentions to have sex or to smoke cigarettes

    3-month and 15-month follow-up

  • Age at first intercourse or first cigarette

    3-month and 15-month follow-up

  • Condom use at last sex

    3-month and 15-month follow-up

  • Contraceptive use at last sex

    3-month and 15-month follow-up

  • Maternal monitoring and supervision

    3-month and 15-month follow-up

  • +5 more secondary outcomes

Study Arms (3)

School plus parent

EXPERIMENTAL

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

School-only

ACTIVE COMPARATOR

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-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

Behavioral: Linking Lives parent-based intervention

Interventions

Linking Lives parent-based interventionBEHAVIORAL

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.

Parent-OnlySchool plus parentSchool-only

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • th grade students
  • Fathers or primary male caregivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University School of Social Work

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

SmokingSexual BehaviorAdolescent BehaviorCommunicationHealth Education

Condition Hierarchy (Ancestors)

BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Vincent Guilamo-Ramos, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

January 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 3, 2009

Record last verified: 2009-01

Locations

US(1)