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

30. Januar 2009 aktualisiert von: Centers for Disease Control and Prevention

RCT of Tobacco Use Prevention and Sexual Risk Reduction Interventions for Parents of African American and Latino Youth in Middle School

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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

9510

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • New York
      • New York, New York, Vereinigte Staaten, 10027
        • Columbia University School of Social Work

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: School plus parent
Adolescents receive school-based curriculum (either Project TNT or Making a Difference) and mothers receive the Linking Lives curriculum
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.
Aktiver Komparator: School-only
Adolescents receive school-based curriculum and parents received a control curriculum on helping their child choose a high school
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
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Self-reported ever had sex or ever smoked a cigarette
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Intentions to have sex or to smoke cigarettes
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Age at first intercourse or first cigarette
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Condom use at last sex
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Contraceptive use at last sex
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Maternal monitoring and supervision
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Maternal Communication about smoking cigarettes or sexual intercourse
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Quality of maternal communication
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Self-reported regular cigarette smoking
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Intentions to smoke marijuana
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up
Ever smoked marijuana
Zeitfenster: 3-month and 15-month follow-up
3-month and 15-month follow-up

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Mitarbeiter

Ermittler

  • Hauptermittler: Vincent Guilamo-Ramos, PhD, Columbia University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2004

Primärer Abschluss (Tatsächlich)

1. September 2007

Studienabschluss (Tatsächlich)

1. September 2007

Studienanmeldedaten

Zuerst eingereicht

25. August 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. August 2005

Zuerst gepostet (Schätzen)

29. August 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

3. Februar 2009

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Januar 2009

Zuletzt verifiziert

1. Januar 2009

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • CDC-NCCDPHP-3486
  • U87/CCU220155-05

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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