- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00059241
The "Reach For Health" Program: Delaying Sexual Activity in Children
Reach For Health--Middle Childhood Risk Prevention Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Given the early age of sexual initiation among urban minority youth, interventions aimed at reducing sexual initiation and risky sexual behavior related to HIV and other sexually transmitted infections (STIs) should begin prior to entry into middle school. These interventions should support both students and their parents through the transition to early adolescence. In collaboration with the New York City Public Schools, this study is designed to evaluate strategies to prevent early sexual initiation and its precursors among academically at-risk urban minority boys and girls.
This study will answer two questions: 1) do factors that predict sexual risk taking and its precursors in young adolescence operate similarly in middle childhood; and 2) can interventions shown to be effective in early adolescence be developmentally adapted for middle childhood to delay sexual initiation and its precursors? The study will evaluate the impact of the intervention on mechanisms hypothesized to reduce sexual risk taking and its precursors, including the personal resiliency and social competencies of youth. The study will also collect data on the costs and process of implementation to inform subsequent dissemination.
Participants in this study will be fifth and sixth grade children enrolled in participating public schools in Brooklyn, NY. Participating school communities will be predominantly African American and Latino. In the fall of their fifth and sixth grade years, students and their families are assigned at random to participate in either a parent education group or in a control group. The parent education program, "Saving Sex for Later," focuses on the transition from middle childhood to early adolescence, the pressures to engage in risk behaviors (including early sexual initiation and related risks), and peer and parental influences on youth attitudes and behaviors. Those in the control condition receive a classroom health curriculum. In addition, a subgroup in each grade level is assigned to participate in service learning, an educational method in which personal and community values are taught through experience in structured service activities.
Youth will be followed for 12 to 18 months. Surveys will be conducted in the fall of the fifth and sixth grade years and again at a 3-month post intervention follow-up. These surveys will measure youth attitudes and behaviors, including precursors to early sexual initiation and related risk behaviors. Surveys of parents' attitudes and behaviors will also be conducted to supplement information from youth. To assist in interpreting results of the surveys, in-depth qualitative interviews will be conducted with a subgroup of fifth grade youth; these youth will be resurveyed prior to entry into seventh grade.
Tipo di studio
Iscrizione
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Newton, Massachusetts, Stati Uniti, 02458
- Reclutamento
- Education Development Center, Inc.
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Contatto:
- Lydia O'Donnell, Ed.D.
- Numero di telefono: 2368 617-969-7100
- Email: lodonnell@edc.org
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria
- Youth attending NYC schools implementing "Reach for Health" program components and their parents
- Enrolled in general education classes
- Ability to complete survey assessments in English
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Collaboratori e investigatori
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 5R01HD39537-2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .