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Clinical Trial Summary

This study tested the extent to which TOP®, when replicated with fidelity, produced impacts on sexual risk-taking behaviors in the short term and the longer term.


Clinical Trial Description

This is a cluster randomized controlled trial. Teachers were randomized within schools to the treatment and control conditions. To assess the impact of offering TOP®, students were surveyed three times: at baseline, before the intervention began for the treatment group; 12 months after baseline (short-term impacts); and 24 months after baseline (long-term impacts). Baseline data and subsequent follow-up data were collected using a Web-based survey. Paper surveys were used as back-up for baseline data collection. The pooled survey data from two school-year cohorts (school years 2011-2012 and 2012-2013) were used to estimate program impacts using an intent-to-treat (ITT) analysis. Program fidelity and interview data were used to describe program implementation.TOP® was delivered in middle schools, high schools, alternative schools, and public charter schools in Hennepin County. It was implemented during school hours in classes that spanned an entire school year with the same cohort of students. The subject of the class in which TOP® was placed differed across schools (for example, social studies, study hall, health). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02510209
Study type Interventional
Source Abt Associates
Contact
Status Completed
Phase N/A
Start date July 2011
Completion date November 2014

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