Clinical trial NCT02510209: Evaluation of the Teen Outreach Program in Hennepin County, Minnesota
Official title: Evaluation of the Teen Outreach Program in Hennepin County, Minnesota: Findings From the Replication of an Evidence-Based Teen Pregnancy Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Pregnancy Early
Keywords: Teen pregnancy
Lead sponsor: Abt Associates
Sponsor class: INDUSTRY
Collaborators: name: Hennepin County Human Services and Public Health Department
First posted: 2015-07-29
Enrollment: 1644
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Enrolled in a study teacher's class at the time of the baseline survey
* Active parental consent and youth assent

Exclusion Criteria:

* Inability to complete survey in the languages provided
* Prior participation in TOP

Primary outcomes:
measure: Sex in the last 90 days
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Sex without contraception in the last 90 days
timeFrame: 12 months after baseline
measure: Sex in the last 90 days
timeFrame: 24 months after baseline
measure: Sex without contraception in the last 90 days
timeFrame: 24 months after baseline
measure: Ever had sex
timeFrame: 12 months after baseline
measure: Ever had sex
timeFrame: 24 months after baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Human Services and Public Health Department
state: Minnesota
Study officials:
affiliation: Abt Associates Inc.
name: Kimberly Francis, PhD
role: STUDY_DIRECTOR
References:
citation: Francis, K., Woodford, M., and Kelsey, M. (2015). "Evaluation of the Teen Outreach Program in Hennepin County, MN: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program." Cambridge, MA: Abt Associates Inc.