Evaluation of the Teen Outreach Program in Hennepin County, Minnesota

Sexual Behavior Clinical Trial

Official title:

Evaluation of the Teen Outreach Program in Hennepin County, Minnesota: Findings From the Replication of an Evidence-Based Teen Pregnancy Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510209
• Other study ID #: TP1AH000078
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: July 27, 2015
• Start date: July 2011
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Abt Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1644
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pregnancy Early
• Sexual Behavior

Intervention

Behavioral:
• Teen Outreach Program
TOP® is a youth development and service learning program for youth ages 12 to 17 designed to reduce teenage pregnancy and increase school success by helping youth develop a positive self-image, life management skills, and realistic goals. The TOP® program model consists of three components implemented in school, after school, or in community settings over nine consecutive months: (1) weekly curriculum sessions, (2) community service learning (CSL), and (3) positive adult guidance and support. The TOP® Changing Scenes® curriculum is separated into four age- and stage-appropriate levels, which range from Level 1, typically for youth ages 12 or 13, to Level 4, typically for youth age 17.

Locations

Country	Name	City	State
United States	Hennepin County Human Services and Public Health Department	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Abt Associates	Hennepin County Human Services and Public Health Department

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex in the last 90 days	Single dichotomous item on self-report questionnaire	12 months after baseline	No
Secondary	Sex without contraception in the last 90 days	Single dichotomous item on self-report questionnaire	12 months after baseline	No
Secondary	Sex in the last 90 days	Single dichotomous item on self-report questionnaire	24 months after baseline	No
Secondary	Sex without contraception in the last 90 days	Single dichotomous item on self-report questionnaire	24 months after baseline	No
Secondary	Ever had sex	This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire.	12 months after baseline	No
Secondary	Ever had sex	This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire.	24 months after baseline	No