NCT02510209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,644

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

July 27, 2015

Last Update Submit

July 27, 2015

Conditions

Keywords

Teen pregnancy

Outcome Measures

Primary Outcomes (1)

  • Sex in the last 90 days

    Single dichotomous item on self-report questionnaire

    12 months after baseline

Secondary Outcomes (5)

  • Sex without contraception in the last 90 days

    12 months after baseline

  • Sex in the last 90 days

    24 months after baseline

  • Sex without contraception in the last 90 days

    24 months after baseline

  • Ever had sex

    12 months after baseline

  • Ever had sex

    24 months after baseline

Study Arms (2)

Teen Outreach Program

EXPERIMENTAL
Behavioral: Teen Outreach Program

Control

NO INTERVENTION

Business as usual.

Interventions

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.

Teen Outreach Program

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Human Services and Public Health Department

Minneapolis, Minnesota, 55415, United States

Location

Related 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.

    RESULT

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kimberly Francis, PhD

    Abt Associates Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 29, 2015

Study Start

July 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations