NCT02548871

Brief Summary

The purpose of this study was to determine the impact of TOP® on sexual health behavior.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12,253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

3.8 years

First QC Date

September 10, 2015

Last Update Submit

September 11, 2015

Conditions

Sexual Behavior

Outcome Measures

Primary Outcomes (1)

  • Sex without a condom in the last 90 days

    Dichotomous indicator from self-report survey

    9 months after baseline

Secondary Outcomes (3)

  • Sex in the last 90 days

    9 months after baseline

  • Sex without a condom in the last 90 days, by race/ethnicity

    9 months after baseline

  • Sex without a condom in the last 90 days

    21 months after baseline

Study Arms (2)

Teen Outreach Program

EXPERIMENTAL

Teen Outreach Program

Behavioral: Teen Outreach Program

Comparison

NO INTERVENTION

Business as usual

Interventions

Teen Outreach ProgramBEHAVIORAL

TOP® is a positive youth development and service learning program for youth ages 12 to 17, and its Changing Scenes curriculum is separated into age appropriate levels. The program uses an approach that involves a caring adult, positive self-efficacy, future planning and goal setting and life management skills to to reduce risky sexual behavior and improve school outcomes. TOP® is designed to be delivered in weekly sessions over 9 months and includes community service learning.

Teen Outreach Program

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • First-time 9th grade student
  • Passive parental consent and student assent

You may not qualify if:

  • Inability to complete survey in languages provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Seshadri R, Smithgall C, Goerge R, Ippolito J, Dasgupta D, Wiegand E, Guiltinan S, Wood M. (2015) Evaluation of the Teen Outreach Program: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program. Chicago, IL: Chapin Hall at the University of Chicago

    BACKGROUND

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 14, 2015

Study Start

September 1, 2010

Primary Completion

June 1, 2014

Study Completion

August 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-09