NCT02514811

Brief Summary

The Northwest Coalition for Adolescent Health (NWCAH) replicated the Teen Outreach Program (TOP) in five states across the pacific northwest including Idaho, Alaska, Montana, Oregon, and Washington. The purpose of this study is to measure: at the end of the program year, were TOP students less likely than control group students to report ever being pregnant or causing someone to be pregnant?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,686

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

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, 2011

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3.9 years

First QC Date

July 27, 2015

Last Update Submit

September 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pregnancies

    In the spring at the end of the program year, did the Teen Outreach Program students report significantly fewer pregnancies or births than the students in the Community Voices (the counterfactual) program?

    9 months

Secondary Outcomes (3)

  • Pregnancies at follow up

    21 months

  • Sexual behavior

    9 months

  • Contraceptive use

    9 months

Study Arms (2)

The Teen Outreach Program

EXPERIMENTAL

TOP is a youth development and service learning program for youth 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 months: (1) weekly curriculum sessions, (2) community service learning, and (3) positive adult guidance and support. The TOP Changing Scenes Curriculum is separated into four age-/stage-appropriate levels, Level 1 is typically for youth ages 12 or 13 and Level 4 is typically for youth age 17. The intended program dosage for each participant is a minimum of 25 weekly sessions and at least 20 hours of community service learning over nine months. One or two facilitators, who plan the order of sessions based on the needs and interest of youth, implemented TOP in a group of 10 to 25 youth.

Behavioral: The Teen Outreach Program

Control Group

NO INTERVENTION

Students in the control condition receive a benign intervention called the Community Voices (CV) program, which like TOP, meets in a group setting. The CV students are convened four times during the program year. Sessions are the same length as the TOP sessions. The first and last CV sessions are primarily focused on survey data gathering. At the two other sessions, CV students are convened to discuss current issues among young people in their community. The CV program specifically does not include any sexuality education or community service learning opportunities.

Interventions

Students received the Teen Outreach Program as described previously.

The Teen Outreach Program

Eligibility Criteria

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

You may qualify if:

  • Has parental consent and student assent
  • Attends one of the schools and/or classes chosen for the program

You may not qualify if:

  • Lack of consent or assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Susan Philliber, PhD

    Philliber Research Associates

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 4, 2015

Study Start

September 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 16, 2020

Record last verified: 2020-09