NCT02514759

Brief Summary

The Women's Clinic of Kansas City (TWC) replicated the Teen Outreach Program (TOP) across Kansas City, Missouri. The purpose of this study is to measure: one year after the end of the program year, what is TOP's impact on the treatment group's sexual activity and contraceptive use, relative to the control group, at one year following the program?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,885

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration 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, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
4 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

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

July 28, 2015

Last Update Submit

April 29, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sexual activity

    TOP's impact on the treatment group's sexual activity, relative to the control group, as measured by the questions "have you ever had sex" and "have you had sexual intercourse in the past three months".

    One year after the program (21 months)

  • Contraceptive use

    TOP's impact on the treatment group's contraception use, relative to the control group, as measured by the question "have you had sexual intercourse in the past three months without using any method of birth control" and "have you had sexual intercourse in the past three months without using a condom".

    One year after the program (21 months)

Secondary Outcomes (2)

  • Grades

    One year after the program (21 months)

  • School suspensions

    One year after the program (21 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 (one per week at 40-50 minutes each) 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

The control group received business as usual.

Interventions

Students received the Teen Outreach Program as described previously.

The Teen Outreach Program

Eligibility Criteria

Age10 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 28, 2015

First Posted

August 4, 2015

Study Start

September 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 1, 2020

Record last verified: 2020-04