Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02548871
Other study ID # TP1AH000066
Secondary ID
Status Completed
Phase N/A
First received September 10, 2015
Last updated September 11, 2015
Start date September 2010
Est. completion date August 2015

Study information

Verified date September 2015
Source Chapin Hall Center for Children
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Description:

The cluster-randomized study was conducted in 9th grade classrooms in Chicago Public Schools (CPS) with equal number of schools randomized to intervention and comparison groups for two cohort years. Students were administered a scannable paper survey at three time points: baseline, post-program and 1-year post program. The primary impact analysis used an intent-to-treat approach. Implementation of TOPĀ® was assessed by conducting classroom observations. TOPĀ® was delivered in a variety of classroom settings over the school year by facilitators from CPS and partner organizations.


Recruitment information / eligibility

Status Completed
Enrollment 12253
Est. completion date August 2015
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- First-time 9th grade student

- Passive parental consent and student assent

Exclusion Criteria:

- Inability to complete survey in languages provided

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Teen Outreach Program
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Chapin Hall Center for Children Chicago Public Schools

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary Sex without a condom in the last 90 days Dichotomous indicator from self-report survey 9 months after baseline No
Secondary Sex in the last 90 days Dichotomous indicator from self-report survey 9 months after baseline No
Secondary Sex without a condom in the last 90 days, by race/ethnicity Dichotomous indicator from self-report survey 9 months after baseline No
Secondary Sex without a condom in the last 90 days Dichotomous indicator from self-report survey 21 months after baseline No
See also
  Status Clinical Trial Phase
Completed NCT02493647 - Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk N/A
Completed NCT03533192 - Replication of Evidence-based Programs N/A
Completed NCT00220597 - Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse N/A
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Completed NCT04035694 - Evaluation Study of the Online High School Media Aware Program N/A
Completed NCT04070950 - Sexuality of Women With Pelvic Cancer
Completed NCT04079608 - Rigorous Evaluation of High School FLASH N/A
Completed NCT03366636 - Project Legacy Impact Evaluation Study N/A
Completed NCT02613039 - Oral Contraceptive Therapy and Sexuality Phase 4
Completed NCT02736214 - Reproductive Life Plan-based Counseling With Men N/A
Withdrawn NCT01169922 - HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response N/A
Completed NCT00249496 - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1 N/A
Completed NCT02993185 - Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention N/A
Active, not recruiting NCT01088542 - The Community Youth Development Study: A Test of Communities That Care N/A
Completed NCT03330522 - Reducing HIV Risk in Urban Women: Soap Opera Videos on Video-Capable Cell Phones N/A
Completed NCT02530645 - Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults N/A
Completed NCT02866292 - The Pelvic Floor Muscles Strength and Sexual Function in Primigravid and Non-pregnant Nulliparous N/A
Completed NCT00109421 - Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females N/A
Recruiting NCT05140980 - Sexuality Education: Knowledge of Women Aged 18 to 25
Completed NCT04962802 - Evaluation of Manhood 2.0: A Community-Based Teen Pregnancy Prevention Program for Young Men N/A