- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02723292
City of Rochester Teen Outreach Program (TOP™) Evaluation
February 8, 2018 updated by: Hugh Crean, University of Rochester
As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers (RCs).
A youth development program with demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has never been studied in RCs.
Advancing from efficacy to effectiveness, the investigators will also measure program fidelity obtained in RCs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1188
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 14 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must be registered at a participating RC
- age 11 through 14 years
- participants must assent and parent(s) or legal guardian(s) provide permission to participate
- basic understanding of the English language
Exclusion Criteria:
- age at enrollment of less than 11 or greater than 14 years
- for facilitators, age less than 21 is an exclusion criterion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group services
This study will replicate the evidence-based TOP™ in after-school sessions held during RC hours.
The primary components of TOP™ include: Comprehensive age-appropriate sexuality education; 90-minute sessions, once a week after-school, during the school year for nine months, using the Changing Scenes© curriculum, and at least twenty hours of youth-led service learning, which involves youth in planning, implementing and reflecting on, community service and leadership.
|
|
ACTIVE_COMPARATOR: Control group services
Youth in the control arm will receive a work readiness training curriculum focused on competencies to secure employment.
This will include such topics as building customer service skills, clear and direct communication, and creating a work portfolio.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who become pregnant
Time Frame: 21 months
|
21 months
|
|
Number of youth who report ever having had sexual intercourse
Time Frame: 21 months
|
For youth who were sexually naive at baseline, the outcome is the number of youth who report ever having had sexual intercourse at the 21 month assessment point.
|
21 months
|
Amount of sexual intercourse in preceding 3 months without an effective means of birth control
Time Frame: 21 months
|
The number of times a youth reports having had sexual intercourse without using an effective means of birth control measured at the 21 month assessment point.
|
21 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of failing grades on report card
Time Frame: 21 months
|
This is a self-report measure of the number of courses failed on the last report card received, measured at the 21 month assessment point.
|
21 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
April 1, 2016
Study Completion (ACTUAL)
April 1, 2016
Study Registration Dates
First Submitted
February 4, 2016
First Submitted That Met QC Criteria
March 23, 2016
First Posted (ESTIMATE)
March 30, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 12, 2018
Last Update Submitted That Met QC Criteria
February 8, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 36508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sex Behavior
-
The University of Hong KongCompletedAdolescent Behavior | Behavior, Sex | Sex, UnsafeHong Kong
-
Eunice Kennedy Shriver National Institute of Child...UnknownAdolescent Behavior | Sex BehaviorUnited States
-
Eunice Kennedy Shriver National Institute of Child...UnknownChild Behavior | Sex BehaviorUnited States
-
University PotiguarUniversidade Federal do Ceará; Federal Institute of Science and Technology...Completed
-
Chinese University of Hong KongRecruiting
-
Centre Hospitalier Universitaire de la RéunionCompleted
-
University Hospital, CaenCompletedSex Behavior | TeenagerFrance
-
Uludag UniversityCompleted
-
Child TrendsPromundo, United States; Latin American Youth CenterCompletedSexual Behavior | Unprotected SexUnited States
-
Child TrendsUniversity of Texas at Austin; EngenderHealth; The Office of Adolescent Health...CompletedSexual Behavior | Unprotected SexUnited States
Clinical Trials on Control intervention
-
National Institute of Environmental Health Sciences...CompletedChild Development | Environmental Exposures | Lead and Injury ReductionUnited States
-
Columbia UniversityNational Institute of Nursing Research (NINR)Recruiting
-
Nova Southeastern UniversityEmory UniversityCompletedDepression | Pain | Sleep Wake Disorders | Fatigue | Chronic DiseaseUnited States
-
Wayne State UniversityCompletedSmoking Reduction | Substance UseUnited States
-
China Medical University HospitalMinistry of Science and Technology, Taiwan; China Medical University, TaiwanUnknownHealth Behavior | Intervention StudyTaiwan
-
University Hospital, MontpellierWithdrawnNREM Parasomnia | Sleepwalking | Sleep TerrorFrance
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingChronic Kidney Diseases | Chronic Disease | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease, Stage 4 (Severe) | Chronic Kidney Disease, Stage 3 (Moderate)United States
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Columbia UniversityCompleted
-
Louis BhererCompleted