Teen Pregnancy Prevention Replication Study

Study Overview
=================
Brief Summary
-----------------
This study is evaluating the effectiveness of three evidence-based teen pregnancy prevention (TPP) programs in reducing sexual risk-taking behaviors of youth. The study is using an experimental design in which youth are randomly assigned to receive either TPP programming or services as usual.

Detailed Description
-----------------
The Teen Pregnancy Prevention Replication Study is being conducted under contract for the U.S. Department of Health and Human Services (DHHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) and Office of Adolescent Health (OAH) by Abt Associates and its subcontractors, Belmont Research Associates, and Decision Information Resources (DIR). The study seeks to add to the knowledge base about effective teen pregnancy prevention programs by examining replications of evidence-based program models currently funded through the Teen Pregnancy Prevention program, administered by OAH. Through a series of rigorous experimental design evaluations, the study will test multiple replications of three widely-used evidence-based program models to determine their effectiveness across different settings and populations. This strategy of selecting multiple replications of each program model will allow for an examination of variation in impacts across replications for each program model and provide evidence about the generalizability of program effectiveness. A comprehensive implementation study will provide information about the contexts in which evidence-based programs are implemented, the challenges faced in implementing them, and the aspects of program implementation that are associated with program impacts. The models that will be examined in this study include: ¡Cuidate! (an HIV/STI risk reduction program); Reducing the Risk (a sexuality education curriculum); and Safer Sex (a clinic-based HIV/STI prevention program for high-risk adolescent females). Program impacts will be estimated by using an experimental design in which youth are randomly assigned to treatment and control conditions. The unit of random assignment will be the individual or school class, depending upon the program setting. Overall, the study will be based on a sample of approximately 8,000 youth in nine locations across the country. The evaluation team will collect baseline information when youth are enrolled in the program, short-term outcome data at a follow-up survey between 6 and 12 months post-random assignment, and longer-term outcome data at a follow-up survey administered between 18 and 24 months post-random assignment. Comparison of outcomes for program and control groups will provide important information about the effectiveness of the programs in reducing teen pregnancy and associated risk behaviors.

Official Title
-----------------
Teen Pregnancy Prevention Replication Study

Conditions
-----------------
Teen Pregnancy, Sexual Risk-taking Behaviors

Intervention / Treatment
-----------------
* Behavioral: Reducing the Risk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: youth at risk active consent parent permission Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPP program<br>Reducing the Risk, Safer Sex Intervention, Cuidate! | Behavioral: Reducing the Risk<br>* Safer Sex is a clinic-based intervention intended to reduce the incidence of STIs and increase condom use among high-risk sexually active female adolescents and delivered in face-to-face individualized sessions by a female health educator. Reducing the Risk is a sexuality-education curriculum, most often delivered in a school setting that provides instruction and practice in the social skills needed to put into action what students learn about preventing pregnancy and reducing unsafe behavior in future high-risk situations. ¡Cuidate! is adapted from the Be Proud! Be Responsible! curriculum and culturally tailored for Latino youth. It aims to reduce HIV risk and unintended pregnancies by affecting sexual behaviors such as intercourse, number of partners, and condom use.<br>* Other names: Cuidate!;|
| No Intervention: Business as Usual<br>Business as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual activity in the last 90 days | single dichotomous outcome on self-report questionnaire | 6 months after baseline | 
| Sexual Risk in the last 90 days | single dichotomous outcome on self-report questionnaire | 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Birth Control in the last 90 days | single dichotomous outcome on self-report questionnaire | 6 months after baseline | 
| Knowledge of Sexually transmitted infections | Average of 12 dichotomous items on self-report questionnaire | 6 months after baseline |