Clinical trial NCT02540304: Teen Pregnancy Prevention Replication Study
Official title: Teen Pregnancy Prevention Replication Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy
Sexual Risk-taking Behaviors
Lead sponsor: Abt Associates
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
name: Decision Information Resources (DIR)
First posted: 2015-09-03
Enrollment: 7620
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* youth at risk active consent parent permission

Exclusion Criteria:

-

Primary outcomes:
measure: Sexual activity in the last 90 days
timeFrame: 6 months after baseline
measure: Sexual Risk in the last 90 days
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Use of Birth Control in the last 90 days
timeFrame: 6 months after baseline
measure: Knowledge of Sexually transmitted infections
timeFrame: 6 months after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Abt Associates Inc
name: Meredith C Kelsey, PhD
role: PRINCIPAL_INVESTIGATOR
References: