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Replication of Evidence-based Programs

NCT03533192 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2588

Last updated 2018-05-23

No results posted yet for this study

Summary

The purpose of this school-level randomized intervention trial is to evaluate the It's Your Game…Keep It Real program, an evidence-based teen pregnancy, HIV, and STI prevention program, among 2,000 students from 20 middle schools in 10 participating school districts in Harris County and surrounding areas. An audio computer-assisted self interview (A-CASI) assessment was used to assess demographic characteristics, psychosocial factors, sexual behaviors, and program exposure at three data collection points. Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.

Conditions

  • Sexual Behavior

Interventions

BEHAVIORAL

It's Your Game...Keep it Real

It's Your Game...Keep it Real consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). In each grade, the curriculum integrates group-based classroom activities with personalized journaling and individually tailored computer-based activities. A life-skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal rules regarding risk behaviors, detect signs or situations that might challenge these rules, and use refusal skills and other tactics to protect these rules. The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models.

Sponsors & Collaborators

  • ETR Associates

    collaborator OTHER

  • The Office of Adolescent Health, HHS

    collaborator FED

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Susan T Emery, PhD · UT School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533192 on ClinicalTrials.gov