Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 11:51 PM
Study NCT ID:
NCT03533192
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2018-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Replication of Evidence-based Programs
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Teenage Pregnancy Prevention: Replication of Evidence-based Programs
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Program Implemented: It's Your Game…Keep It Real (IYG) 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). The intervention was provided to the same 7th and 8th graders over a two-year period (i.e., the same students receive up to 24 lessons over two years). The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models. The lessons were delivered according to the schedule that worked best for schools (for example, twice a week, once a week, or daily) within a school semester. The lessons were delivered by trained teachers during regular classroom time and were taught during a variety of subject areas (for example, physical education/health, social studies, and science). Teachers implementing the lessons were required to attend training in order to teach the 7th- and 8th-grade lessons.
Sample: This sample included students at 20 schools from selected school districts throughout the greater Houston, Texas, area that agreed to participate in the study and that served 7th and 8th grades. Student inclusion criteria required that students not face language barriers or require educational accommodations that would preclude them from participation in the survey data collection process. Data collection staff, blind to school study condition, recruited 7th-grade students attending eligible classes across the 20 middle schools participating in the randomized controlled trial. A mix of census and sampling was used when securing consent for participation. In schools with 250 or fewer 7th-grade students, consents were distributed to all students. For schools with 7th-grade enrollments of more than 250, classes were sampled randomly and consents were distributed to 180 students. The study included one cohort and followed students from 7th through 9th grades. The final enrolled sample size was 2,588 students for whom parental consent and student assent were obtained.
Setting: The study sites included 20 urban middle schools, in Harris County, Texas. The program was implemented in 10 intervention schools by trained facilitators. Most facilitators in both 7th and 8th grades were physical education teachers.
Data Collection: Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.
Data Analysis: Impact data were analyzed using multilevel regression due to the nested nature of the study design (students within schools).
Sample: This sample included students at 20 schools from selected school districts throughout the greater Houston, Texas, area that agreed to participate in the study and that served 7th and 8th grades. Student inclusion criteria required that students not face language barriers or require educational accommodations that would preclude them from participation in the survey data collection process. Data collection staff, blind to school study condition, recruited 7th-grade students attending eligible classes across the 20 middle schools participating in the randomized controlled trial. A mix of census and sampling was used when securing consent for participation. In schools with 250 or fewer 7th-grade students, consents were distributed to all students. For schools with 7th-grade enrollments of more than 250, classes were sampled randomly and consents were distributed to 180 students. The study included one cohort and followed students from 7th through 9th grades. The final enrolled sample size was 2,588 students for whom parental consent and student assent were obtained.
Setting: The study sites included 20 urban middle schools, in Harris County, Texas. The program was implemented in 10 intervention schools by trained facilitators. Most facilitators in both 7th and 8th grades were physical education teachers.
Data Collection: Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.
Data Analysis: Impact data were analyzed using multilevel regression due to the nested nature of the study design (students within schools).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: