Replication of Evidence-based Programs

NCT ID: NCT03533192

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2588 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-07-31

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).

Conditions

Sexual Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Receipt of It's Your Game...Keep it Real

It's Your Game...Keep it Real is an HIV, STI, and teen pregnancy prevention program

Group Type: EXPERIMENTAL

It's Your Game...Keep it Real

Intervention Type: BEHAVIORAL

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.

Usual care

Students received their regular health education.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• enrolled in 7th grade at a participating school in fall 2012
• did not have limited capabilities or special needs as determined by the school
• spoke English well enough to understand the survey questions if they were read aloud.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ETR Associates

OTHER

Sponsor Role: collaborator

The Office of Adolescent Health, HHS

FED

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Melissa Peskin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan T Emery, PhD

Role: PRINCIPAL_INVESTIGATOR

UT School of Public Health

References

Peskin MF, Coyle KK, Anderson PM, Laris BA, Glassman JR, Franks HM, Thiel MA, Potter SC, Unti T, Edwards S, Johnson-Baker K, Cuccaro PM, Diamond P, Markham CM, Shegog R, Baumler ER, Gabay EK, Emery ST. Replication of It's Your Game...Keep It Real! in Southeast Texas. J Prim Prev. 2019 Jun;40(3):297-323. doi: 10.1007/s10935-019-00549-0.

Reference Type: DERIVED

PMID: 31028508 (View on PubMed)

Other Identifiers

HSC-SPH-10-0455

Identifier Type: -

Identifier Source: org_study_id