Clinical trial NCT03533192: Replication of Evidence-based Programs
Official title: Teenage Pregnancy Prevention: Replication of Evidence-based Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: ETR Associates
name: The Office of Adolescent Health, HHS
First posted: 2018-05-23
Enrollment: 2588
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Exclusion Criteria:

-did not meet inclusion criteria

Primary outcomes:
measure: Initiation of vaginal or oral sex
timeFrame: 12 months after the program ends
Secondary outcomes:
measure: Initiation of vaginal intercourse
timeFrame: 12 months after the program ends
measure: Initiation of oral sex
timeFrame: 12 months after the program ends
measure: Participation in vaginal sex without a condom
timeFrame: past 3 months
measure: Participation in vaginal sex without an effective method of birth control
timeFrame: past 3 months
measure: Use of Condom at last sex
timeFrame: past 3 months
measure: Use of effective method of birth control at last sex
timeFrame: past 3 months
measure: Percent of youth who report having vaginal sex 2 or more times in the past 3 months
timeFrame: past 3 months
measure: Percent of youth who report having oral sex 2 or more times in the past 3 months
timeFrame: past 3 months
measure: Percent of youth who report having vaginal sex with 2 or more partners in the past 3 months
timeFrame: past 3 months
measure: Percent of youth who report having oral sex with 2 or more partners in the past 3 months
timeFrame: past 3 months
measure: Percent of youth who report using drugs or alcohol before vaginal sex at least 1 time in the past 3 months
timeFrame: past 3 months
measure: Percent of youth who report using drugs or alcohol before oral sex at least 1 time in the past 3 months
timeFrame: past 3 months
measure: General condom knowledge
timeFrame: Past year
measure: General HIV/STI knowledge
timeFrame: Past year
measure: Knowledge of signs and symptoms of STIs
timeFrame: Past year
measure: General beliefs about waiting to have sex
timeFrame: Past year
measure: Beliefs about waiting until marriage to have sex
timeFrame: Past year
measure: Reasons to not have sex
timeFrame: Past year
measure: General beliefs about condoms
timeFrame: Past year
measure: Perceived friends beliefs about waiting to have sex
timeFrame: Past year
measure: Perceived norms about sex (I)
timeFrame: Past year
measure: Perceived norms about sex (II)
timeFrame: Past year
measure: Perceived friends sexual behaviors (I)
timeFrame: Past year
measure: Perceived friends sexual behaviors (II)
timeFrame: Past year
measure: Perceived friends' beliefs about condoms
timeFrame: Past year
measure: Perceived self-efficacy to refrain from having sex
timeFrame: Past year
measure: Perceived self-efficacy to negotiate the use of condoms with a partner
timeFrame: Past year
measure: Perceived self-efficacy to obtain and correctly use condoms
timeFrame: Past year
measure: Personal limits regarding sex
timeFrame: Past year
measure: Personal limits regarding condoms
timeFrame: Past year
measure: Communication with parents about sex
timeFrame: Past year
measure: Exposure to risky situations
timeFrame: Past 3 months
measure: Intentions to have sex in the next year
timeFrame: Past year
measure: Intentions to remain abstinent until the end of high school
timeFrame: Past year
measure: Intentions to remain abstinent until marriage
timeFrame: Past year
measure: Intentions to use a condom if have sex in the next year
timeFrame: Past year
measure: Intentions to use effective birth control if have sex in the next year
timeFrame: Past year
measure: Intentions to get tested for HIV/STI if think at risk
timeFrame: Past year
Other outcomes:
Locations:
Study officials:
affiliation: UT School of Public Health
name: Susan T Emery, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.