Replication of Evidence-based Programs

NCT03533192 | Completed

• 1 other identifier: HSC-SPH-10-0455
• Study Type: interventional
• Target: 2,588
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sexual Behavior

Outcome Measures

Primary Outcomes (1)

• Initiation of vaginal or oral sex

  The variable is a yes/no measure of whether a person has ever had vaginal OR oral sex. The measure is created from the following items on the survey: * "Have you ever had sexual intercourse?" (defined in survey as penis in vagina) * "Have you ever had oral sex?" Participants who respond yes they have had sexual intercourse OR yes they have had oral sex are coded as 1 for yes; those who respond no they have not had sexual intercourse AND no they have not had oral sex are coded as 0 for no.

  12 months after the program ends

Secondary Outcomes (38)

• Initiation of vaginal intercourse

  12 months after the program ends

• Initiation of oral sex

  12 months after the program ends

• Participation in vaginal sex without a condom

  past 3 months

• Participation in vaginal sex without an effective method of birth control

  past 3 months

• Use of Condom at last sex

  past 3 months

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: It's Your Game...Keep it Real

Usual care

NO INTERVENTION

Students received their regular health education.

Interventions

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

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

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• ETR Associates: collaborator
• The Office of Adolescent Health, HHS: collaborator

Related Publications (1)

• 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.

  PMID: 31028508 DERIVED

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Susan T Emery, PhD

  UT School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors were blind to condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 23, 2018
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share