Clinical trial NCT03240887: Evaluation of Peer Group Connection
Official title: The Evaluation of Peer Group Connection in Rural North Carolina and New York City, New York
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy in Adolescence
Keywords: Teen pregnancy prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: The Office of Adolescent Health, HHS
name: Mathematica Policy Research, Inc.
First posted: 2017-08-07
Enrollment: 1523
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized controlled trial is being conducted in high schools in North Carolina and New York City to determine the impact of a school-based, positive youth development program on sexual behaviors associated with teen pregnancy

Detailed description: The Policy \& Research Group (PRG) is conducting a rigorous evaluation of the Peer Group Connection (PGC) program's impact on sexual behaviors associated with teen pregnancy. PGC is a school-based, group peer mentoring program for ninth grade students that is designed to facilitate the transition into high school and improve non-cognitive abilities, student engagement, and educational outcomes. The study enrolls students from high schools that serve large populations of economically disadvantaged and minority students in communities with high teenage birth rates. In North Carolina, the study is being implemented in schools serving rural populations, and in New York City, schools serving largely Hispanic and other minority populations are targeted.

As part of the PGC program, ninth-grade participants attend weekly group outreach sessions led by older peer leaders. Outreach sessions occur during regularly scheduled classes (participants are pulled from their classes to attend). They include hands-on activities, simulations, and discussions intended to build group cohesion and to improve the decision-making skills of group members. A minimum of 18, 45-minute outreach sessions are expected to be offered to PGC participants during the course of their ninth-grade year. Although PGC is not explicitly a sexual health or teen pregnancy prevention program, the belief is that by engaging ninth grade students in school, building connectedness among peers, and building students' decision-making and goal-setting skills, PGC will encourage students to make healthier decisions, including reducing sexual risk-taking and increasing protective behaviors.

The comparison condition consists of normally scheduled classes or activities (e.g., Physical Education/Health class, elective class, or homeroom period) that comparison group participants are assigned to during the period that PGC outreaches occur. Comparison group participants will therefore receive more time in the regularly scheduled class than will the treatment group, but there will be no alternative program or additional activities offered to the participants assigned to the comparison group.

The study is an individual randomized controlled trial in which eligible, consenting ninth grade participants are randomly assigned by the evaluator to intervention (PGC) or control (class as usual) groups at a 1:1 ratio. Outcomes will be assessed using questionnaire data gathered at three time points: baseline, occurring during the fall of participants' 9th grade year (prior to the provision of any PGC programming), and follow-up during the fall of their 10th and 11th grade years. Primary outcomes of interest include sexual initiation, frequency of any type of sex, and number of sexual partners.

Eligibility criteria: Inclusion Criteria:

1. Be enrolled at a study school
2. Provide parental consent and personal assent to participate in the study
3. Meet basic requirements for data collection (students must have the ability to complete a self-administered Participant Questionnaire, which is available in English and Spanish, in a classroom or group setting, unassisted, in 60 minutes or less.)
4. Be entering the ninth grade for the first time.

Exclusion Criteria:

1. Be intending to enroll in a non-study school in ninth grade.
2. Be repeating ninth grade.
3. Be unable to complete the questionnaire without assistance.

Primary outcomes:
measure: Sexual initiation
timeFrame: 1 year after baseline, or the beginning of the 10th grade
measure: Frequency of sex
timeFrame: 1 year after baseline, or the beginning of the 10th grade
measure: Number of sexual partners
timeFrame: 1 year after baseline, or the beginning of the 10th grade
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Policy & Research Group
state: Louisiana
Study officials:
affiliation: The Policy & Research Group
name: Eric Jenner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: