Evaluation of a Need to Know (N2K): A New Sex Education Program for High School Students

NCT02539602 | Completed

• 1 other identifier: HSC20040080E
• Study Type: interventional
• Target: 1,616
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial evaluated the impact of N2K, a three-year quasi-experimental study to delay sexual initiation and increase condom and contraception use among high school students. The program was administered to treatment students beginning in the fall of 2012 (9th grade) and continued through the spring of 2015 (11th grade). The purpose of this study was to measure: 1) the impact of N2K on sexual initiation at the end of the three-year program and 2) the impact of N2K on condom or contraception non-use at the end of the program.

Conditions

Teen Pregnancy

Keywords

High school; Longitudnal; Sexual initiation; Contraception; Adolescents; Pregnancy prevention; Sexual health

Outcome Measures

Primary Outcomes (2)

• Delay sexual initiation - Survey question

  At program completion, what is the impact of Need to Know (N2K), a three-year program, on sexual initiation (vaginal intercourse) among virgins at baseline? Sexual initiation was measured by a survey question asking: Have you ever had sexual intercourse? Yes or No

  3 years

• Decreases condom or contraception non-use - Survey question

  At program completion, what is the impact of Need to Know (N2K), a three-year program, on condom or contraception non-use for the full analytic sample? Condom or contraception non-use was measured by asking the following two survey questions: A: In the past 3 months, have you had sexual intercourse without you or your partner using a condom, even once? Yes or No B: In the past 3 months, have you had sexual intercourse without using an effective method of birth control, even once? Yes or No * Condoms * Birth control pills * The shot (Depo Provera®) * The patch * The ring (NuvaRing®) * IUD (Mirena or Paragard® or Skyla®) * Implant (Implanon® or Nexplanon®)

  3 years

Secondary Outcomes (4)

• Delay sexual initiation - Survey question

  1 year

• Decreases condom or contraception non-use - Survey question

  1 year

• Delay sexual initiation - Survey question

  2 years

• Decreases condom or contraception non-use - Survey question

  2 years

Study Arms (2)

Need to Know (N2K)

EXPERIMENTAL

The intended dosage for treatment participants is 16 lessons (25 minutes each) each year of the program (8 in the fall and 8 in the spring). The program consists of 3 years (48 lessons) of curriculum intended for 9th, 10th and 11th grade students to be delivered in a group or classroom setting of up to 32 students. There are 16 lessons in each year of the curriculum. Eight lessons are intended to be taught in the fall semester and eight in the spring. Each lesson is 25 minutes long, and can be taught in any class period that allows for 25 minutes of content instruction.

Behavioral: The Need to Know students received the N2K curriculum as described previously

Counterfactual

NO INTERVENTION

The counterfactual condition received no intervention.

Interventions

The Need to Know students received the N2K curriculum as described previously BEHAVIORAL

Need to Know (N2K)

Eligibility Criteria

• Age: 14 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Students were eligible if they were in the 9th grade in the fall of the enrollment year (2011 for comparison students, and 2012 for treatment students), and not enrolled in the LifeSkills Class, which includes students that are severely developmentally challenged. Recruits were both male and female.

You may not qualify if:

• Students were not eligible if they were members of the LifeSkills self-contained special education group and not mainstreamed with other students. Students in the 10th grade who were repeating a 9th grade credit(s) were excluded from Treatment survey analysis.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• The Office of Adolescent Health, HHS: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 3, 2015
• Study Start: September 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 3, 2015

Record last verified: 2015-08