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Teen PregnancyN2KNCT02539602

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

A study testing The Need to Know students received the N2K curriculum as described previously in people with Teen Pregnancy, run by The University of Texas Health Science Center at San Antonio.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Teen Pregnancy
What is being tested?
The Need to Know students received the N2K curriculum as described previously
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,616 participants
Where
No sites listed yet
Study dates
Sep 2011to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Rigorous Evaluation of Need to Know (N2K): A Three-Year Quasi-Experimental Sex Education Program for High School Students in Texas

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.

Read the detailed description

Need to Know is based on a framework of positive youth development intended to delay sexual initiation and reduce the rate of teenage pregnancy. The N2K curriculum is designed to support the treatment participants throughout their high school career with consecutive dosage for three years from 9th through 11th grade. 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 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.

The 9th grade course is N2K: Basics and consists of lessons that encourage self-discovery and goal setting, discuss human growth and development, adolescent risk behaviors, communication, STDs, abstinence, contraceptives, teen dating violence, legal issues, responsible media use, refusal skills, and role-playing. The 10th grade N2K: Decisions consists of lessons that increase decision making skills, clarify values, promote healthy relationships and the benefits of delaying sex, and review of anatomy, contraceptives, STDs, and legal issues. It promotes the development of critical thinking skills and application of the facts to real life situations. N2K: Decisions includes an original webisode series of 11 episodes, the first of which is viewed in class, and the others can be viewed online outside of class. The webisode series adds narrative to the basic facts being presented in class. The series runs, in conjunction with the 10th grade curriculum lessons 3-8. The 11th grade N2K: Relationships reinforces basic themes taught in prior years. It emphasizes healthy relationships, healthy living, and taking responsibility for personal health as an adolescent matures into adult life. The last three lessons are a culminating activity that allows participants to express what they have learned and present it to others. About 35% of the 48 sessions focuses on abstinence, 27% highlight positive youth development (PYD), 13% discuss risky behaviors, 12% address STDs, 8% cover contraceptives, and 5% discuss anatomy and puberty in the cumulative three years of the N2K Curriculum.

A paper and pencil survey was administered in school to assess program impacts. Treatment and comparison students were surveyed at baseline (fall 2011 for comparison and fall 2012 for treatment), and for the treatment group, surveying took place before the intervention began. Surveys were administered at the end of each year of programming (end of 9th grade, end of 10th grade, and end of 11th grade), which for the treatment students was after the N2K programming was completed for the year.

Conditions
Teen Pregnancy
Being tested
The Need to Know students received the N2K curriculum as described previously
Keywords
High school, Longitudnal, Sexual initiation, Contraception, Adolescents, Pregnancy prevention, Sexual health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Need to Know students received the N2K curriculum as described previouslyBehavioural

Study groups in NCT02539602
Study groupRoleWhat they receive
Need to Know (N2K)ExperimentalThe 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.
Receives: Behavioral: The Need to Know students received the N2K curriculum as described previously
CounterfactualNo interventionThe counterfactual condition received no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 years

  2. 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®)

    Measured: 3 years

Secondary outcomes (4)

  1. Delay sexual initiation - Survey question

    1. After one year, 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

    Measured: 1 year

  2. Decreases condom or contraception non-use - Survey question

    1. After one year, 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®)

    Measured: 1 year

  3. Delay sexual initiation - Survey question

    1. After two years, 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

    Measured: 2 years

  4. Decreases condom or contraception non-use - Survey question

    After two years, 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®)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2015 (estimated)
  2. Study startSep 2011
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,616 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539602
Sponsor's protocol ID
HSC20040080E
Acronym
N2K
Status last verified
Aug 2015
First submitted
27 Aug 2015
Last updated
3 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing The Need to Know students received the N2K curriculum as described previously in people with Teen Pregnancy, run by The University of Texas Health Science Center at San Antonio.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delay sexual initiation - Survey question (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2015.

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