NCT05087004

Brief Summary

This is a randomized controlled trial (RCT) evaluation of the Teen Council program that was tested with high school students (grades 10-12) to assess whether it results in a reduction of teen pregnancy among other outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
810

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

5.2 years

First QC Date

September 30, 2021

Last Update Submit

October 18, 2021

Conditions

Keywords

Adolescent pregnancy preventionYouth development

Outcome Measures

Primary Outcomes (8)

  • Ever had sex

    Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.

    Prior to program participation (baseline)

  • Ever had sex

    Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.

    1 year

  • Contraceptive use at last intercourse

    Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.

    Prior to program participation (baseline)

  • Contraceptive use at last intercourse

    Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.

    1 year

  • Changes to contraceptive method in last year

    Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.

    Prior to program participation (baseline)

  • Changes to contraceptive method in last year

    Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.

    1 year

  • Ever visited doctor/clinic for birth control, exam, or STI

    Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.

    Prior to program participation (baseline)

  • Ever visited doctor/clinic for birth control, exam, or STI

    Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.

    1 year

Secondary Outcomes (10)

  • Comfort with own sexuality scale

    Prior to program participation (baseline)

  • Comfort with own sexuality scale

    1 year

  • Confidence in peer education skills scale

    Prior to program participation (baseline)

  • Confidence in peer education skills scale

    1 year

  • Civic action scale

    Prior to program participation (baseline)

  • +5 more secondary outcomes

Study Arms (2)

Teen Council Pogram

EXPERIMENTAL

Teens assigned to the intervention group received a 1-year long Teen Council Program.

Behavioral: Teen Council

Control Group

NO INTERVENTION

Teens assigned to the control group did not receive any intervention.

Interventions

Teen CouncilBEHAVIORAL

Youth randomly selected for Teen Council attended weekly meetings for an entire school year to receive training on specific topics. In turn, they provided educational presentations to the community, which required that they miss school (about one day per month). The presentations Teen Council members offered in middle and high schools were most commonly on birth control methods; relationships; reproductive anatomy and physiology; sexual diversity; STDs/STIs; sexual consent; HIV/AIDS; and abstinence.

Teen Council Pogram

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Applicants had to be:
  • entering 10th, 11th, or 12th grades;
  • able to attend an annual mandatory overnight retreat;
  • interested in providing accurate sexual health information to peers;
  • able to commit to weekly meetings;
  • able to miss school occasionally for presentations (one day per month);
  • responsible for budgeting their time and keeping up with their academic work.

You may not qualify if:

  • was not entering 10th, 11th, or 12th grades;
  • was not able to attend an annual mandatory overnight retreat;
  • was not interested in providing accurate sexual health information to peers;
  • was not able to commit to weekly meetings;
  • was not able to miss school occasionally for presentations (one day per month); (6) was not responsible for budgeting their time and keeping up with their academic work.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participating Planned Parenthood affiliates recruited teens to their Teen Council program each study year during the spring and summer months. Interested teens completed an application and, if after review they were deemed by the program to be good candidates, they were interviewed. Active consent was obtained from the parents or guardians of all eligible youth and teen assent was also collected. Twice as many qualified applicants as spots on each Teen Council were accepted and their names were submitted to Philliber for random assignment to the program or survey-only groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researh Associate

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 21, 2021

Study Start

June 1, 2014

Primary Completion

August 6, 2019

Study Completion

August 6, 2019

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Full study report is available upon request.