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Theater in School Sex Education - a Randomized Controlled Study

Primary Purpose

Attitude, Sexual Behavior, Condom Use

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SAFETY
Standard education
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Attitude focused on measuring Chlamydia infections, condoms, theater,, sex education

Eligibility Criteria

13 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • students in eighth grade
  • could read and understand Swedish

Exclusion Criteria:

  • students in special education.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    Control group

    Arm Description

    The intervention SAFETY was performed in school facilities by professional actors and staff from the municipality's youth guidance center within the county. The actors first enacted a play portraying youths and problems with condom use. Next, a value exercise was held by the youth guidance center staff. The class continued with chlamydia games held by the youth guidance center staff, providing information on symptoms, protection, how to get tested, treatment and consequences. The youth guidance center staff and the actors, playing students, then held a condom school. Lastly, the students came up with new endings to the play. All replays were enacted and the students gave feedback on the new endings. The class ended with condoms being handed out.

    The intervention in the control group contained standard education from school staff, based on the sex education guidelines of the Swedish National Agency for Education. Students got education on human sexuality, reproduction, menstruation, love, sex, pregnancy and how STIs and unwanted pregnancy are prevented.

    Outcomes

    Primary Outcome Measures

    - Knowledge of condom use and chlamydia. - Attitudes toward condom use. - Behavior relating to condom use.
    Web-based surveys contained questions about knowledge of condom use and chlamydia (7 questions) attitudes toward condom use (5 questions) behavior relating to condom use (6 questions)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2017
    Last Updated
    December 14, 2017
    Sponsor
    Örebro University, Sweden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03374696
    Brief Title
    Theater in School Sex Education - a Randomized Controlled Study
    Official Title
    Prevention of Chlamydia Infection With Theater in School Sex Education - a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    March 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Örebro University, Sweden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study evaluated if interactive theater in school sex education affects student knowledge, attitudes and behavior regarding condom use. The intervention group got a play, value exercises, chlamydia games, condom school and interactive replay with professional actors and staff from a youth guidance center. The control group got standard sex education from school staff, based on the education guidelines of the Swedish National Agency for Education.
    Detailed Description
    The spread of chlamydia indicates that current preventive work with condoms is insufficient. Research shows that reasons behind increased chlamydia include youths taking more sexual risks, due to altered attitudes and sexual behaviors. Since only condoms protect against both sexually transmitted infections (STIs) and unwanted pregnancy, the goal of the World Health Organization (WHO) chlamydia prevention program is to increase condom use. Research suggests that school is the most important arena for sex education, reaching all youths early in life, when many values on sex and relationships are instilled. International studies on theater in sex education indicate effects like increased knowledge on the topic, and partially changed attitudes and behaviors among youths. Furthermore, several studies show that youths feel theater is a good method for sex education and a supplement to standard education.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attitude, Sexual Behavior, Condom Use, Prevention, Chlamydia Infections, Safe Sex
    Keywords
    Chlamydia infections, condoms, theater,, sex education

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster-randomized controlled trial with parallel assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    826 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    The intervention SAFETY was performed in school facilities by professional actors and staff from the municipality's youth guidance center within the county. The actors first enacted a play portraying youths and problems with condom use. Next, a value exercise was held by the youth guidance center staff. The class continued with chlamydia games held by the youth guidance center staff, providing information on symptoms, protection, how to get tested, treatment and consequences. The youth guidance center staff and the actors, playing students, then held a condom school. Lastly, the students came up with new endings to the play. All replays were enacted and the students gave feedback on the new endings. The class ended with condoms being handed out.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The intervention in the control group contained standard education from school staff, based on the sex education guidelines of the Swedish National Agency for Education. Students got education on human sexuality, reproduction, menstruation, love, sex, pregnancy and how STIs and unwanted pregnancy are prevented.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SAFETY
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard education
    Primary Outcome Measure Information:
    Title
    - Knowledge of condom use and chlamydia. - Attitudes toward condom use. - Behavior relating to condom use.
    Description
    Web-based surveys contained questions about knowledge of condom use and chlamydia (7 questions) attitudes toward condom use (5 questions) behavior relating to condom use (6 questions)
    Time Frame
    One month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: students in eighth grade could read and understand Swedish Exclusion Criteria: students in special education.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Annsofie Adolfsson, Med Dr
    Organizational Affiliation
    Orebro University, School of Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    De-identified individual participant data for all primary outcome measures will be made available on request.

    Learn more about this trial

    Theater in School Sex Education - a Randomized Controlled Study

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