- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03374696
Theater in School Sex Education - a Randomized Controlled Study
December 14, 2017 updated by: Annsofie Adolfsson, Örebro University, Sweden
Prevention of Chlamydia Infection With Theater in School Sex Education - a Randomized Controlled Study
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
826
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 15 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- students in eighth grade
- could read and understand Swedish
Exclusion Criteria:
- students in special education.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
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.
|
|
ACTIVE_COMPARATOR: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- Knowledge of condom use and chlamydia. - Attitudes toward condom use. - Behavior relating to condom use.
Time Frame: One month.
|
Web-based surveys contained questions about
|
One month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Annsofie Adolfsson, Med Dr, Orebro University, School of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2016
Primary Completion (ACTUAL)
March 31, 2017
Study Completion (ACTUAL)
March 31, 2017
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
December 14, 2017
First Posted (ACTUAL)
December 15, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 15, 2017
Last Update Submitted That Met QC Criteria
December 14, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Orebro U Sex education
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
De-identified individual participant data for all primary outcome measures will be made available on request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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