AttitudeNCT03374696
Theater in School Sex Education - a Randomized Controlled Study
A study testing SAFETY and Standard education in people with Attitude and Sexual Behavior, run by Örebro University, Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Attitude, Sexual Behavior, Condom Use
- What is being tested?
- SAFETY and Standard education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 826 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 31 Mar 2017
- 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 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students in eighth grade
- could read and understand Swedish
Who cannot join
- students in special education.
About this study
Official title: 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.
Read the 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.
- Conditions
- Attitude, Sexual Behavior, Condom Use, Prevention, Chlamydia Infections, Safe Sex
- Being tested
- SAFETY, Standard education
- Keywords
- Chlamydia infections, condoms, theater,, sex education
- Medical subject headings
- Behavior, Sexual Behavior, Chlamydia Infections, Safe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFETYBehavioural
Standard educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: SAFETY |
| Control group | Active comparator | 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. Receives: Behavioral: Standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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)
Measured: One month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Dec 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized controlled trial with parallel assignment
- Masking
- None (open label)
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annsofie Adolfsson, Örebro University, Sweden
- Investigators
- Annsofie Adolfsson, Med Dr, Principal investigator, Orebro University, School of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374696
- Sponsor's protocol ID
- Orebro U Sex education
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data for all primary outcome measures will be made available on request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Chlamydia Infection With Theater in School Sex Education - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03374696
- Acronym / sponsor ID
- Orebro U Sex education
- Conditions
- Attitude, Sexual Behavior, Condom Use, Prevention, Chlamydia Infections, Safe Sex
- Keywords
- Chlamydia infections, condoms, theater,, sex education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial with parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: SAFETYThe 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. |
| Control group | Active comparator | Behavioral: Standard educationThe 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. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- students in eighth grade
- could read and understand Swedish
Key exclusion criteria (1 listed)
- students in special education.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAFETY | Behavioural | Intervention group |
| Standard education | Behavioural | Control group |
Primary outcome
- 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 * knowledge of condom use and chlamydia (7 questions) * attitudes toward condom use (5 questions) * behavior relating to condom use (6 questions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Individual participant dataSharing planned: No. De-identified individual participant data for all primary outcome measures will be made available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annsofie Adolfsson, Med Dr principal investigator
Orebro University, School of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing SAFETY and Standard education in people with Attitude and Sexual Behavior, run by Örebro University, Sweden.
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 2 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 15 Dec 2017. 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?
- Knowledge of condom use and chlamydia. - Attitudes toward condom use. - Behavior relating to condom use. (time frame: One month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2017.