NCT03374696

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
826

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 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

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

December 11, 2017

Last Update Submit

December 14, 2017

Conditions

Keywords

Chlamydia infectionscondomstheater,sex education

Outcome Measures

Primary Outcomes (1)

  • - 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)

    One month.

Study Arms (2)

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.

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.

Behavioral: Standard education

Interventions

SAFETYBEHAVIORAL
Intervention group
Control group

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • students in eighth grade
  • could read and understand Swedish

You may not qualify if:

  • students in special education.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BehaviorSexual BehaviorChlamydia InfectionsSafe Sex

Interventions

Safety

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Annsofie Adolfsson, Med Dr

    Orebro University, School of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-randomized controlled trial with parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 15, 2017

Study Start

December 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

December 15, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data for all primary outcome measures will be made available on request.