Sexual HarassmentNCT04716400
Effectiveness Study of the Intervention "Stop Sexual Harassment" in Secondary School
A study testing Stop sexual harassment in people with Sexual Harassment and Anti-Gay Bias, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial summary
"Stop sexual harassment" is a school based intervention tailored to reduce sexual- and gendered harassment among pupils in secondary school. The first aim of this study is to test to what extent "Stop sexual harassment" reduces sexual harassment and harassment based on sexual orientation and gender expression… Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Harassment, Anti-Gay Bias, Non Sexual Harassment
- What is being tested?
- Stop sexual harassment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,037 participants
- Where
- 1 siteNorway
- Study dates
- 13 Apr 2021to 30 Jun 2023
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pupils belonging to classes where their main teacher has agreed to participate in the intervention
Who cannot join
- Is not able to read and write a minimum level of Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Controlled Trial of the Intervention "Stop Sexual Harassment" in Norwegian Secondary Schools
"Stop sexual harassment" is a school based intervention tailored to reduce sexual- and gendered harassment among pupils in secondary school. The first aim of this study is to test to what extent "Stop sexual harassment" reduces sexual harassment and harassment based on sexual orientation and gender expression (gendered harassment) among 8th to 10th grade pupils in secondary school. The second aim of the study is to test to what extent the intervention increases teachers' responses to sexual- and gendered harassment among pupils. The intervention consists of eight lessons which address the prevention of sexual- and gendered harassment.
METHOD: A minimum 32 schools with at least 3840 pupils will participate in a cluster randomized controlled trial. Participating schools will be randomly assigned to intervention schools and control schools. At the intervention schools, teachers will be introduced to "Stop sexual harassment" through a digital course which will provide them with a manual containing eight lessons to be held for the pupils. At the control schools there will not be any intervention. The effects of the intervention on pupils will be determined by assessing their experiences with sexual and gendered harassment, and internalized and externalized problems prior to the intervention (T1), shortly after the intervention (T2) and six moths after the intervention (T3). The effects of the intervention on teachers will be determined by assessing the teachers' experiences of responding to sexual and gendered harassment among pupils.
HYPOTHESIS: It is expected that the intervention "Stop sexual harassment" will lead to reduced sexual and gendered harassment perpetration and victimization, and less internalized and externalized problems among the pupils in secondary school, and that teachers will more frequently take action when sexual- and gendered harassment is encountered among the pupils.
Read the detailed description
AIMS AND HYPOTHESIS The first aim of this study is to test the effects of "Stop sexual harassment", a sexual- and gendered harassment prevention intervention in secondary school among 8th to 10th grade pupils. The second aim of the study is to test the effects of the intervention on teachers' responses to sexual- and gendered harassment among the pupils. "Stop sexual harassment" is targeted at both pupils and teachers with the intention of reducing sexual harassment and harassment based on sexual orientation and gender expression (gendered harassment) among the pupils. It is hypothesized that the intervention will lead to reduced sexual- and gendered harassment perpetration and victimization and less internalized and externalized problems among the pupils. It is also hypothesized that the intervention will lead to teachers more frequently taking action when sexual- and gendered harassment is encountered among pupils.
DESIGN AND METHOD Recruitment: All secondary schools (8th to 10th grade) in three counties (Vestland, Nordland and former county Buskerud) in Norway will be invited to take part in the intervention.
Design: A cluster randomized controlled trial will be used to test the effects of the intervention. Participating schools will be randomly assigned to intervention schools and control schools.
Assessment: Questionnaires will be administered to pupils and teachers, prior to the intervention to obtain a baseline level (T1), shortly after the intervention (T2), and about six months after the intervention (T3). Previously tested instruments to assess to what extent the intervention leads to reduction in sexual harassment and harassment based on sexual orientation and gender expression among the pupils will be utilized. Teachers' responses to the pupils' sexual and gendered harassment will also be assessed.
Data analytic plan and power analysis: The data will be analyzed with both simple descriptive (such as correlations, frequency tables) and advanced statistical methods. With regard to the latter, 3 level multilevel modelling will be used to assess the impact of the intervention on the outcome variables. Multilevel modelling takes into account the hierarchical design of the data due to cluster randomization by school (level 3) and school class (level 2). Cluster effects were approximated (Intra Class Correlation; ICC) influencing the main outcomes (Sexual harassment, emotional problems, attitudes towards homosexuals) by taking advantage of data from previous studies. These studies indicate that whereas relatively little (often less than 5%) of the total variance of sexual harassment victimization, bullying and emotional problems are at the school and/or school class level, a still limited amount of studies suggests that this might not be the case for instance attitudes towards homosexuals where as much as 12,5 - 30% of the total variance have been explained by school/class levels. Power calculations, by the use the Optimal Design Software, showed that with a .05 level of significance, power = .80, ICC level 2 = .25, ICC level 3=0.05, number of cluster level 2=6 (classes) with a cluster size=20 (pupils), 38 schools are needed to be able to detect effect sizes of .30 (about medium effects according to Cohen (1988). The power of the analyses can be increased by including the pre-intervention measure of the outcome variable. Assuming the average school level of the outcome variable at pre-intervention explains 50 or 30 percent of the variation of the outcome variable at post-test, decreases the number of schools to 30 and 32, respectively, given the same assumptions as above. It was therefore decided to include at least 32 schools (16 intervention schools) to guard against the possibility of type II errors. A minimum of 3840 pupils will thus take part in the study.
- Conditions
- Sexual Harassment, Anti-Gay Bias, Non Sexual Harassment, Gender-based Violence, Gender Bias, Bullying
- Being tested
- Stop sexual harassment
- Keywords
- Sexual harassment, Gendered harassment, Homophobic harassment, Intervention program, RCT study, Secondary school, Youth, Teachers, Pupils, LGBTQ
- Medical subject headings
- Sexual Harassment, Homophobia, Harassment, Non-Sexual, Sexism, Bullying, Aggression, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop sexual harassmentBehavioural
Teachers will be introduced to a digital course on the prevention of sexual- and gendered harassment. In the course they will provided with a manual containing eight lessons to be held for the pupils. Each lesson will last 45 minutes and consist of a short lecture and practical activities for the pupils.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | "Stop sexual harassment" Receives: Behavioral: Stop sexual harassment |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline sexual harassment
Experiences of sexual harassment in schools (AAUW, 2001; 2011)
Measured: Two months
Change from baseline sexual harassment at eight months
Experiences of sexual harassment in schools (AAUW, 2001; 2011)
Measured: Two months
Change from baseline sexual harassment at one year
Experiences of sexual harassment in schools (AAUW, 2001; 2011)
Measured: Two months
Baseline gendered harassment
Experiences of homophobic harassment, and harassment due to sexual orientation and gender non-conformity (Martin-Storey \& August, 2016; Poteat, 2014)
Measured: Two months
Change from baseline gendered harassment at eight months
Experiences of homophobic harassment, and harassment due to sexual orientation and gender non-conformity (Martin-Storey \& August, 2016; Poteat, 2014)
Measured: Two months
Change from baseline gendered harassment at one year
Experiences of homophobic harassment, and harassment due to sexual orientation and gender non-conformity (Martin-Storey \& August, 2016; Poteat, 2014)
Measured: Two months
Secondary outcomes (9)
Baseline internalized problems
Moods and Feelings Questionnaire (Angold, 1995; Larson, Ingul, Jozefiak, Leikanger \& Sund, 2016; Lundervold, Brevik, Possserud, Stormark \& Hysing, 2013). Screen for Child Anxiety Related Disorders (Birmaher, Khetarpal, Cully, Brent \&McKenzie, 1996)
Measured: Two months
Change from internalized problems at eight months
Moods and Feelings Questionnaire (Angold, 1995; Larson, Ingul, Jozefiak, Leikanger \& Sund, 2016; Lundervold, Brevik, Possserud, Stormark \& Hysing, 2013). Screen for Child Anxiety Related Disorders (Birmaher, Khetarpal, Cully, Brent \&McKenzie, 1996)
Measured: Two months
Change from baseline internalized problems at one year
Moods and Feelings Questionnaire (Angold, 1995; Larson, Ingul, Jozefiak, Leikanger \& Sund, 2016; Lundervold, Brevik, Possserud, Stormark \& Hysing, 2013). Screen for Child Anxiety Related Disorders (Birmaher, Khetarpal, Cully, Brent \&McKenzie, 1996)
Measured: Two months
Baseline externalized problems
Bullying (Olweus \& Endresen, 1998) and The Bergen Questionnaire on Antisocial Behaviour (Bendixen \& Olweus, 1999; Bendixen, Endresen \& Olweus, 2003)
Measured: Two months
Change from externalized problems at eight months
Bullying (Olweus \& Endresen, 1998) and The Bergen Questionnaire on Antisocial Behaviour (Bendixen \& Olweus, 1999; Bendixen, Endresen \& Olweus, 2003)
Measured: Two months
Change from externalized problems at one year
Bullying (Olweus \& Endresen, 1998) and The Bergen Questionnaire on Antisocial Behaviour (Bendixen \& Olweus, 1999; Bendixen, Endresen \& Olweus, 2003)
Measured: Two months
Baseline teachers' reactions to sexual and gendered harassment (Teacher questionnaire)
Modified versions of the primary outcome measures, including teachers' action, intentions to act and attitudes towards sexual and gendered harassment
Measured: Two months
Change from teachers' reactions to sexual and gendered harassment at eight months (Teacher questionnaire)
Modified versions of the primary outcome measures, including teachers' action, intentions to act and attitudes towards sexual and gendered harassment
Measured: Two months
Change from teachers' reactions to sexual and gendered harassment at one year (Teacher questionnaire)
Modified versions of the primary outcome measures, including teachers' action, intentions to act and attitudes towards sexual and gendered harassment
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start13 Apr 2021
- Primary completion30 May 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual HarassmentStudies 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 study. The randomization is at school level.
- Masking
- None (open label)
- Enrolment
- 2,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Boston College, Norwegian Council for Mental Health, The Dam Foundation
- Responsible party
- Principal investigator, Hilde Slåtten, NORCE Norwegian Research Centre AS
- Investigators
- Hilde Slaatten, Ph.D, Principal investigator, NORCE Norwegian Research Centre AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716400
- Sponsor's protocol ID
- NORCE
- Other IDs
- Funder
- Status last verified
- Nov 2023
- First submitted
- 13 Jan 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slaatten H, Haugland BSM, Bjorknes R, Fyhn T, Tveito TH, Poteat VP, Breivik K. Stop Sexual Harassment: A study protocol for a cluster randomised controlled trial in secondary schools in Norway. Front Public Health. 2023 Jan 9;10:1051983. doi: 10.3389/fpubh.2022.1051983. eCollection 2022.
PubMed 36699896
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial of the Intervention "Stop Sexual Harassment" in Norwegian Secondary Schools
- ClinicalTrials.gov ID
- NCT04716400
- Acronym / sponsor ID
- NORCE
- Conditions
- Sexual Harassment, Anti-Gay Bias, Non Sexual Harassment, Gender-based Violence, Gender Bias, Bullying
- Keywords
- Sexual harassment, Gendered harassment, Homophobic harassment, Intervention program, RCT study, Secondary school, Youth, Teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,037 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- University of Bergen, Boston College, Norwegian Council for Mental Health, The Dam Foundation
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Jan 2021 (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.
"Stop sexual harassment" is a school based intervention tailored to reduce sexual- and gendered harassment among pupils in secondary school. The first aim of this study is to test to what extent "Stop sexual harassment" reduces sexual harassment and harassment based on sexual orientation and gender expression (gendered harassment) among 8th to 10th grade pupils in secondary school. The second aim of the study is to test to what extent the intervention increases teachers' responses to sexual- and gendered harassment among pupils. The intervention consists of eight lessons which address the prevention of sexual- and gendered harassment.
METHOD: A minimum 32 schools with at least 3840 pupils will participate in a cluster randomized controlled trial. Participating schools will be randomly assigned to intervention schools and control schools. At the intervention schools, teachers will be introduced to "Stop sexual harassment" through a digital course which will provide them with a manual containing eight lessons to be held for the pupils. At the control schools there will not be any intervention. The effects of the intervention on pupils will be determined by assessing their experiences with sexual and gendered harassment, and internalized and externalized problems prior to the intervention (T1), shortly after the intervention (T2) and six moths after the intervention (T3). The effects of the intervention on teachers will be determined by assessing the teachers' experiences of responding to sexual and gendered harassment among pupils.
HYPOTHESIS: It is expected that the intervention "Stop sexual harassment" will lead to reduced sexual and gendered harassment perpetration and victimization, and less internalized and externalized problems among the pupils in secondary school, and that teachers will more frequently take action when sexual- and gendered harassment is encountered among the pupils.
Detailed description
AIMS AND HYPOTHESIS The first aim of this study is to test the effects of "Stop sexual harassment", a sexual- and gendered harassment prevention intervention in secondary school among 8th to 10th grade pupils. The second aim of the study is to test the effects of the intervention on teachers' responses to sexual- and gendered harassment among the pupils. "Stop sexual harassment" is targeted at both pupils and teachers with the intention of reducing sexual harassment and harassment based on sexual orientation and gender expression (gendered harassment) among the pupils. It is hypothesized that the intervention will lead to reduced sexual- and gendered harassment perpetration and victimization and less internalized and externalized problems among the pupils. It is also hypothesized that the intervention will lead to teachers more frequently taking action when sexual- and gendered harassment is encountered among pupils.
DESIGN AND METHOD Recruitment: All secondary schools (8th to 10th grade) in three counties (Vestland, Nordland and former county Buskerud) in Norway will be invited to take part in the intervention.
Design: A cluster randomized controlled trial will be used to test the effects of the intervention. Participating schools will be randomly assigned to intervention schools and control schools.
Assessment: Questionnaires will be administered to pupils and teachers, prior to the intervention to obtain a baseline level (T1), shortly after the intervention (T2), and about six months after the intervention (T3). Previously tested instruments to assess to what extent the intervention leads to reduction in sexual harassment and harassment based on sexual orientation and gender expression among the pupils will be utilized. Teachers' responses to the pupils' sexual and gendered harassment will also be assessed.
Data analytic plan and power analysis: The data will be analyzed with both simple descriptive (such as correlations, frequency tables) and advanced statistical methods. With regard to the latter, 3 level multilevel modelling will be used to assess the impact of the intervention on the outcome variables. Multilevel modelling takes into account the hierarchical design of the data due to cluster randomization by school (level 3) and school class (level 2). Cluster effects were approximated (Intra Class Correlation; ICC) influencing the main outcomes (Sexual harassment, emotional problems, attitudes towards homosexuals) by taking advantage of data from previous studies. These studies indicate that whereas relatively little (often less than 5%) of the total variance of sexual harassment victimization, bullying and emotional problems are at the school and/or school class level, a still limited amount of studies suggests that this might not be the case for instance attitudes towards homosexuals where as much as 12,5 - 30% of the total variance have been explained by school/class levels. Power calculations, by the use the Optimal Design Software, showed that with a .05 level of significance, power = .80, ICC level 2 = .25, ICC level 3=0.05, number of cluster level 2=6 (classes) with a cluster size=20 (pupils), 38 schools are needed to be able to detect effect sizes of .30 (about medium effects according to Cohen (1988). The power of the analyses can be increased by including the pre-intervention measure of the outcome variable. Assuming the average school level of the outcome variable at pre-intervention explains 50 or 30 percent of the variation of the outcome variable at post-test, decreases the number of schools to 30 and 32, respectively, given the same assumptions as above. It was therefore decided to include at least 32 schools (16 intervention schools) to guard against the possibility of type II errors. A minimum of 3840 pupils will thus take part in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled study. The randomization is at school level.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Stop sexual harassment"Stop sexual harassment" |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pupils belonging to classes where their main teacher has agreed to participate in the intervention
Key exclusion criteria (1 listed)
- Is not able to read and write a minimum level of Norwegian
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 |
|---|---|---|
| Stop sexual harassmentTeachers will be introduced to a digital course on the prevention of sexual- and gendered harassment. In the course they will provided with a manual containing eight lessons to be held for the pupils. Each lesson will last 45 minutes and consist of a short lecture and practical activities for the pupils. | Behavioural | Intervention group |
Primary outcome
Baseline sexual harassment
Time frame: Two months
Experiences of sexual harassment in schools (AAUW, 2001; 2011)
Change from baseline sexual harassment at eight months
Time frame: Two months
Experiences of sexual harassment in schools (AAUW, 2001; 2011)
Change from baseline sexual harassment at one year
Time frame: Two months
Experiences of sexual harassment in schools (AAUW, 2001; 2011)
Baseline gendered harassment
Time frame: Two months
Experiences of homophobic harassment, and harassment due to sexual orientation and gender non-conformity (Martin-Storey \& August, 2016; Poteat, 2014)
Change from baseline gendered harassment at eight months
Time frame: Two months
Experiences of homophobic harassment, and harassment due to sexual orientation and gender non-conformity (Martin-Storey \& August, 2016; Poteat, 2014)
Change from baseline gendered harassment at one year
Time frame: Two months
Experiences of homophobic harassment, and harassment due to sexual orientation and gender non-conformity (Martin-Storey \& August, 2016; Poteat, 2014)
9 secondary outcomes
Baseline internalized problems
Time frame: Two months
Change from internalized problems at eight months
Time frame: Two months
Change from baseline internalized problems at one year
Time frame: Two months
Baseline externalized problems
Time frame: Two months
Change from externalized problems at eight months
Time frame: Two months
Change from externalized problems at one year
Time frame: Two months
Baseline teachers' reactions to sexual and gendered harassment (Teacher questionnaire)
Time frame: Two months
Change from teachers' reactions to sexual and gendered harassment at eight months (Teacher questionnaire)
Time frame: Two months
Change from teachers' reactions to sexual and gendered harassment at one year (Teacher questionnaire)
Time frame: Two months
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 27 Nov 2023.
- Derived from this study: PubMed 36699896Slaatten H, Haugland BSM, Bjorknes R, Fyhn T, Tveito TH, Poteat VP, Breivik K. Stop Sexual Harassment: A study protocol for a cluster randomised controlled trial in secondary schools in Norway. Front Public Health. 2023 Jan 9;10:1051983. doi: 10.3389/fpubh.2022.1051983. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Hilde Slaatten, Ph.D principal investigator
NORCE Norwegian Research Centre AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stop sexual harassment in people with Sexual Harassment and Anti-Gay Bias, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
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 1 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Baseline sexual harassment (time frame: Two months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04716400, which also lists 1 linked publication.
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 27 Nov 2023.