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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Stop sexual harassment
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.

Norway1 site
  • NORCE Norwegian Research Centre

    Bergen, 5838

Other trials in Norway

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.

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 groups in NCT04716400
Study groupRoleWhat they receive
Intervention groupExperimental"Stop sexual harassment"
Receives: Behavioral: Stop sexual harassment
Control groupNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline sexual harassment

    Experiences of sexual harassment in schools (AAUW, 2001; 2011)

    Measured: Two months

  2. Change from baseline sexual harassment at eight months

    Experiences of sexual harassment in schools (AAUW, 2001; 2011)

    Measured: Two months

  3. Change from baseline sexual harassment at one year

    Experiences of sexual harassment in schools (AAUW, 2001; 2011)

    Measured: Two months

  4. 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

  5. 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

  6. 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)
  1. 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

  2. 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

  3. 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

  4. Baseline externalized problems

    Bullying (Olweus \& Endresen, 1998) and The Bergen Questionnaire on Antisocial Behaviour (Bendixen \& Olweus, 1999; Bendixen, Endresen \& Olweus, 2003)

    Measured: Two months

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted20 Jan 2021
  2. Study start13 Apr 2021
  3. Primary completion30 May 2022
  4. Study completion30 Jun 2023

Resources

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)
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

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.

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