Violence Prevention Intervention Evaluation Among YouthNCT06132074
Adolescent Consent & Sexual Violence: A School Intervention Evaluation
A study testing School sessions on consent, reciprocity and sexual violence in people with Violence Prevention Intervention Evaluation Among Youth, run by Uppsala University at 1 site in Sweden.
Trial summary
Since 2015, Uppsala Tjej- och Transjour has run school sessions for secondary school pupils in Uppsala municipality, from year 9 to year 2. The school session is a 120-minute workshop and focuses on increasing knowledge and changing attitudes about consent, reciprocity and sexual violence. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence Prevention Intervention Evaluation Among Youth
- What is being tested?
- School sessions on consent, reciprocity and sexual violence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 11 Oct 2023to 31 Dec 2024
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages between 15-18 y/o
- Participant goes to a school that is part of the study
Who cannot join
- Person is under the age of 15 y/o or over the age of 18 y/o
- Person is not enrolled in one of the schools who are part of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a School Intervention to Influence Knowledge, Attitudes and Behaviour Regarding Consent and Sexual Violence in Adolescents.
Since 2015, Uppsala Tjej- och Transjour has run school sessions for secondary school pupils in Uppsala municipality, from year 9 to year 2. The school session is a 120-minute workshop and focuses on increasing knowledge and changing attitudes about consent, reciprocity and sexual violence. The intervention aims to increase participants' knowledge about consent, reciprocity, sex, sexuality and sexual violence in order to create positive attitudinal changes around gender and sexual violence and influence behaviour. The purpose of the study is to evaluate the effect of Uppsala Tjej- och Transjour's school intervention on young people's knowledge, attitudes and behaviour regarding consent, reciprocity and sexual violence. A cluster randomised controlled trial with 16 clusters (89 participants in each cluster) in each arm, a total of 32 clusters. Schools are randomised after baseline measurement to receive the intervention in autumn 2023 or spring 2024 (waiting list). Data collection is done through a questionnaire at two measurement points. A baseline measurement before the intervention (T1) and measurement two (T2) 6 months later. There are still few violence prevention programmes in Sweden that have been evaluated for effectiveness, and several programmes come from the USA. This study is based on a Swedish material and constitutes an important contribution to the development of more effective methods for violence prevention and increased insights into reciprocity and consent.
Read the detailed description
Background: Young people and LGBTQ+ people are currently, and have long been, over-represented as victims of sexual offences in Sweden. This is clearly illustrated in both statistics from the Swedish National Council for Crime Prevention and in the scientific literature. In order to counteract and prevent violence among young people and boys' violence against girls, the government has created a specific action programme that particularly emphasises preventive measures with the aim of improving knowledge and developing methods. The action programme emphasises the role of schools in working to implement a culture of consent and enhanced violence prevention.
Since 2015, Uppsala Tjej- och Transjour has run school sessions for secondary school pupils in Uppsala municipality, from year 9 to year 2. The schools themselves order the sessions and allocate time for them. The school session is a 120-minute workshop and focuses on increasing knowledge and changing attitudes about consent, reciprocity and sexual violence. The intervention aims to increase participants' knowledge about consent, reciprocity, sex, sexuality and sexual violence in order to create positive attitudinal changes around gender and sexual violence and influence behaviour. The intervention uses awareness-raising materials as well as exercises and group discussion. Uppsala Tjej- och Transjour has a unique position in society where they work closely with young people and the problems that young people experience in everyday life.
Uppsala Tjej- och Transjour, together with Uppsala University, has received funding from the Swedish Gender Equality Agency for an impact evaluation of the school sessions.
Purpose: The purpose of the study is to evaluate the effect of Uppsala Tjej- och Transjour's school intervention on young people's knowledge, attitudes and behaviour regarding consent, reciprocity and sexual violence.
Method: A cluster randomised controlled trial with 16 clusters (89 participants in each cluster) in each arm, a total of 32 clusters. A cluster can be a whole (smaller) school with three parallel classes or a programme in a secondary school with three parallel classes. The schools register as usual, but are randomised after the baseline measurement to receive the intervention in autumn 2023 or spring 2024 (waiting list). Data collection is done through a questionnaire at two measurement points. A baseline measurement before the intervention (T1) and measurement two (T2) 6 months later.
Significance: Violence prevention has previously mainly focused on victims and perpetrators and excluded men from being active participants in prevention programmes. There are still few violence prevention programmes in Sweden that have been evaluated for effectiveness, and several programmes come from the USA. This study is based on a Swedish material and constitutes an important contribution to the development of more effective methods for violence prevention and increased insights into reciprocity and consent.
- Being tested
- School sessions on consent, reciprocity and sexual violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School sessions on consent, reciprocity and sexual violenceBehavioural
The intervention consists of a 120-minute workshop led by a representative from Uppsala Tjej- och Transjour and aims to reduce the vulnerability and prevalence of sexual harassment, sexual violence and to counteract men's violence against women and violence in close relationships by raising awareness among pupils, school staff and guardians about sexual health among young people. The workshop covers areas of consent, reciprocity and sexual violence. The participants will do several valuation based and discussion based exercises regarding these topics and discuss issues, legality, and norms during the time.
| Study group | Role | What they receive |
|---|---|---|
| Intervention-arm | Experimental | Immediate scheduling and participation of Uppsala Tjej- och Transjour's intervention. Receives: Behavioral: School sessions on consent, reciprocity and sexual violence |
| Wait-list control-arm | Active comparator | Wait-listed group, will await intervention for 6-8 months. After follow-up measurements, this group will receive the intervention. Receives: Behavioral: School sessions on consent, reciprocity and sexual violence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
Intervention aims at increasing knowledge about the topics of sexual violence, consent and reciprocity. Participants have answered a survey containing questions on knowledge on these topics which will be followed up 5 months after the intervention has been received and compared with wait-list control-group.
Measured: Baseline, T2 5-6 months later.
Attitudes
Intervention aims at positively effecting attitudes about the topics of sexual violence, consent and reciprocity. Participants have answered a survey containing questions where participants attitudes are measured on these topics. These types of question ask participants to value scenarios or situations presented for them on the topics of the intervention which will be followed up 5 months after the intervention has been received and compared with wait-list control-group.
Measured: Baseline, T2 5-6 months later.
Secondary outcomes (1)
Behaviour
Intervention aims at reducing self-assessed prevalence of different forms of sexual violence. Questions in the survey taken at baseline and in follow-up measurements asks participants questions on their self-assessed experiences with sexual harassment and sexual violence. This will be compared post-intervention with control-group.
Measured: Baseline, T2 5-6 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start11 Oct 2023
- Primary completion30 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence Prevention Intervention Evaluation Among YouthStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala Tjej- och Transjour
- Responsible party
- Principal investigator, Anna Sarkadi, Uppsala University
- Investigators
- Anna Sarkadi, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132074
- Sponsor's protocol ID
- 2023-04343-01
- Other IDs
- 2023
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a School Intervention to Influence Knowledge, Attitudes and Behaviour Regarding Consent and Sexual Violence in Adolescents.
- ClinicalTrials.gov ID
- NCT06132074
- Acronym / sponsor ID
- 2023-04343-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala Tjej- och Transjour
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Nov 2023 (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.
Since 2015, Uppsala Tjej- och Transjour has run school sessions for secondary school pupils in Uppsala municipality, from year 9 to year 2. The school session is a 120-minute workshop and focuses on increasing knowledge and changing attitudes about consent, reciprocity and sexual violence. The intervention aims to increase participants' knowledge about consent, reciprocity, sex, sexuality and sexual violence in order to create positive attitudinal changes around gender and sexual violence and influence behaviour. The purpose of the study is to evaluate the effect of Uppsala Tjej- och Transjour's school intervention on young people's knowledge, attitudes and behaviour regarding consent, reciprocity and sexual violence. A cluster randomised controlled trial with 16 clusters (89 participants in each cluster) in each arm, a total of 32 clusters. Schools are randomised after baseline measurement to receive the intervention in autumn 2023 or spring 2024 (waiting list). Data collection is done through a questionnaire at two measurement points. A baseline measurement before the intervention (T1) and measurement two (T2) 6 months later. There are still few violence prevention programmes in Sweden that have been evaluated for effectiveness, and several programmes come from the USA. This study is based on a Swedish material and constitutes an important contribution to the development of more effective methods for violence prevention and increased insights into reciprocity and consent.
Detailed description
Background: Young people and LGBTQ+ people are currently, and have long been, over-represented as victims of sexual offences in Sweden. This is clearly illustrated in both statistics from the Swedish National Council for Crime Prevention and in the scientific literature. In order to counteract and prevent violence among young people and boys' violence against girls, the government has created a specific action programme that particularly emphasises preventive measures with the aim of improving knowledge and developing methods. The action programme emphasises the role of schools in working to implement a culture of consent and enhanced violence prevention.
Since 2015, Uppsala Tjej- och Transjour has run school sessions for secondary school pupils in Uppsala municipality, from year 9 to year 2. The schools themselves order the sessions and allocate time for them. The school session is a 120-minute workshop and focuses on increasing knowledge and changing attitudes about consent, reciprocity and sexual violence. The intervention aims to increase participants' knowledge about consent, reciprocity, sex, sexuality and sexual violence in order to create positive attitudinal changes around gender and sexual violence and influence behaviour. The intervention uses awareness-raising materials as well as exercises and group discussion. Uppsala Tjej- och Transjour has a unique position in society where they work closely with young people and the problems that young people experience in everyday life.
Uppsala Tjej- och Transjour, together with Uppsala University, has received funding from the Swedish Gender Equality Agency for an impact evaluation of the school sessions.
Purpose: The purpose of the study is to evaluate the effect of Uppsala Tjej- och Transjour's school intervention on young people's knowledge, attitudes and behaviour regarding consent, reciprocity and sexual violence.
Method: A cluster randomised controlled trial with 16 clusters (89 participants in each cluster) in each arm, a total of 32 clusters. A cluster can be a whole (smaller) school with three parallel classes or a programme in a secondary school with three parallel classes. The schools register as usual, but are randomised after the baseline measurement to receive the intervention in autumn 2023 or spring 2024 (waiting list). Data collection is done through a questionnaire at two measurement points. A baseline measurement before the intervention (T1) and measurement two (T2) 6 months later.
Significance: Violence prevention has previously mainly focused on victims and perpetrators and excluded men from being active participants in prevention programmes. There are still few violence prevention programmes in Sweden that have been evaluated for effectiveness, and several programmes come from the USA. This study is based on a Swedish material and constitutes an important contribution to the development of more effective methods for violence prevention and increased insights into reciprocity and consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-arm | Experimental | Behavioral: School sessions on consent, reciprocity and sexual violenceImmediate scheduling and participation of Uppsala Tjej- och Transjour's intervention. |
| Wait-list control-arm | Active comparator | Behavioral: School sessions on consent, reciprocity and sexual violenceWait-listed group, will await intervention for 6-8 months. After follow-up measurements, this group will receive the intervention. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages between 15-18 y/o
- Participant goes to a school that is part of the study
Key exclusion criteria (2 listed)
- Person is under the age of 15 y/o or over the age of 18 y/o
- Person is not enrolled in one of the schools who are part of the study
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 |
|---|---|---|
| School sessions on consent, reciprocity and sexual violenceThe intervention consists of a 120-minute workshop led by a representative from Uppsala Tjej- och Transjour and aims to reduce the vulnerability and prevalence of sexual harassment, sexual violence and to counteract men's violence against women and violence in close relationships by raising awareness among pupils, school staff and guardians about sexual health among young people. The workshop covers areas of consent, reciprocity and sexual violence. The participants will do several valuation based and discussion based exercises regarding these topics and discuss issues, legality, and norms during the time. | Behavioural | Intervention-arm, Wait-list control-arm |
Primary outcome
Knowledge
Time frame: Baseline, T2 5-6 months later.
Intervention aims at increasing knowledge about the topics of sexual violence, consent and reciprocity. Participants have answered a survey containing questions on knowledge on these topics which will be followed up 5 months after the intervention has been received and compared with wait-list control-group.
Attitudes
Time frame: Baseline, T2 5-6 months later.
Intervention aims at positively effecting attitudes about the topics of sexual violence, consent and reciprocity. Participants have answered a survey containing questions where participants attitudes are measured on these topics. These types of question ask participants to value scenarios or situations presented for them on the topics of the intervention which will be followed up 5 months after the intervention has been received and compared with wait-list control-group.
1 secondary outcome
Behaviour
Time frame: Baseline, T2 5-6 months later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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.
Anna Sarkadi, Professor principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School sessions on consent, reciprocity and sexual violence in people with Violence Prevention Intervention Evaluation Among Youth, run by Uppsala University at 1 site in 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 2 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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 Sweden. 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?
Results are not available in the source record.
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 (time frame: Baseline, T2 5-6 months later.). The study lists 2 primary outcomes in all. 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 30 Jan 2024.