Bullying VictimisationNCT00597337
Effectiveness of the FearNot!v.2.0 Software in Reducing Bullying Victimisation Among Primary School Children
A study testing FearNot in people with Bullying Victimisation, run by University of Warwick at 1 site in United Kingdom.
Trial summary
This study will evaluate the effectiveness of a virtual learning treatment in reducing bullying among primary school children in the UK and Germany. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying Victimisation
- What is being tested?
- FearNot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,129 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2007to May 2008
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mixed
- Not currently involved in intervention studies specific to countering bullying
- Access to computers that are compatible to run FearNot!v.2.0 (for intervention schools)
- Age between 8-11
- Passive parental consent
Who cannot join
- Enrolled in special education schools
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Virtual Learning Environment to Reduce Bullying: Evaluation of the FearNot!v.2.0 Intervention in Primary Schools in England and Germany
This study will evaluate the effectiveness of a virtual learning treatment in reducing bullying among primary school children in the UK and Germany.
Read the detailed description
In this study, a virtual learning environment application called FearNot!v.2.0 will be evaluated as a way to improve the quality of life in schools by altering children's attitudes and behavior towards bullying.
Participants will be assigned to either the intervention or the control group. The intention was to assign randomly, however, only a minority of primary schools have the computer facilities to run the software with all pupils participating. Thus, assignment is based on the school computer compatibility with the FearNot!v.2.0 software for intervention versus control group controlling for social variables. Participants in the intervention group will interact with the software during 30-minute sessions once a week for a total of 3 weeks while participants in the control group will follow the normal curriculum.
The FearNot! narrative comprises a number of emergent episodes, which play out like an improvisational drama. During each of these emergent episodes, the characters will act out their roles resulting in a dramatic movie-like display on the computer's monitor. In between each of these episodes, the child can interact with the victim character. He/she can learn how the character feels, and offer them coping strategy advice as to how to behave in the following episode.
Outcomes will be assessed through student questionnaires at baseline, one week, and four weeks after treatment. In addition, classroom teachers will be asked to complete the Teacher Incidence of Bullying Scale at baseline and 4 weeks after the treatment.
- Conditions
- Bullying Victimisation
- Being tested
- FearNot
- Keywords
- bullying, victimisation, aggressive behavior
- Medical subject headings
- Bullying, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FearNotBehavioural
Behavioral: Three sessions of FearNot!v.2.0 software interaction over a three-week period (each session lasting approximately 30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receiving FearNot Receives: Behavioral: FearNot |
| 2 | No intervention | Control: Treatment as usual (normal curriculum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bullying victimisation - Participant Roles Questionnaire
Measured: Measured 1 week post-treatment and at 4 week follow-up
Secondary outcomes (4)
Knowledge about Bullying and Coping Strategies Knowledge Questionnaire
Measured: Measured 1-week post-treatment and at 4-week follow-up
Peer nominations of defenders
Measured: Measured 1 week post-treatment and at 4 week follow-up
Hymel, Rocke & Bonanno Moral Disengagement Questionnaire
Measured: Measured 1 week post-treatment and at 4 week follow-up
Janke and Janke Adjective Word List (adapted)
Measured: Measured after each treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
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 Bullying VictimisationStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg, University of Hertfordshire, University of Bamberg, European Commission
- Investigators
- Dieter Wolke, PhD, Principal investigator, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597337
- Sponsor's protocol ID
- WAR-IST-4-027656-STP
- Other IDs
- IST-4-027656-STP
- Status last verified
- Oct 2008
- First submitted
- 9 Jan 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Sapouna M, Wolke D, Vannini N, Watson S, Woods S, Schneider W, Enz S, Hall L, Paiva A, Andre E, Dautenhahn K, Aylett R. Virtual learning intervention to reduce bullying victimization in primary school: a controlled trial. J Child Psychol Psychiatry. 2010 Jan;51(1):104-12. doi: 10.1111/j.1469-7610.2009.02137.x. Epub 2009 Aug 24.
PubMed 19703096
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Virtual Learning Environment to Reduce Bullying: Evaluation of the FearNot!v.2.0 Intervention in Primary Schools in England and Germany
- ClinicalTrials.gov ID
- NCT00597337
- Acronym / sponsor ID
- WAR-IST-4-027656-STP
- Conditions
- Bullying Victimisation
- Keywords
- bullying, victimisation, aggressive behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- University of Wuerzburg, University of Hertfordshire, University of Bamberg, European Commission
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Jan 2008 (estimated)
- 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.
This study will evaluate the effectiveness of a virtual learning treatment in reducing bullying among primary school children in the UK and Germany.
Detailed description
In this study, a virtual learning environment application called FearNot!v.2.0 will be evaluated as a way to improve the quality of life in schools by altering children's attitudes and behavior towards bullying.
Participants will be assigned to either the intervention or the control group. The intention was to assign randomly, however, only a minority of primary schools have the computer facilities to run the software with all pupils participating. Thus, assignment is based on the school computer compatibility with the FearNot!v.2.0 software for intervention versus control group controlling for social variables. Participants in the intervention group will interact with the software during 30-minute sessions once a week for a total of 3 weeks while participants in the control group will follow the normal curriculum.
The FearNot! narrative comprises a number of emergent episodes, which play out like an improvisational drama. During each of these emergent episodes, the characters will act out their roles resulting in a dramatic movie-like display on the computer's monitor. In between each of these episodes, the child can interact with the victim character. He/she can learn how the character feels, and offer them coping strategy advice as to how to behave in the following episode.
Outcomes will be assessed through student questionnaires at baseline, one week, and four weeks after treatment. In addition, classroom teachers will be asked to complete the Teacher Incidence of Bullying Scale at baseline and 4 weeks after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: FearNotReceiving FearNot |
| 2 | No intervention | –Control: Treatment as usual (normal curriculum) |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Mixed
- Not currently involved in intervention studies specific to countering bullying
- Access to computers that are compatible to run FearNot!v.2.0 (for intervention schools)
- Age between 8-11
- Passive parental consent
Key exclusion criteria (1 listed)
- Enrolled in special education schools
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 |
|---|---|---|
| FearNotBehavioral: Three sessions of FearNot!v.2.0 software interaction over a three-week period (each session lasting approximately 30 minutes) | Behavioural | 1 |
Primary outcome
Bullying victimisation - Participant Roles Questionnaire
Time frame: Measured 1 week post-treatment and at 4 week follow-up
4 secondary outcomes
Knowledge about Bullying and Coping Strategies Knowledge Questionnaire
Time frame: Measured 1-week post-treatment and at 4-week follow-up
Peer nominations of defenders
Time frame: Measured 1 week post-treatment and at 4 week follow-up
Hymel, Rocke & Bonanno Moral Disengagement Questionnaire
Time frame: Measured 1 week post-treatment and at 4 week follow-up
Janke and Janke Adjective Word List (adapted)
Time frame: Measured after each treatment session
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 18 Dec 2008.
- Derived from this study: PubMed 19703096Sapouna M, Wolke D, Vannini N, Watson S, Woods S, Schneider W, Enz S, Hall L, Paiva A, Andre E, Dautenhahn K, Aylett R. Virtual learning intervention to reduce bullying victimization in primary school: a controlled trial. J Child Psychol Psychiatry. 2010 Jan;51(1):104-12. doi: 10.1111/j.1469-7610.2009.02137.x. Epub 2009 Aug 24.
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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.
Dieter Wolke, PhD principal investigator
University of Warwick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FearNot in people with Bullying Victimisation, run by University of Warwick at 1 site in United Kingdom.
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 5 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 18 Dec 2008. 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 United Kingdom. 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?
Bullying victimisation - Participant Roles Questionnaire (time frame: Measured 1 week post-treatment and at 4 week follow-up). 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 NCT00597337, 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 18 Dec 2008.