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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00597337
Other study ID # WAR-IST-4-027656-STP
Secondary ID IST-4-027656-STP
Status Completed
Phase N/A
First received January 9, 2008
Last updated December 17, 2008
Start date November 2007
Est. completion date May 2008

Study information

Verified date October 2008
Source University of Warwick
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeGermany: Ethics Commission
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1129
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 11 Years
Eligibility Inclusion Criteria for schools:

- 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)

Inclusion Criteria for participants:

- Age between 8-11

- Passive parental consent

Exclusion Criteria:

- Enrolled in special education schools

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
FearNot
Behavioral: Three sessions of FearNot!v.2.0 software interaction over a three-week period (each session lasting approximately 30 minutes)

Locations

Country Name City State
United Kingdom University of Warwick Coventry

Sponsors (5)

Lead Sponsor Collaborator
University of Warwick European Commission, University of Bamberg, University of Hertfordshire, University of Wuerzburg

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bullying victimisation - Participant Roles Questionnaire Measured 1 week post-treatment and at 4 week follow-up No
Secondary Knowledge about Bullying and Coping Strategies Knowledge Questionnaire Measured 1-week post-treatment and at 4-week follow-up No
Secondary Peer nominations of defenders Measured 1 week post-treatment and at 4 week follow-up No
Secondary Hymel, Rocke & Bonanno Moral Disengagement Questionnaire Measured 1 week post-treatment and at 4 week follow-up No
Secondary Janke and Janke Adjective Word List (adapted) Measured after each treatment session No

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