Effectiveness of the FearNot!v.2.0 Software in Reducing B... | NCT00597337

Studies
Effectiveness of the FearNot!v.2.0 Software in Reducing Bullying Victimisation Among Primary School Children

NCT00597337

Sponsor

University of Warwick

Status

Completed

Last Update Posted

Dec 18, 2008Estimated

Enrollment

1,129Actual

Phase

Not Applicable

Conditions

Bullying Victimisation

Interventions

FearNot

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IST-4-027656-STP

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jan 9, 2008

First Submission Date that Met QC Criteria

Jan 17, 2008

First Posted Date

Jan 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2008

Last Update Posted Date

Dec 18, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of WarwickOTHER

Collaborators

Name	Class
University of Wuerzburg	OTHER
University of Hertfordshire	OTHER
University of Bamberg	OTHER
European Commission

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Receiving FearNot	Behavioral: FearNot
2	No Intervention	Control: Treatment as usual (normal curriculum)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FearNot	Behavioral	Behavioral: Three sessions of FearNot!v.2.0 software interaction over a three-week period (each session lasting approximately 30 minutes)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bullying victimisation - Participant Roles Questionnaire		Measured 1 week post-treatment and at 4 week follow-up

Secondary Outcomes

Measure	Description	Time Frame
Knowledge about Bullying and Coping Strategies Knowledge Questionnaire		Measured 1-week post-treatment and at 4-week follow-up
Peer nominations of defenders		Measured 1 week post-treatment and at 4 week follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dieter Wolke, PhD	University of Warwick	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Warwick		Coventry		CV4 7AL	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19703096	Derived	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.

ID	Term
D058445	Bullying
D000374	Aggression

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D000071277	Harassment, Non-Sexual
D012919	Social Behavior