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A randomized controlled trial to test the effectiveness of an immersive 3D video game in preventing anxiety.


- candidate number16401
- NTR NumberNTR4379
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2014
- Secondary IDsECSW2013-0410-140 
- Public TitleA randomized controlled trial to test the effectiveness of an immersive 3D video game in preventing anxiety.
- Scientific TitleA randomized controlled trial to test the effectiveness of an immersive 3D video game in preventing anxiety.
- ACRONYM
- hypothesisThe effectiveness of a school-based immersive video game (Dojo) in preventing anxiety will be tested in a Dutch sample of adolescents with elevated anxiety symptoms. It is expected that the adolescents who receive the intervention video game will show lower levels of anxiety symptoms during post-test and follow-up, compared to the control group.
- Healt Condition(s) or Problem(s) studiedAnxiety, Prevention, Adolescents, Biofeedback
- Inclusion criteria1. Adolescents in 7th, 8th and 9th grade, middle school (ages 12-15); 2. Screening participation: passive consent from adolescents and parents; 3. Elevated anxiety symptoms. Participants with a SCAS score above a 1 SD cut off score on at least two subscales or more on the screening will be included; 4. After screening: active consent from adolescents and parents.
- Exclusion criteria1. No passive or active consent from adolescents and parents; 2. Adolescents currently receiving mental health care.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-feb-2014
- planned closingdate11-sep-2014
- Target number of participants120
- InterventionsAdolescents with elevated anxiety symptoms are randomly assigned to the intervention or control condition. 1. Adolescents in the intervention condition will play the video game Dojo over 6 sessions of one hour spread over three weeks. They will receive Dojo at their school after school time. Adolescents will fill in questionnaires before the first play session, after the last play session and three months after the last play session. 2. Adolescents in the control conditon will play the video game Rayman 2: The Great Escape over 6 sessions of one hour spread over three weeks. They will receive Rayman at their school after school time. Adolescents will fill in questionnaires before the first play session, after the last play session and three months after the last play session.
- Primary outcomeAnxiety symptoms: Spence Children Anxiety Scale (SCAS).
- Secondary outcome1. Strengths and Difficulties Questionnaire (SDQ). 2. Coping Questionnaire Child (CQ-C). 3. Self Efficacy Questionnaire for Children (SEQ-C).
- Timepoints1. Screening: primary outcome; 2. Pretreatment: all primary and secondary outcomes (one week before first session); 4. Posttreatment: all primary and secondary outcomes (one week after last session); 5. Follow-up: all primary and secondary outcomes (three months after posttreatment).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES H. Scholten
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Isabela Granic
- Sponsor/Initiator Radboud University Nijmegen, Behavioural Science Institute
- Funding
(Source(s) of Monetary or Material Support)
Radboud Universiteit Nijmegen, Behavioural Science Institute
- PublicationsN/A
- Brief summaryIn this randomized controlled trial (RCT with 2 conditions, intervention and control condition), the effectiveness of a school-based immersive video game Dojo will be tested in a Dutch sample of adolescents with elevated anxiety symptoms. Adolescents with elevated anxiety symptoms are randomly assigned to one of two conditions. The intervention condition (Dojo) will consist of 6 play sessions of 60 minutes spread over three weeks at school after school time. The control condition (Rayman 2: The Great Escape) will consist of 6 play sessions of 60 minutes spread over three weeks at school after school time. Measurements of primary and secondary outcomes will be conducted in both conditions at baseline, one week after the last session and three months after posttreatment.
- Main changes (audit trail)
- RECORD11-feb-2014 - 28-mrt-2014


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