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A randomized controlled trial using a video game to reduce anxiety in children.


- candidate number16382
- NTR NumberNTR4366
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-feb-2014
- Secondary IDsn/a n/a
- Public TitleA randomized controlled trial using a video game to reduce anxiety in children.
- Scientific TitleA randomized controlled trial using a video game to reduce anxiety in children.
- ACRONYM
- hypothesisThis study will use a Randomized Controlled Trial (RCT) to evaluate the effectiveness and underlying mechanisms of the video game Mindlight, a newly developed anxiety-reducing training for children. Mindlight and a control game will be played for several sessions by Dutch primary school children (8–12 years old) with elevated levels of anxiety. It is hypothesized that children playing Mindlight will experience reduced levels of anxiety in comparison with the control group. Attentional bias will be examined as mediator of this effect, and children’s coping abilities and anxiety and stress level of parents will be included as moderators.
- Healt Condition(s) or Problem(s) studiedAnxiety, Anxiety, Anxiety disorders
- Inclusion criteriaPrimary school children in grades 5 till 8 (8-12 years old) will be screened using the Spence Children’s Anxiety Scale. Passive consent from parents is required for participating in the screening. All children scoring > 1 SD above the mean on at least two subscales (except for the OCD subscale) or on total score of the SCAS will be contacted to join the training. Active consent from the parents is required to participate in the training.
- Exclusion criteriaParents declining participation of their child in either the first (passive) or second (active) consent opportunity or children scoring < 1 SD above the mean on subscales (except for the OCD subscale) or on total score of the SCAS.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-feb-2014
- planned closingdate30-sep-2014
- Target number of participants140
- InterventionsChildren will be randomly assigned in either the experimental or the control condition. Both conditions start with a pre-test where anxiety is measured via questionnaires and attentional bias via the dot-probe task and the visual search task. The parents will also fill out questionnaires this week. The next weeks, the groups will play a video game for 50 minutes. The experimental condition plays Mindlight, while the control condition plays Max and the Magic Marker. This will be done for 3 weeks, 2 times a week at the school (after class). After this training, the children will complete the same questionnaires and attentional bias measuring instruments as used in the pre-test. The parents will also receive questionnaires. 3 months later, a follow up test will use the same measurements again.
- Primary outcome- Child scores on the Spence Children's Anxiety Scale (SCAS-C) - Parent scores on the Spence Children's Anxiety Scale (SCAS-P)
- Secondary outcome- Attentional bias (reaction times on dot-probe and visual search task) - Coping questionnaire for the child (CQ C) - Self-efficacy questionnaire for the child (SEQ-C) - Strengths and difficulties questionnaire for the child (SDQ) - Strength and difficulties questionnaire according to parent (SDQP) - Anxiety, depression and stress scale for parents (DASS-21)
- Timepoints- Screening using SCAS-C - Pre-test using all primary & secondary instruments (1 week before start intervention) - Post-test using all primary & secondary instruments except demographics (1 week after training) - Follow-up using all primary & secondary instruments (3 months after post-test).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc E.A. Schoneveld
- CONTACT for SCIENTIFIC QUERIESMSc E.A. Schoneveld
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
NWO, Radboud Universiteit Nijmegen, Behavioural Science Institute
- PublicationsN/A
- Brief summaryIn this randomized controlled trial (RCT with 2 conditions, intervention and control group) the effectiveness of an anxiety-reducing training in the form of a video game (Mindlight) will be examined. Children (ages 8-12) with elevated levels of anxiety are randomly assigned to play a video game (either Mindlight or Max and the Magic Marker) 6 times for one hour after school. The aims are to evaluate the effectiveness and gain insight into the underlying mechanisms. Measurements of primary and secondary outcomes will be conducted in the intervention directly before and after the training and at 3 months follow up.
- Main changes (audit trail)21-3-14: trial overgezet naar website: LH
- RECORD7-feb-2014 - 21-mrt-2014


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