|- candidate number||16799|
|- NTR Number||NTR4477|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2014|
|- Secondary IDs||2013-1811-154 ECG |
|- Public Title||A randomized controlled trail to evaluate the effectiveness of a videogame intervention (Dojo) for anxious-aggressive adolescents.|
|- Scientific Title||A randomized controlled trail to evaluate the effectiveness of a videogame intervention (Dojo) for anxious-aggressive adolescents.|
|- hypothesis||The main aim of this project is to conduct a randomized controlled trail (RCT) to evaluate the effectiveness of the videogame Dojo as an intervention for anxious-aggressive youths in residential treatment. The effectiveness of Dojo will be compared to treatment as usual in a Dutch sample of adolescent youths with clinically elevated levels of anxiety and aggression. It is hypothesized that the youths who play Dojo will show lower levels of anxiety and aggression in comparison with the youths who receive treatment as usual at measurements post-treatment and four month follow-up.|
|- Healt Condition(s) or Problem(s) studied||Aggression, Anxiety, Intervention, Biofeedback, Adolescents|
|- Inclusion criteria||1. Youths in residential treatment for conduct problems (ages 12-17);
2. Informed consent from youths and parents (or legal guardian);
3. Clinically elevated symptoms of anxiety, based on therapist judgment or the Youth Self Report.
|- Exclusion criteria||1. Diagnosis of an Autism Spectrum Disorder.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-mrt-2014|
|- planned closingdate||30-nov-2014|
|- Target number of participants||40|
|- Interventions||Youths are randomly assigned to one of two conditions.
1. The experimental condition, ‘Dojo’, will consist of 8 sessions of 30 minutes of playing the videogame ‘Dojo’ (4 weeks, twice a week). These sessions will take place in their therapy buildings during school time under supervision of a researcher.
2. The control condition will receive treatment as usual, a cognitive behavioural based therapy approach.
|- Primary outcome||Aggressive behavior: Strengths and Difficulties Questionnaire (SDQ). Self-report and group home mentor report.
Anxiety symptoms: Spence Children’s Anxiety Scale (SCAS). Self-report and group home mentor report.
|- Secondary outcome||1. Self-efficacy: Self-Efficacy Questionnaire for Children (SEQ-C). Self-report.|
|- Timepoints||1. Pretreatment (all primary and secondary outcomes);
2. Posttreatment (all primary and secondary outcomes);
3. Four months after the last session (follow-up; all primary and secondary outcomes)
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| A.A.T. Schuurmans|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. I. Granic|
|- Sponsor/Initiator ||Radboud University Nijmegen, Behavioural Science Institute|
(Source(s) of Monetary or Material Support)
|Radboud Universiteit Nijmegen, Behavioural Science Institute, Pluryn, Gamedesk|
|- Brief summary||In this randomized controlled trial (RCT with two conditions, intervention and control group) the effectiveness of the videogame Dojo will be compared to treatment as usual in a Dutch sample of adolescent youths with clinically elevated levels of aggression and anxiety. The experimental condition, ‘Dojo’, will consist of eight sessions of 30 minutes of playing the videogame ‘Dojo’. The control condition will receive treatment as usual, a cognitive behavioural based therapy approach. Measurements of primary and secondary outcomes will be conducted in the experimental and control group at baseline, immediately after treatment, and four months after the last session. |
|- Main changes (audit trail)|
|- RECORD||11-mrt-2014 - 21-apr-2014|