|- candidate number||21813|
|- NTR Number||NTR5069|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mrt-2015|
|- Secondary IDs||2015-02 CMO Arnhem-Nijmegen: NL50023.091.14. |
|- Public Title||A randomized controlled trial testing the effect of the video game ‘Mindlight’ on anxiety symptoms in children with an Autism Spectrum Disorder.|
|- Scientific Title||A randomized controlled trial testing the effect of the video game ‘Mindlight’ on anxiety symptoms in children with an Autism Spectrum Disorder.|
|- hypothesis||In the present study, it will be investigated whether the game Mindlight is effective in decreasing anxiety symptoms of a Dutch clinical sample of children with an autism spectrum disorder in the age of 8-16 years old. The study is a randomized controlled trial with two conditions (experimental and control group). It is expected that the children who play Mindlight (experimental group) will show lower levels of anxiety symptoms at follow-up, compared to the children in the control group.|
|- Healt Condition(s) or Problem(s) studied||Anxiety, Autism Spectrum Disorders (ASDs)|
|- Inclusion criteria||1. Age between 8-16 years old.|
2. Diagnosis of an Autism spectrum disorder (DSM IV; Autism, Asperger, PDD-NOS).
3. Subclinical score on total scale and/or one or more subscales on SCAS-C and/or SCAS-P.
4. Sufficient knowledge of the Dutch language.
|- Exclusion criteria||1. Absence of parental permission.|
2. Presence of prominent suicidal ideation.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||1-jun-2018|
|- Target number of participants||120|
|- Interventions||The children with an autism spectrum disorder and with comorbid elevated anxiety symptoms are randomly assigned to the experimental or control condition. The children in the experimental condition will play Mindlight for one hour per week during six weeks. The children in the control condition will play a control game for one hour per week during six weeks. Moreover, both children in the experimental and control condition will fill in questionnaires before the first gaming session, after the last gaming session and at 3-months follow-up. Parents and teachers will also fill in questionnaires on the same time points. Anxiety symptoms will be the primary outcome. Finally, parents will undergo a semi-structured interview (ADIS-P) before the first gaming session and at 3-months follow-up to assess whether Mindlight has an effect on the presence of clinical anxiety disorders in the participating children.|
|- Primary outcome||Anxiety: Spence Children’s Anxiety Scale (SCAS)|
|- Secondary outcome||1. Anxiety of the child according to the parents: Spence Child Anxiety Scale for Parents (SCAS-P).|
2. The presence of anxiety disorders according to the parents: Anxiety Disorders Interview Schedule for DSM-IV, Parent version (ADIS-P).
3. Depressive symptoms: Child Depression Inventory 2 (CDI 2).
4. Depression according to the parents: Child Depression Inventory 2 for parents (CDI 2:P).
5. Social functioning according to the parents and teacher: Vragenlijst voor Inventarisatie van Sociaal gedrag van Kinderen (VISK).
6. Internalizing and externalizing behaviour problems according to the parents and teacher: Strengths and Difficulties Questionnaire (SDQ).
7. Treatment expectancies according to child and parents will: Parent Expectancies for Therapy Scale (PETS).
|- Timepoints||1. Before the first session (baseline)|
2. After the last session (post-intervention)
3. Three months after the last session (3-months follow-up)
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Msc. Lieke Wijnhoven|
|- CONTACT for SCIENTIFIC QUERIES|| Lieke Wijnhoven|
|- Sponsor/Initiator ||GGZ Oost Brabant|
(Source(s) of Monetary or Material Support)
|Commissie Onderzoek & Innovatie GGZ Oost Brabant , Radboud Universiteit Nijmegen, Behavioural Science Institute|
|- Brief summary||In this randomized controlled trial it will be investigated whether the intervention game ‘Mindlight’ is effective in reducing anxiety symptoms among 8-16 year-old children with an autism spectrum disorder. Participating children will be randomly assigned to the experimental and control condition. Children in the experimental condition will play Mindlight for one hour per week during six weeks. Children in the control condition will play a control game for one hour per week during six weeks. Assessments of primary and secondary outcomes will be conducted at baseline, at post-intervention and at 3-months follow-up.|
|- Main changes (audit trail)|
|- RECORD||18-mrt-2015 - 20-apr-2015|