|- candidate number||21965|
|- NTR Number||NTR5153|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-apr-2015|
|- Secondary IDs||MEC-2015-047 METC Erasmus MC|
|- Public Title||Participation of children and adolescents after mild traumatic brain injury|
|- Scientific Title||Participation of children and adolescents during the first six months post mild traumatic brain injury|
|- ACRONYM||Brains Ahead!|
|- hypothesis||To examine participation of children and adolescents during the first six months after mild traumatic brain injury and to identify predictors for this outcome. Furthermore, to examine the effect of an early intervention, meant to prevent participation problems at six months post injury, compared to the usual care.
We hypothesize that the early intervention is more effective in preventing long-term problems on activity and participation after mild traumatic brain injury, compared to the usual care.
|- Healt Condition(s) or Problem(s) studied||Traumatic brain injury, Children, Adolescents|
|- Inclusion criteria||Children and adolescents aged 6-18 years.|
Diagnosed with mild traumatic brain injuryin one of our participating hospitals in the past week.
|- Exclusion criteria||Limited understandig of the Dutch language.|
Reoccuring brain injury or central neurological disease during the follow-up period.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-mei-2015|
|- planned closingdate||31-dec-2017|
|- Target number of participants||140|
|- Interventions||Controlgroup receives care as usual consisting of a concise information brochure.|
Interventiongroup receives care as usual and casemanagement, consisting of:
- Inventarisation of complaints/problems after the injury;
|- Primary outcome||Activity and participation, measured with the Child and Adolescent Scale of Participation - Dutch Language Version (parentforms).|
|- Secondary outcome||Participation form children's persepective: Child and Adolescent Scale of Participation (child version) and Children's Assessment of Participation and Enjoyment.|
Cognition and behavior - Child Behavior Checklist.
Family functioning - Family Assessment Device.
Fatigue - PedsQL vermoeidheidsschaal.
Quality of life - PedsQL kwaliteit van leven schaal.
Post concussieve symptomen - Health and Behavior Inventory.
Posttraumatische stress symptomen - Schokverwerkingslijst.
Sensory processing - Sensory Profile (short version and AASP).
|- Timepoints||Two weeks, three months and six months post injury.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. M.I. Renaud|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C. Heugten, van|
|- Sponsor/Initiator ||Maastricht University, Brains Ahead! projectgroep|
(Source(s) of Monetary or Material Support)
|Johanna Kinderfonds, Revalidatiefonds|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||17-apr-2015 - 8-jun-2015|