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Participation of children and adolescents after mild traumatic brain injury


- candidate number21965
- NTR NumberNTR5153
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-apr-2015
- Secondary IDsMEC-2015-047 METC Erasmus MC
- Public TitleParticipation of children and adolescents after mild traumatic brain injury
- Scientific TitleParticipation of children and adolescents during the first six months post mild traumatic brain injury
- ACRONYMBrains Ahead!
- hypothesisTo 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) studiedTraumatic brain injury, Children, Adolescents
- Inclusion criteriaChildren and adolescents aged 6-18 years.
Diagnosed with mild traumatic brain injuryin one of our participating hospitals in the past week.
- Exclusion criteriaLimited understandig of the Dutch language.
Reoccuring brain injury or central neurological disease during the follow-up period.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-mei-2015
- planned closingdate31-dec-2017
- Target number of participants140
- InterventionsControlgroup 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;
- Psycho-education;
- Follow-up.
- Primary outcomeActivity and participation, measured with the Child and Adolescent Scale of Participation - Dutch Language Version (parentforms).
- Secondary outcomeParticipation 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).
- TimepointsTwo weeks, three months and six months post injury.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. M.I. Renaud
- CONTACT for SCIENTIFIC QUERIESDr. C. Heugten, van
- Sponsor/Initiator Maastricht University, Brains Ahead! projectgroep
- Funding
(Source(s) of Monetary or Material Support)
Johanna Kinderfonds, Revalidatiefonds
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD17-apr-2015 - 8-jun-2015


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