The aim of this study is to examine the daily level of activities and participation after LTH in children and adolescents (6-18 years) and to identify possible predictors. In addition, experimental research is done in a subgroup to measure theā¦
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters for both the cohort study and the RCT are (both
parent and youth version of) the Child and Adolescent Scale of Participation -
Dutch Language Version (CASP-DLV) and the Dutch translation of the Children's
Assessment of Participation and Enjoyment (CAPE ). With these questionnaires
the level of daily activity and participation is measured.
Secondary outcome
The following secundary parameters for both the cohort and for the RCT are:
- Pediatric Questionnaire - Quality of Life Scale and the Multidimensional
Fatigue Scale (PedsQL), provides insight into the quality of life and level of
fatigue.
- Sensory Profile - short version (SP-NL) and Adolescent / Adult Sensory
Profile (AASP-NL), provides insight into sensory information processing.
- Health and Behavior Intventory (HBI), provides insight into cognitive,
somatic (eg pain), emotional and behavioral functioning.
- Impact of Event (SVL), provides insight into possible posttraumatic stress
reactions.
- Registration form (RF), herein demographic (eg. age, gender, education) and
injury-related (eg. nature of injury, GCS, PTA duration) are recorded.
Background summary
Traumatic brain injury is the leading cause of acquired brain injury among
children and youth. Approximately 14,000 children and youth under the age of 24
years are diagnosed annually with traumatic brain injury in the Netherlands.
About 80% of this group is diganosed with mild traumatic brain injury (LTH).
This subgroup is not structurally followed by a practitioner, while an
estimated 10-20% of this group still have adverse consequences after six
months. In the Netherlands, this accounts for approximately 1,700 children and
youth each year. Lack of diagnostics, underestimation and a too late
recognition of the often invisible long-term consequences (such as reduced
capacity and cognitive problems), often lead unnecessarily to chronic and
disruptive consequences for youth and family participation, such as problems at
school and in social relations. The consequences are a major expense for the
Dutch society. Early detection of problems in this group and early intervention
could potentially prevent the long-term consequences.
Study objective
The aim of this study is to examine the daily level of activities and
participation after LTH in children and adolescents (6-18 years) and to
identify possible predictors. In addition, experimental research is done in a
subgroup to measure the effect of an early intervention, which contains
monitoring, psycho-education and case management, meant to prevent the
consequences of brain injury on daily activities and participation, compared to
regular care.
Study design
Multicenter prospective longitudinal cohort study with a nested randomized
clinical trial in a subset of participants in the cohort study, in which the
effectiveness of an early intervention compared with usual care is measured.
There will be three measurement points for the participants: within 2 weeks
after injury, three months after injury and six months after injury.
Intervention
The intervention is offered by a rehabilitation professional, with at least HBO
skill level and experience of working with children with aquired brain injury
(eg. A paramedic or nurse). Participants in the RCT assigned to the
intervention group receive the intervention in addition to the usual care.
Participants in the RCT assigned to the control group only receive the usual
care. The intervention consists of 1) monitoring, 2) psyco-education, and 3)
case management.
Study burden and risks
Patients are not at risk. It involves questionnaire administration.
Child/adolescent and his/her parents are (in the private, secure home) assisted
by the researcher during the administration of the questionnaires. It is known
that a part of this population (children and youth with mild traumatic brain
injury) suffers from complaints. It is unknown which of these children are at
risk for complaints and how these complaints can be prevented. This justifies
the conduct of this study.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Children and Youth aged 6-18
- Diagnosed with mild traumatic brain injury (according to criteria ACRM en WHO collaborating centre for neurotrauma, Task Force (Kristman, 2014) in our participating hospitals
Exclusion criteria
- Lack of dutch language
- Recurrent braindamage of central neurological disease during the follow-up period
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL51968.078.14 |