None listed
Conditions
Brief summary
By age 10, 1 in 5 children (~51,000 Australian children) will sustain a concussion and present with post-concussive symptoms (PCS) requiring medical treatment. Many children and youth recover rapidly from these symptoms and are symptom free and returned to pre-injury activities within 4 weeks. In contrast, ~40% of children suffer ‘persisting PCS’ (PPCS), defined as 2 or more PCS lasting more than 4 weeks. This group of children have limited tolerance for routine academic, sport/leisure and social activities and are unable to return safely to these activities. Despite their debilitating impact, intervention trials addressing PPCS in children are lacking. We propose a randomised trial of a novel multimodal intervention to reduce the burden of debilitating PPCS for the ~40% of children who experience delayed recovery after concussion. Participants with PPCS at 2-3 weeks post-injury will be recruited and randomised to either active (CE) or usual care (UC) interventions, which will be delivered over up to 8 sessions between 4 – 12 weeks post-injury. The primary aim of the CE is to reduce the number and severity of PPCS. We propose the following hypotheses: Hypothesis 1: Compared to the UC, children in the CE will have a clinically significant reduction in number and severity of PPCS by treatment completion Hypothesis 2: Compared to the UC, children in the CE intervention will have a significantly higher proportion of children who, at treatment completion, have: 2.1 Demonstrated reduction in PPCS across all clusters: generic, physical, psychological 2.2 Returned to normal activity (school, sports, leisure activities) 2.3 Improved physical and psychosocial quality of life 2.4 Lower rate of utilisation of health services
Interventions
The intervention group Concussion Essentials (CE) will receive up to 8 weeks (8 scheduled, 1 hour sessions) of an individualised multimodal intervention, provided by trained clinicians. CE incorporates three modules designed to treat symptoms within the key PPCS clusters: common, physical, psychological. For each module, treatment procedures will be clearly detailed and manualised to ensure consistency.
1. Concussion essentials module: Participants will receive education and advice addressing s
The intervention group Concussion Essentials (CE) will receive up to 8 weeks (8 scheduled, 1 hour sessions) of an individualised multimodal intervention, provided by trained clinicians. CE incorporates three modules designed to treat symptoms within the key PPCS clusters: common, physical, psychological. For each module, treatment procedures will be clearly detailed and manualised to ensure consistency. 1. Concussion essentials module: Participants will receive education and advice addressing symptoms commonly experienced by children with PPCS. 2. Physical module: Participants will receive treatment comprising vestibular, ocular-motor and cervical treatment, and supported graded return to aerobic exercise delivered by a clinician under supervision of a neurophysiotherapist experienced in concussion management. 3. Psychological module: Participants will receive evidence-based cognitive behaviour therapy (CBT), the Creating Opportunities for Personal Empowerment (COPE) program, adapted for concussion, and targeting emotional symptoms (anxiety, depression, avoidance), delivered by a clinician or clinical psychology student supervised by an experienced psychologist.
Sponsors
Prof Vicki Anderson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
• Age between 8-18 years (at time of randomisation) • History of concussion up to 10 days prior to ED presentation or referral • Concussion diagnosis will be confirmed by;Evidence of a blow to the head or impulsive force transmitted to the head; One or more of the following: Symptoms • Somatic (e.g., headaches) • Cognitive (e.g., feeling like in a fog) • Emotional symptoms (e.g., lability) Physical signs • Loss of consciousness • Amnesia • Neurological deficit Balance impairment (e.g., gait unsteadiness) Behavioural changes (e.g., irritability) Cognitive impairment (e.g., slowed reaction times) Sleep/wake disturbance (e.g., somnolence, drowsiness) Glasgow Coma Score (GCS) 13-15 PPCS at 2 (+ up to 7 days)weeks’ post-injury PPCS will be defined as endorsement >= 2 PCS on the PCSI, over and above those endorsed pre-injury at the baseline assessment
Exclusion criteria
Patients meeting any of the following criteria will be excluded from the study: Injury related: o Unknown time or mechanism of injury o Non-accidental injury o Head injury secondary to faint/collapse/seizure o Structural brain injury on conventional neuroimaging (CT or MRI) o Multiple trauma o Cervical spine injury (clinical and/or radiological) Pre-existing conditions: o Congenital neuro-ophthalmological or vestibular dysfunction o Central neurological conditions (e.g., stroke, uncontrolled or unmanaged epilepsy, moderate to severe brain injury) o Severe mental health history (e.g., actively suicidal, substance abuse, bipolar or psychotic disorders) Researcher judgement of inability to complete study program: o Complex psychosocial history (e.g., family violence, child protection involvement, etc.) o Pre-existing developmental disorders (not in mainstream school, or in mainstream school with a teaching aide) o Insufficient English to complete study requirements o Inability to attend on-site visits
Outcome results
None listed