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Social Cognition in Children Treated for a Brain Tumour

Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01599052
Enrollment
152
Registered
2012-05-15
Start date
2011-03-31
Completion date
2017-03-31
Last updated
2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms, Cystic Fibrosis, Social Behaviour

Keywords

Social Cognition, Theory of Mind, Emotion Recognition, Social competence, Brain Tumour

Brief summary

There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The aim is to study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. If we can identify the specific deficits these patients experience, neuropsychological treatment and guidance can be developed to give patients the most optimal chances to live as normal as possible, to improve their quality of life (QoL) and to prevent them from developing depression and anxiety. Eventually, an intervention programme could be developed based on our results, to improve social, vocational and emotional QoL.

Detailed description

* Rationale: There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The following is expected: 1. Children treated for a BT will perform worse than both healthy controls and patients with Cystic Fibrosis (CF) on measures of social cognition at Time 2 (3 years post diagnosis), but not at Time 1 (shortly after diagnosis, before neurotoxic treatment). The deterioration in performance will be influenced by the following adverse factors: 1. History of cranial radiation therapy; 2. Site of lesion in diencephalon; 3. History of hydrocephalus and/or posterior fossa syndrome; 4. Younger age at diagnosis. 2. Parents and teachers will rate patients with a BT as being less socially competent and experiencing more internalizing problems than healthy controls and patients with CF at Time 2, but not at Time 1. 3. Performance on tests of social cognition will be positively related to executive functions at Time 1 and 2. 4. Performance on tests of social cognition will be positively related to parent and teacher reports of social competence and environmental biographic factors (parental education and occupation) at Time 1 and 2. * Objective: To study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. The focus will be on the neurocognitive basis of such deficits. * Study design: Comparative Non-randomised Prospective International Multi-Centre Study * Study population: 49 Children treated for a BT aged 5-13 years, 32 children diagnosed with CF aged 5-13 years and 32 healthy controls aged 5-13 years.

Interventions

None listed

Sponsors

Radboud University Medical Center
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
Amsterdam UMC, location VUmc
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 5-13 years at first assessment (All groups) * Newly diagnosed brain tumour patients that have not yet received adjuvant therapy (BT patients only) * Stable medical condition (BT and CF patients only)

Exclusion criteria

* Diagnosed with a disorder of the autistic spectrum (Autism, Asperger's Syndrome or Pervasive Developmental Disorder not otherwise specified - All groups) that does not seem to be related to the tumour (BT patients only). * History of other brain disease or neurological condition interfering with normal development (All groups). * No native Dutch speaker (All groups) * Severe sensory handicaps and/or behavioural problems interfering with reliable neuropsychological assessment (All groups) * IQ below 70 (All groups) * Poor prognosis and life expectancy less than 1 year (BT patients only)

Design outcomes

Primary

MeasureTime frameDescription
Social cognitive performancebaseline and 3 years laterChange in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).

Secondary

MeasureTime frameDescription
Social-emotional competencebaseline and 3 years laterParent and Teacher reports of social and emotional functioning from time 1 (diagnosis) to time 2 (3 years later).
Influence of Biographical/Medical characteristicsup to 3 years laterThe influence of individual biographical and medical characteristics (age at diagnosis, histology, sex, tumor site, treatment) on change in performance on tests of social cognition from time 1 to time 2.

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026