Clinical Trials Directory

Trials / Completed

CompletedNCT01599052

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
Phase
Study type
Observational
Enrollment
152 (actual)
Sponsor
University Medical Center Groningen · Academic / Other
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2011-03-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2012-05-15
Last updated
2021-09-01

Locations

4 sites across 2 countries: Belgium, Netherlands

Source: ClinicalTrials.gov record NCT01599052. Inclusion in this directory is not an endorsement.