Determining the Impact of Air Pollution on the Developing Brain
- Conditions
- Attention Deficit Hyperactivity DisorderSocial FunctioningAttentionExecutive Functioning
- Interventions
- Diagnostic Test: Psychological testing and MRI imaging
- Registration Number
- NCT04574414
- Lead Sponsor
- Jagiellonian University
- Brief Summary
* Background: Recent studies have linked exposure to airborne particulate matter (PM) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. We aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution. The investigators aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution.
* Study area: 19 towns in three voivodeships (Lesser Poland, Silesian, Opole) in the southern Poland. To reduce confounding by urbanicity and at the same time, to achieve sufficient contrasts in PM levels without too high logistic costs, towns were selected by size (big and small) and by PM levels (high, medium and low).
* Design: Case-control study with 800 children recruited over two school years, with two population controls per one ADHD case. Suspected cases will be recruited in specialized facilities and presumably ADHD-free children will be recruited in primary schools.
* Exposure assessment: Poland-wide PM and other air pollutants' grids will be created for the years 2006 to 2021 using statistical models to incorporate land use data, estimates from transport models, satellite observations and air pollution measurements from Polish monitoring network. Prenatal, early-life, lifelong and concurrent exposures will be calculated.
* Psychological testing: Every child and their parents will complete a series of psychological tests and interviews that will be conducted during their three visits to the recruitment facility.
* Neuroimaging: Each participant will undergo a Magnetic Resonance Imaging (MRI) scanning session that will be performed accordingly to the Human Connectome Adolescent Brain Cognitive Development project recommendations. Scanning will be performed on a single scanner in Krakow.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
- Attending school in one of the specified towns
- Age 10-13 years (4th-6th grade)
- Native Polish speaker
- Normal or above intelligence
- Standard educational opportunities
- Normal or corrected to normal visual and auditory acuity
- No gross sensory deficit, no gross behavioural problems
- No history of neurological disease
- Autism spectrum disorder (ASD)
- FAS
- FAE
- Intellectual disability
- Metabolic disorders
- Genetic disorders
- Epilepsy
- Cerebral palsy
- Mood disorders
- Tourette Syndrome
- Other illnesses including pharmacotherapy
- Apgar score < 8
- Low birth weight (below 2500 g)
- Preterm birth (below 35th weeks of gestation)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children with Attention Deficit Hyperactivity Disorder Psychological testing and MRI imaging Cases Children without Attention Deficit Hyperactivity Disorder Psychological testing and MRI imaging Population controls
- Primary Outcome Measures
Name Time Method Cognitive functioning October 1, 2020 until December 31, 2022 Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)
Inhibition control October 1, 2020 until December 31, 2022 Go/No Go task will be used as part of MRI measurements.
Attention Deficit Hyperactivity Disorder (ADHD) October 1, 2020 until December 31, 2022 ADHD and comorbidities will be assessed by Conners 3 questionnaire
Attention control October 1, 2020 until December 31, 2022 Attention Network Test (ANT) will be used.
Sustained and selective attention October 1, 2020 until December 31, 2022 Computer Conners Continuous Performance Task (CPT) will be used.
- Secondary Outcome Measures
Name Time Method Full-Scale Intelligence Quotient (IQ) October 1, 2020 until December 31, 2022 IQ will be measured by Stanford-Binet Intelligence Scales, 5th Edition (SB5).
Family functioning October 1, 2020 until December 31, 2022 Polish adaptation of the FACES-IV (Flexibility and Cohesion Evaluation Scales; SOR) will be used to estimate social functioning of the children (family functioning).
Behavioural, emotional, and social problems October 1, 2020 until December 31, 2022 Youth Self-Report Scale (YSR) will be used for this assessment.
Relationships with siblings October 1, 2020 until December 31, 2022 Siblings Relationship Questionnaire (KRR), which is a supplement for the SOR Scale will be used to assess social functioning of the children (relationships with siblings).
Behavioural problems October 1, 2020 until December 31, 2022 Child Behaviour Checklist (CBCL) questionnaire will collect information on the eight syndrome domains: anxious/depressed, depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, aggressive behaviour
Trial Locations
- Locations (1)
Institute of Psychology
🇵🇱Kraków, Poland