Attention Deficit Hyperactivity Disorder Clinical Trial
— NeuroSmogOfficial title:
NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain
- 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.
Status | Not yet recruiting |
Enrollment | 800 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 13 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Poland | Institute of Psychology | Kraków |
Lead Sponsor | Collaborator |
---|---|
Jagiellonian University | Foundation for Polish Science, Institute of Environmental Protection - National Research Institute (IOS-PIB) |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attention Deficit Hyperactivity Disorder (ADHD) | ADHD and comorbidities will be assessed by Conners 3 questionnaire | October 1, 2020 until December 31, 2022 | |
Primary | Cognitive functioning | Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1) | October 1, 2020 until December 31, 2022 | |
Primary | Attention control | Attention Network Test (ANT) will be used. | October 1, 2020 until December 31, 2022 | |
Primary | Sustained and selective attention | Computer Conners Continuous Performance Task (CPT) will be used. | October 1, 2020 until December 31, 2022 | |
Primary | Inhibition control | Conditioned Approach Response Inhibition Task (CARIT) will be used as part of MRI measurements. | October 1, 2020 until December 31, 2022 | |
Primary | Inhibition control | Go/No Go task will be used as part of MRI measurements. | October 1, 2020 until December 31, 2022 | |
Secondary | Full-Scale Intelligence Quotient (IQ) | IQ will be measured by Stanford-Binet Intelligence Scales, 5th Edition (SB5). | October 1, 2020 until December 31, 2022 | |
Secondary | Family functioning | Polish adaptation of the FACES-IV (Flexibility and Cohesion Evaluation Scales; SOR) will be used to estimate social functioning of the children (family functioning). | October 1, 2020 until December 31, 2022 | |
Secondary | Relationships with siblings | 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). | October 1, 2020 until December 31, 2022 | |
Secondary | Behavioural, emotional, and social problems | Youth Self-Report Scale (YSR) will be used for this assessment. | October 1, 2020 until December 31, 2022 | |
Secondary | Behavioural problems | 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 | October 1, 2020 until December 31, 2022 |
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