Application form for access to data and biological samples Ref. no

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1 Application form for access to data and biological samples Ref. no Project title: Applicant: Other partners taking part in the project Names and work addresses: Are prenatal maternal stress associated with ADHD-symptoms in children. Name: Lisbeth Lund, stud.cand.scient.san.puble Address: Vestre ringgade 58 3th, 8000 Århus C (flytter d. 1 juli: Gilbjergsgade 2, st. T.V, 2200 Nørrebro.) Carsten Obel, professor, læge, ph.d. Lena Hohwü, postdoc, ph.d., Cand.scient.san Aarhus Universitet, Institut for Folkesundhed Bartholins Allé 2, 8000 Århus C Project description (max 200 words) The description should contain 1) purpose, 2) method, material, data, 3) publishing and 4) up to 5 key words 1. Formål: Formålet med studiet er at undersøge, hvorledes skilsmisse/separation en indikator for stress - under graviditeten kan have indflydelse på udviklingen af ADHD-symptomer hos børn I 11-årsalderen. Sekundært ønskes det belyst, hvorvidt associationens styrke mellem skilsmisse/separation under graviditeten og ADHD-symptomer, afhænger af kvindens selvvurderede stressniveau. 2) Metode og datamateriale: Oplysninger om ADHD-symptomer indhentes fra forældrerapporteret SDQ-score fra 11-års undersøgelsen i BSIG. Oplysninger om skilsmisse/separation indhentes fra BSIG-spørgeskemaet når barnet er 6 måneder. Oplysninger om selvvurderet stress indhentes via spørgeskemaet fra 30. gestationsuge. Oplysninger om potentielle confoundere indhentes via BSIG-spørgeskemaer, herunder selvrapporteret spørgeskema besvaret af moderen i henholdsvis 12. og 30. gestationsuge, når barnet er 6 måneder og 11- år. 3) Publicering: Studiet udføres som et led i et specialeprojekt ved folkesundhedsvidenskab ved Aarhus Universitet. Det forventes, at studiet vil blive publiceret I et internationalt tidsskrift, hvor hovedforfatteren vil være undertegnede. Key words: ADHD, offsprings, pregnancy, prenatal stress, stressful life events, 1

Time schedule: Project start: Data analyses terminated : Final project report: Month _August_15 Year 2015 Month December Year 2015 Month December Year 2015 Please indicate articles planned and their

2 Time schedule: Project start: Data analyses terminated : Final project report: Month _August_15 Year 2015 Month December Year 2015 Month December Year 2015 Please indicate articles planned and their approx title(s): Based on the data applied for, I plan to publish Article no 1, titel: Are divorce/separation during pregnancy associated with ADHD-symptoms among-11-year-old children. Project protocol enclosed: yes no Interview Data Are you applying for interview data? no X yes x Int 1 x Int 2 x Int 3 Int 4 Lifestyle during pregnancy (LDPS) 7-year follow-up x 11-year follow-up Selection criteria: Inklusionskriterierne er følgende: 1) Besvarelse af forældreversionen af SDQ i 11-års undersøgelsen 2) Max ét ubesvaret spørgsmål i SDQ 3) Besvarelse af spørgsmål omhandlende arbejdsrelateret stress ved 12. gestationsuge. Int. 1: A127-A32A_5, A138-A , A184, Specification of data required: (list of variables to be agreed with the DNBC data manager) Int. 2: B074-B079E, B085-B090_1-30, B099A-B099I, B100-B109, B201- B202A Int. 3: P094-P098E, P103-P , C062-C066B.1-4, C067-C069A.3-9, C170-C173, C188-C197, C year-follow-up: F156_1- F156A, F157, F158 2

3 No. of individuals concerned: Ca

4 Biological Specimens Are you applying for biological specimens? Please describe how your study design is adapted to make the best possible use of the biological specimens. Account for the feasibility of the analyses (requirements for transportation, treatment and storages must be taken into consideration). x no yes: from 1st sample quantity from 2nd sample quantity from 3rd sample quantity Only a minimum quantity of blood necessary for the analyses in question will be handed out. Please note that DNA is not yet available from all participants. DNA must be extracted at Statens Serum Institut. Number of persons, selection criteria, time period: For what kind of analyses? (state purpose and method): Where are the laboratory analyses carried out?: References from the laboratory may be enclosed. Supplementary Data Collection Sample analyses results Will you be collecting supplementary data/biological samples from cohort members, or will new analyses data be generated? In you application to the Danish Data Protection Agency (DDPA) remember to state that you will return supplementary data to the DNBC X No Supplementary data and results from biological analyses, including genome-wide scans must be returned to the DNBC database after approval from the DDPA - and be made available for other scientists. If you are contacting DNBC participants by mail, this contact must be initiated by the DNBC secretariat. Which kind of data/biological samples? interview/questionnaire (to be enclosed) 4

5 biological specimens (please specify) How many individuals will be concerned? During which time period will collection take place? Other Approvals Is your project/data collection approved by: Danish Biomedical Research Ethics Committee yes (copy of approval to be enclosed) x no For your information: The DNBC is approved under with the DDPA. Inform the DDPA about this number when you submit your project application to the DDPA. The Danish Data Protection Agency yes (copy of approval to be enclosed) x no (Er under udarbejdelse og jeg vil sende projektnummer og godkendelse så snart jeg har modtaget det) Finances The invoice for the data file should be sent to: Name: Carsten Obel Address: Aarhus Universitet, Institut for Folkesundhed Bartholins Allé Århus C Is the project fully financed? No x Yes, amount:? Name of the funding person/organisations: Aarhus Universitet, Institut for Folkesundhed 5

6 Date and signature Date and signature: D. 21/ Lisbeth Lund Save the application form to your harddisk and mail to together with your protocol and other relevant documentation. 6

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Application form for access to data and biological samples Ref. 2016-02 Project title: Applicant: Other partners taking part in the project Names and work addresses: "Skilsmisse og selvvurderet mentalt