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Application form for access to data and biological samples Ref. 2016-20 Project title: Applicant: Other partners taking part in the project Names and work addresses: Developmental trajectories of child mental health - A risk and resilience perspective Name: Rikke Thaarup Wesselhöft, rwesselhoeft@health.sdu.dk, tlf. 22358590 Address: Research Unit of E-Mental Health, Odense University of Southern Denmark Sdr. Boulevard 29 5000 Odense C Argyris Stringaris, Institute of Psychiatry, King s College, London Anne Mette Skovgaard, Institue f Public Health, Copenhagen University Charlotte Ulrikka Rask, Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Ida Skytte Jakobsen, University College Lillebælt Anders Bo Bojesen, statistiker, Centre of E-mental Health, University of Southern Denmark Project description (max 200 words) The description should contain 1) purpose, 2) method, material, data, 3) publishing and 4) up to 5 key words Purpose To describe the continuity of childhood mental health problems, by: 1) Identifying perinatal predictors of childhood psychopathology at age 8-10 years. 2) Examining how life stressors and personal positive attributes at age 8-10 years affects the development of psychopathology at age 11 years. Methods Study participants are a subsample of DNBC children (N=4,500). They have previously participated in a ph.d. study conducted by this applicant (Wesselhoeft et al. accepted for publication in Compr. Psych. 2016). Here, 90 children age 8-10 were identified with depression, 130 with oppositional defiant disorder and 160 with anxiety using the DAWBA. Study 1) The exposure variables are maternal perinatal problems (worries, strains, mental problems etc.). The outcomes are child psychiatric disorders at age 8-10 years (DAWBA) and psychiatric problems at age 8-10/11 years measured by the Strengths and Difficulties Questionnaire (SDQ). Study 2) Baseline measures at age 8-10 are: strengths (DAWBA: YSI, SAS, FQ. SDQ: strengths) and life stressors (DAWBA background). Outcomes at age 11 are: SDQ, well-being and specific items: self harm, psychotic/depressive, OCD etc. Time Schedule Nov. 2016 Dec. 2017: Data analyses Jan. 2018 Dec. 2019: Reporting The results will be reported in a peer-reviewed journal. Key words: Resilience, protective and risk factors, mental health, trajectories 2
Time schedule: Project start: Data analyses terminated : Final project report: Month _Nov Year 2016 Month _Dec Year 2017 Month _Dec Year 2019 Please indicate articles planned and their approx title(s): Based on the data applied for, I plan to publish Article 1: Perinatal maternal problems and their association with childhood psychiatric disorders Article 2: Do child personal attributes at age 8-10 years reduce the risk for mental health problems at age 11 years? Article 3: Do child life stressors at age 8-10 years increase the risk for mental health problems at age 11 years? Project protocol enclosed: yes Project protocol enclosed for Study 2 Interview Data Are you applying for interview data? X yes Int 1 Int 2 Int 3 Int 4 Lifestyle during pregnancy (LDPS) 7-year follow-up 11-year follow-up Selection criteria: Participants included in the ph.d. study of the applicant (N=4,500) (BSIG j.nr. 2014-14) 3
Interview 1: Mental disorders (A075-A078) Medicine (A114-A116) Confounders (e.g. tobacco use (A127-A135), drugs, alcohol, reproductive experience and socio-demographic characteristics etc.) Interview 2: Mental disorders (B201-B205) Worries, strains and feelings (B099-B109) Medicine (B225-B228) Confounders (e.g. tobacco use (B074-B082), drugs, alcohol, reproductive experience and socio-demographic characteristics etc.) Interview 3: Worries, strains and feelings (C178-C197) Neurodevelopmental milestones (C215-C230) Specification of data required: (list of variables to be agreed with the DNBC data manager) Interview 4: Burden (D123-D133) Neurodevelopmental milestones (D134-D147) Child characteristics (D148-151) From the 11-year follow-up (child): SDQ (E103-E108) Social relations, well-being, school achievements (E011-E020) General wellbeing (E021-E029) Health including psychological (E083-E088) Mental health (E112-E117) Eating disorders (E033-E038) Psychotic-like experiences (E117) Family structure (E003-E010) Abuse (alcohol, hash) (E076-E082) From the 11-year follow-up (mother): SDQ (F156-F162) Tics (F163-F165) Illness in the closest family (F178-F182) From the 11-year follow-up (teacher): SDQ No. of individuals concerned: N=4,500 4
Biological Specimens Are you applying for biological specimens? yes: 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). 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 te that DNA is t 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 No Yes Supplementary data and results from biological analyses, including geme-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) 5
linkage with other registries (please specify) DNBC Application Form Register data: Maternal, paternal and offspring psychiatric disorder diagses (the Psychiatric Central Research Register) Confounders e.g. birth complications, parity, socio-ecomic status etc. (the Medical Birth Registry) biological specimens (please specify) How many individuals will be concerned? During which time period will collection take place? 4,500 Other Approvals Is your project/data collection approved by: Danish Biomedical Research Ethics Committee yes (copy of approval to be enclosed) For your information: The DNBC is approved under 2012-54-0268 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) CVR-nr. 11-88-37-29 Finances 6
The invoice for the data file should be sent to: Name: Post Doc Rikke Wesselhöft Address: Telepsykiatrisk Forskningsenhed, Sdr. Boulevard 29, 5000 Odense C Is the project fully financed? No Yes, amount: Name of the funding person/organisations: An application has been sent to Trygfonden March 1 st 2016 and is currently under external review. Response expected September 2016. Date and signature Date and signature: Save the application form to your harddisk and mail to dnbc-research@ssi.dk together with your protocol and other relevant documentation. Please state the applicant s name and date clearly in the protocol. 7