Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03269110
Registration number
NCT03269110
Ethics application status
Date submitted
10/08/2017
Date registered
31/08/2017
Titles & IDs
Public title
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Query!
Scientific title
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Query!
Secondary ID [1]
0
0
CTO 816
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
0
0
Query!
Asthma
0
0
Query!
Executive Dysfunction
0
0
Query!
Emotional Problem
0
0
Query!
Behavioural Problem
0
0
Query!
Pre-Eclampsia
0
0
Query!
Death
0
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
0
0
0
0
Query!
Fetal medicine and complications of pregnancy
Query!
Cardiovascular
0
0
0
0
Query!
Hypertension
Query!
Mental Health
0
0
0
0
Query!
Autistic spectrum disorders
Query!
Mental Health
0
0
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Diagnosis / Prognosis - SRS 2, CBCL, BRIEF-P
Mother and child(ren) - FACT 4 Child is the post-delivery follow-up of the offspring born to FACT mothers once these children are between the age of 4 - 6 years.
Diagnosis / Prognosis: SRS 2, CBCL, BRIEF-P
This study does not involve an intervention.
Query!
Intervention code [1]
0
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Neurocognitive disability
Query!
Assessment method [1]
0
0
The primary outcome is a competing composite endpoint of neurocognitive disability and death. Neurocognitive disability is a composite outcome related to social impairments, executive function, emotional and behavioural problems which have been associated with Autism Spectrum Disorder (ASD). It will be defined by an abnormal score on any of three standardized and validated assessment tools: SRS-2 BRIEF-P, or CBCL which will be administered to the parents of children aged 4-6 years. Deaths reported between 6 weeks to 4-6 years of age will be recorded as a competing event and treated as part of the primary endpoint.
Query!
Timepoint [1]
0
0
From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Query!
Secondary outcome [1]
0
0
Severe Morbidity
Query!
Assessment method [1]
0
0
Secondary outcomes to be assessed in FACT 4 Child include severe morbidity of FACT offspring, captured by the Mother-Child Health Survey at the age of 4 - 6 years, including incidence of: Severe morbidity defined by any illnesses during the previous years that has necessitated hospitalization or medication/treatment for \>2 months
Query!
Timepoint [1]
0
0
From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Query!
Eligibility
Key inclusion criteria
1. Capability of participant to comprehend and comply with study requirements
2. Mother participated in FACT
Query!
Minimum age
4
Years
Query!
Query!
Maximum age
6
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
1. Confirmed spontaneous termination (miscarriage) or elective termination or stillborn
2. Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/07/2024
Query!
Actual
Query!
Sample size
Target
2578
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Nepean - Penrith
Query!
Recruitment hospital [2]
0
0
Townsville - Douglas
Query!
Recruitment hospital [3]
0
0
Ipswich - Ipswich
Query!
Recruitment hospital [4]
0
0
Women's and Children's Hospital - Adelaide
Query!
Recruitment hospital [5]
0
0
Royal Women's - Parkville
Query!
Recruitment hospital [6]
0
0
Sunshine - St Albans
Query!
Recruitment postcode(s) [1]
0
0
2750 - Penrith
Query!
Recruitment postcode(s) [2]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [3]
0
0
4305 - Ipswich
Query!
Recruitment postcode(s) [4]
0
0
- Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [6]
0
0
3021 - St Albans
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Alberta
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
British Columbia
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Manitoba
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
New Brunswick
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Newfoundland and Labrador
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Ontario
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Quebec
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Saskatchewan
Query!
Country [9]
0
0
Jamaica
Query!
State/province [9]
0
0
Kingston 7
Query!
Country [10]
0
0
Jamaica
Query!
State/province [10]
0
0
Kingston
Query!
Country [11]
0
0
United Kingdom
Query!
State/province [11]
0
0
Cambridgeshire
Query!
Country [12]
0
0
United Kingdom
Query!
State/province [12]
0
0
Cheshire
Query!
Country [13]
0
0
United Kingdom
Query!
State/province [13]
0
0
County Durham
Query!
Country [14]
0
0
United Kingdom
Query!
State/province [14]
0
0
Lancashire
Query!
Country [15]
0
0
United Kingdom
Query!
State/province [15]
0
0
Lincolnshire
Query!
Country [16]
0
0
United Kingdom
Query!
State/province [16]
0
0
Middlesex
Query!
Country [17]
0
0
United Kingdom
Query!
State/province [17]
0
0
Northumberland
Query!
Country [18]
0
0
United Kingdom
Query!
State/province [18]
0
0
Tooting
Query!
Country [19]
0
0
United Kingdom
Query!
State/province [19]
0
0
Tyne And Wear
Query!
Country [20]
0
0
United Kingdom
Query!
State/province [20]
0
0
Blackburn
Query!
Country [21]
0
0
United Kingdom
Query!
State/province [21]
0
0
Burnley
Query!
Country [22]
0
0
United Kingdom
Query!
State/province [22]
0
0
Carlisle
Query!
Country [23]
0
0
United Kingdom
Query!
State/province [23]
0
0
Crumpsall
Query!
Country [24]
0
0
United Kingdom
Query!
State/province [24]
0
0
Durham
Query!
Country [25]
0
0
United Kingdom
Query!
State/province [25]
0
0
London
Query!
Country [26]
0
0
United Kingdom
Query!
State/province [26]
0
0
Middlesbrough
Query!
Country [27]
0
0
United Kingdom
Query!
State/province [27]
0
0
Newcastle upon Tyne
Query!
Country [28]
0
0
United Kingdom
Query!
State/province [28]
0
0
North Shields
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
Norwich
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
Nottingham
Query!
Country [31]
0
0
United Kingdom
Query!
State/province [31]
0
0
Oldham
Query!
Country [32]
0
0
United Kingdom
Query!
State/province [32]
0
0
Stockton
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
Sunderland
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
Uxbridge
Query!
Country [35]
0
0
United Kingdom
Query!
State/province [35]
0
0
Warrington
Query!
Country [36]
0
0
United Kingdom
Query!
State/province [36]
0
0
Whitehaven
Query!
Country [37]
0
0
United Kingdom
Query!
State/province [37]
0
0
Whitley Bay
Query!
Country [38]
0
0
United Kingdom
Query!
State/province [38]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Ottawa Hospital Research Institute
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high dose folic acid supplementation on social impairments associated with Autism Spectrum Disorders (ASDs), and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03269110
Query!
Trial related presentations / publications
Christensen DL, Baio J, Van Naarden Braun K, Bilder D, Charles J, Constantino JN, Daniels J, Durkin MS, Fitzgerald RT, Kurzius-Spencer M, Lee LC, Pettygrove S, Robinson C, Schulz E, Wells C, Wingate MS, Zahorodny W, Yeargin-Allsopp M; Centers for Disease Control and Prevention (CDC). Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years--Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2012. MMWR Surveill Summ. 2016 Apr 1;65(3):1-23. doi: 10.15585/mmwr.ss6503a1. Erratum In: MMWR Morb Mortal Wkly Rep. 2016 Apr 22;65(15):404. doi: 10.15585/mmwr.mm6515a7. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1279. doi: 10.15585/mmwr.mm6745a7. Knapp M, Romeo R, Beecham J. Economic cost of autism in the UK. Autism. 2009 May;13(3):317-36. doi: 10.1177/1362361309104246. Buescher AV, Cidav Z, Knapp M, Mandell DS. Costs of autism spectrum disorders in the United Kingdom and the United States. JAMA Pediatr. 2014 Aug;168(8):721-8. doi: 10.1001/jamapediatrics.2014.210. McQuiston S, Kloczko N. Speech and language development: monitoring process and problems. Pediatr Rev. 2011 Jun;32(6):230-8; quiz 239. doi: 10.1542/pir.32-6-230. No abstract available. Waddell C, McEwan K, Shepherd CA, Offord DR, Hua JM. A public health strategy to improve the mental health of Canadian children. Can J Psychiatry. 2005 Mar;50(4):226-33. doi: 10.1177/070674370505000406. Repchinsky C. CPS 2008: Compendium of Pharmaceuticals and Specialties : The Canadian Drug Reference for Health Professionals. United States: Canadian Pharmacists Association, 2008. ACOG Committee on Practice Bulletins--Obstetrics. ACOG practice bulletin. Diagnosis and management of preeclampsia and eclampsia. Number 33, January 2002. Obstet Gynecol. 2002 Jan;99(1):159-67. doi: 10.1016/s0029-7844(01)01747-1. Oakley GP Jr. Elimination of folic acid-preventable neural tube defects. Am J Prev Med. 2008 Dec;35(6):606-7. doi: 10.1016/j.amepre.2008.09.017. No abstract available. Wilson RD; GENETICS COMMITTEE; MOTHERISK. RETIRED: Pre-conceptional vitamin/folic acid supplementation 2007: the use of folic acid in combination with a multivitamin supplement for the prevention of neural tube defects and other congenital anomalies. J Obstet Gynaecol Can. 2007 Dec;29(12):1003-1013. doi: 10.1016/S1701-2163(16)32685-8. Erratum In: J Obstet Gynaecol Can. 2008 Mar;30(3):193. Goh, Ingrid [corrected to Goh, Y Ingrid]. English, French. Suren P, Roth C, Bresnahan M, Haugen M, Hornig M, Hirtz D, Lie KK, Lipkin WI, Magnus P, Reichborn-Kjennerud T, Schjolberg S, Davey Smith G, Oyen AS, Susser E, Stoltenberg C. Association between maternal use of folic acid supplements and risk of autism spectrum disorders in children. JAMA. 2013 Feb 13;309(6):570-7. doi: 10.1001/jama.2012.155925. Schmidt RJ, Tancredi DJ, Ozonoff S, Hansen RL, Hartiala J, Allayee H, Schmidt LC, Tassone F, Hertz-Picciotto I. Maternal periconceptional folic acid intake and risk of autism spectrum disorders and developmental delay in the CHARGE (CHildhood Autism Risks from Genetics and Environment) case-control study. Am J Clin Nutr. 2012 Jul;96(1):80-9. doi: 10.3945/ajcn.110.004416. Epub 2012 May 30. Schmidt RJ, Hansen RL, Hartiala J, Allayee H, Schmidt LC, Tancredi DJ, Tassone F, Hertz-Picciotto I. Prenatal vitamins, one-carbon metabolism gene variants, and risk for autism. Epidemiology. 2011 Jul;22(4):476-85. doi: 10.1097/EDE.0b013e31821d0e30. Villamor E, Rifas-Shiman SL, Gillman MW, Oken E. Maternal intake of methyl-donor nutrients and child cognition at 3 years of age. Paediatr Perinat Epidemiol. 2012 Jul;26(4):328-35. doi: 10.1111/j.1365-3016.2012.01264.x. Epub 2012 Mar 14. Forns J, Torrent M, Garcia-Esteban R, Caceres A, Pilar Gomila M, Martinez D, Morales E, Julvez J, Grimalt JO, Sunyer J. Longitudinal association between early life socio-environmental factors and attention function at the age 11 years. Environ Res. 2012 Aug;117:54-9. doi: 10.1016/j.envres.2012.04.007. Epub 2012 May 18. Chatzi L, Papadopoulou E, Koutra K, Roumeliotaki T, Georgiou V, Stratakis N, Lebentakou V, Karachaliou M, Vassilaki M, Kogevinas M. Effect of high doses of folic acid supplementation in early pregnancy on child neurodevelopment at 18 months of age: the mother-child cohort 'Rhea' study in Crete, Greece. Public Health Nutr. 2012 Sep;15(9):1728-36. doi: 10.1017/S1368980012000067. Epub 2012 Feb 8. Roth C, Magnus P, Schjolberg S, Stoltenberg C, Suren P, McKeague IW, Davey Smith G, Reichborn-Kjennerud T, Susser E. Folic acid supplements in pregnancy and severe language delay in children. JAMA. 2011 Oct 12;306(14):1566-73. doi: 10.1001/jama.2011.1433. Steenweg-de Graaff J, Roza SJ, Steegers EA, Hofman A, Verhulst FC, Jaddoe VW, Tiemeier H. Maternal folate status in early pregnancy and child emotional and behavioral problems: the Generation R Study. Am J Clin Nutr. 2012 Jun;95(6):1413-21. doi: 10.3945/ajcn.111.030791. Epub 2012 May 9. Roza SJ, van Batenburg-Eddes T, Steegers EA, Jaddoe VW, Mackenbach JP, Hofman A, Verhulst FC, Tiemeier H. Maternal folic acid supplement use in early pregnancy and child behavioural problems: The Generation R Study. Br J Nutr. 2010 Feb;103(3):445-52. doi: 10.1017/S0007114509991954. Epub 2009 Sep 22. Julvez J, Fortuny J, Mendez M, Torrent M, Ribas-Fito N, Sunyer J. Maternal use of folic acid supplements during pregnancy and four-year-old neurodevelopment in a population-based birth cohort. Paediatr Perinat Epidemiol. 2009 May;23(3):199-206. doi: 10.1111/j.1365-3016.2009.01032.x. Epub 2009 Mar 11. Beard CM, Panser LA, Katusic SK. Is excess folic acid supplementation a risk factor for autism? Med Hypotheses. 2011 Jul;77(1):15-7. doi: 10.1016/j.mehy.2011.03.013. Epub 2011 Mar 31. King CR. A novel embryological theory of autism causation involving endogenous biochemicals capable of initiating cellular gene transcription: a possible link between twelve autism risk factors and the autism 'epidemic'. Med Hypotheses. 2011 May;76(5):653-60. doi: 10.1016/j.mehy.2011.01.024. Epub 2011 Mar 8. Salbaum JM, Kappen C. Genetic and epigenomic footprints of folate. Prog Mol Biol Transl Sci. 2012;108:129-58. doi: 10.1016/B978-0-12-398397-8.00006-X. Fenech M. Folate (vitamin B9) and vitamin B12 and their function in the maintenance of nuclear and mitochondrial genome integrity. Mutat Res. 2012 May 1;733(1-2):21-33. doi: 10.1016/j.mrfmmm.2011.11.003. Epub 2011 Nov 7. LaSalle JM. A genomic point-of-view on environmental factors influencing the human brain methylome. Epigenetics. 2011 Jul;6(7):862-9. doi: 10.4161/epi.6.7.16353. Epub 2011 Jul 1. Chang CM, Yu CC, Lu HT, Chou YF, Huang RF. Folate deprivation promotes mitochondrial oxidative decay: DNA large deletions, cytochrome c oxidase dysfunction, membrane depolarization and superoxide overproduction in rat liver. Br J Nutr. 2007 May;97(5):855-63. doi: 10.1017/S0007114507666410. Blaise SA, Alberto JM, Audonnet-Blaise S, Gueant JL, Daval JL. Influence of preconditioning-like hypoxia on the liver of developing methyl-deficient rats. Am J Physiol Endocrinol Metab. 2007 Dec;293(6):E1492-502. doi: 10.1152/ajpendo.00255.2007. Epub 2007 Aug 28. Ferguson SA, Berry KJ, Hansen DK, Wall KS, White G, Antony AC. Behavioral effects of prenatal folate deficiency in mice. Birth Defects Res A Clin Mol Teratol. 2005 Apr;73(4):249-52. doi: 10.1002/bdra.20111. Kerek R, Geoffroy A, Bison A, Martin N, Akchiche N, Pourie G, Helle D, Gueant JL, Bossenmeyer-Pourie C, Daval JL. Early methyl donor deficiency may induce persistent brain defects by reducing Stat3 signaling targeted by miR-124. Cell Death Dis. 2013 Aug 8;4(8):e755. doi: 10.1038/cddis.2013.278. Moretti P, Sahoo T, Hyland K, Bottiglieri T, Peters S, del Gaudio D, Roa B, Curry S, Zhu H, Finnell RH, Neul JL, Ramaekers VT, Blau N, Bacino CA, Miller G, Scaglia F. Cerebral folate deficiency with developmental delay, autism, and response to folinic acid. Neurology. 2005 Mar 22;64(6):1088-90. doi: 10.1212/01.WNL.0000154641.08211.B7. Amir RE, Van den Veyver IB, Wan M, Tran CQ, Francke U, Zoghbi HY. Rett syndrome is caused by mutations in X-linked MECP2, encoding methyl-CpG-binding protein 2. Nat Genet. 1999 Oct;23(2):185-8. doi: 10.1038/13810. Neul JL. The relationship of Rett syndrome and MECP2 disorders to autism. Dialogues Clin Neurosci. 2012 Sep;14(3):253-62. doi: 10.31887/DCNS.2012.14.3/jneul. Padmanabhan N, Jia D, Geary-Joo C, Wu X, Ferguson-Smith AC, Fung E, Bieda MC, Snyder FF, Gravel RA, Cross JC, Watson ED. Mutation in folate metabolism causes epigenetic instability and transgenerational effects on development. Cell. 2013 Sep 26;155(1):81-93. doi: 10.1016/j.cell.2013.09.002. James SJ, Melnyk S, Jernigan S, Pavliv O, Trusty T, Lehman S, Seidel L, Gaylor DW, Cleves MA. A functional polymorphism in the reduced folate carrier gene and DNA hypomethylation in mothers of children with autism. Am J Med Genet B Neuropsychiatr Genet. 2010 Sep;153B(6):1209-20. doi: 10.1002/ajmg.b.31094. Whitrow MJ, Moore VM, Rumbold AR, Davies MJ. Effect of supplemental folic acid in pregnancy on childhood asthma: a prospective birth cohort study. Am J Epidemiol. 2009 Dec 15;170(12):1486-93. doi: 10.1093/aje/kwp315. Epub 2009 Oct 30. Crider KS, Cordero AM, Qi YP, Mulinare J, Dowling NF, Berry RJ. Prenatal folic acid and risk of asthma in children: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Nov;98(5):1272-81. doi: 10.3945/ajcn.113.065623. Epub 2013 Sep 4. Martinussen MP, Risnes KR, Jacobsen GW, Bracken MB. Folic acid supplementation in early pregnancy and asthma in children aged 6 years. Am J Obstet Gynecol. 2012 Jan;206(1):72.e1-7. doi: 10.1016/j.ajog.2011.07.033. Epub 2011 Jul 29. Toriello HV; Policy and Practice Guideline Committee of the American College of Medical Genetics. Policy statement on folic acid and neural tube defects. Genet Med. 2011 Jun;13(6):593-6. doi: 10.1097/GIM.0b013e31821d4188. Keating E, Goncalves P, Campos I, Costa F, Martel F. Folic acid uptake by the human syncytiotrophoblast: interference by pharmacotherapy, drugs of abuse and pathological conditions. Reprod Toxicol. 2009 Dec;28(4):511-20. doi: 10.1016/j.reprotox.2009.07.001. Epub 2009 Jul 16. Cooney CA, Dave AA, Wolff GL. Maternal methyl supplements in mice affect epigenetic variation and DNA methylation of offspring. J Nutr. 2002 Aug;132(8 Suppl):2393S-2400S. doi: 10.1093/jn/132.8.2393S. Waterland RA, Travisano M, Tahiliani KG, Rached MT, Mirza S. Methyl donor supplementation prevents transgenerational amplification of obesity. Int J Obes (Lond). 2008 Sep;32(9):1373-9. doi: 10.1038/ijo.2008.100. Epub 2008 Jul 15. Wolff GL, Kodell RL, Moore SR, Cooney CA. Maternal epigenetics and methyl supplements affect agouti gene expression in Avy/a mice. FASEB J. 1998 Aug;12(11):949-57. Mann JR, McDermott S, Bao H, Hardin J, Gregg A. Pre-eclampsia, birth weight, and autism spectrum disorders. J Autism Dev Disord. 2010 May;40(5):548-54. doi: 10.1007/s10803-009-0903-4. Johnson S, Wolke D. Behavioural outcomes and psychopathology during adolescence. Early Hum Dev. 2013 Apr;89(4):199-207. doi: 10.1016/j.earlhumdev.2013.01.014. Epub 2013 Feb 27. Movsas TZ, Paneth N. The effect of gestational age on symptom severity in children with autism spectrum disorder. J Autism Dev Disord. 2012 Nov;42(11):2431-9. doi: 10.1007/s10803-012-1501-4. Asztalos EV, Murphy KE, Willan AR, Matthews SG, Ohlsson A, Saigal S, Armson BA, Kelly EN, Delisle MF, Gafni A, Lee SK, Sananes R, Rovet J, Guselle P, Amankwah K, Saleem M, Sanchez J; MACS-5 Collaborative Group. Multiple courses of antenatal corticosteroids for preterm birth study: outcomes in children at 5 years of age (MACS-5). JAMA Pediatr. 2013 Dec;167(12):1102-10. doi: 10.1001/jamapediatrics.2013.2764. Constantino JN, Davis SA, Todd RD, Schindler MK, Gross MM, Brophy SL, Metzger LM, Shoushtari CS, Splinter R, Reich W. Validation of a brief quantitative measure of autistic traits: comparison of the social responsiveness scale with the autism diagnostic interview-revised. J Autism Dev Disord. 2003 Aug;33(4):427-33. doi: 10.1023/a:1025014929212. Gioia GA. Isquith PK GP, Kenworthy L. Behavior Rating Inventory of Executive Function (BRIEF). Odessa, Fl: Psychological Assessment Resources, 2000. Achenbach TM, Dumenci, L., & Rescorla, L. A. Ten-Year Comparisons of Problems and Competencies for National Samples of Youth: Self, Parent, and Teacher Reports. Journal of Emotional and Behavioral Disorders 2002;10:194-203. Charman T, Baird G, Simonoff E, Loucas T, Chandler S, Meldrum D, Pickles A. Efficacy of three screening instruments in the identification of autistic-spectrum disorders. Br J Psychiatry. 2007 Dec;191:554-9. doi: 10.1192/bjp.bp.107.040196. Bolte S, Dickhut H, Poustka F. Patterns of parent-reported problems indicative in autism. Psychopathology. 1999 Mar-Apr;32(2):93-7. doi: 10.1159/000029072. Duarte CS, Bordin IA, de Oliveira A, Bird H. The CBCL and the identification of children with autism and related conditions in Brazil: pilot findings. J Autism Dev Disord. 2003 Dec;33(6):703-7. doi: 10.1023/b:jadd.0000006005.31818.1c. Constantino JN, & Gruber, C. P. Social Responsiveness Scale (SRS): Manual. Los Angeles: Western Psychological Services, 2005. Wilkinson LA. A best practice guide to assessment and intervention for autism and Asperger syndrome in schools. London: Jessica Kingsley Publishers, 2010. Bolte S, Poustka F, Constantino JN. Assessing autistic traits: cross-cultural validation of the social responsiveness scale (SRS). Autism Res. 2008 Dec;1(6):354-63. doi: 10.1002/aur.49. Fombonne E, Marcin C, Bruno R, Tinoco CM, Marquez CD. Screening for autism in Mexico. Autism Res. 2012 Jun;5(3):180-9. doi: 10.1002/aur.1235. Epub 2012 May 11. Hsiao MN, Tseng WL, Huang HY, Gau SS. Effects of autistic traits on social and school adjustment in children and adolescents: the moderating roles of age and gender. Res Dev Disabil. 2013 Jan;34(1):254-65. doi: 10.1016/j.ridd.2012.08.001. Epub 2012 Sep 7. Kamio Y, Moriwaki A, Inada N. Utility of teacher-report assessments of autistic severity in Japanese school children. Autism Res Treat. 2013;2013:373240. doi: 10.1155/2013/373240. Epub 2013 Dec 11. Wigham S, McConachie H, Tandos J, Le Couteur AS; Gateshead Millennium Study core team. The reliability and validity of the Social Responsiveness Scale in a UK general child population. Res Dev Disabil. 2012 May-Jun;33(3):944-50. doi: 10.1016/j.ridd.2011.12.017. Epub 2012 Jan 25. Constantino JNGC. Social Responsiveness Scale, Second Edition. Los Angeles: Western Psychological Services, 2012. Anderson P. Assessment and development of executive function (EF) during childhood. Child Neuropsychol. 2002 Jun;8(2):71-82. doi: 10.1076/chin.8.2.71.8724. Gioia GA EK, & Isquith, PK. . Behavior Rating Inventory of Executive Function, Preschool Version. Lutz, Fl: Psychological Assessment Resources, Inc., 2003. Braun JM, Kalkbrenner AE, Calafat AM, Yolton K, Ye X, Dietrich KN, Lanphear BP. Impact of early-life bisphenol A exposure on behavior and executive function in children. Pediatrics. 2011 Nov;128(5):873-82. doi: 10.1542/peds.2011-1335. Epub 2011 Oct 24. Duku E, Vaillancourt T. Validation of the BRIEF-P in a sample of Canadian preschool children. Child Neuropsychol. 2014;20(3):358-71. doi: 10.1080/09297049.2013.796919. Epub 2013 May 31. Egeland J, Fallmyr O. Confirmatory Factor Analysis of the Behavior Rating Inventory of Executive Function (BRIEF): support for a distinction between emotional and behavioral regulation. Child Neuropsychol. 2010;16(4):326-37. doi: 10.1080/09297041003601462. Epub 2010 Mar 5. Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002 Dec;8(4):249-57. doi: 10.1076/chin.8.4.249.13513. Achenbach TM, & Rescorla, L.A. Manual for the ASEBA Preschool forms and Profiles. Burlington, VT: University of Vermont Department of Psychiatry, 2000. Achenbach T. Manual for the Child Behavior Checklist/2-1 and 1992 Profile. Burlington (VT): University of Vermont Department of Psychiatry, 1992. Achenbach TM, & Rescorla, L. A. Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families, 2001. Cai X, Kaiser AP, Hancock TB. Parent and teacher agreement on child behavior checklist items in a sample of preschoolers from low-income and predominantly African American families. J Clin Child Adolesc Psychol. 2004 Jun;33(2):303-12. doi: 10.1207/s15374424jccp3302_12. Pandolfi V, Magyar CI, Dill CA. Confirmatory factor analysis of the child behavior checklist 1.5-5 in a sample of children with autism spectrum disorders. J Autism Dev Disord. 2009 Jul;39(7):986-95. doi: 10.1007/s10803-009-0716-5. Epub 2009 Mar 5. Suglia SF, Duarte CS, Chambers EC, Boynton-Jarrett R. Social and behavioral risk factors for obesity in early childhood. J Dev Behav Pediatr. 2013 Oct;34(8):549-56. doi: 10.1097/DBP.0b013e3182a509c0. Tan TX, Dedrick RF, Marfo K. Factor structure and clinical implications of child behavior checklist/1.5-5 ratings in a sample of girls adopted from China. J Pediatr Psychol. 2007 Aug;32(7):807-18. doi: 10.1093/jpepsy/jsm025. Epub 2007 Apr 19. Austin PC, Lee DS, Fine JP. Introduction to the Analysis of Survival Data in the Presence of Competing Risks. Circulation. 2016 Feb 9;133(6):601-9. doi: 10.1161/CIRCULATIONAHA.115.017719. AP Association. Diagnostic and statistical manual of mental disorders (5th Ed.). Washington, DC.: American Psychiatric Publishing, 2013. Andrews, D. Children With School Problems: A Physician's Manual: The Canadian Paediatric Society, 2012.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Mark Walker, MD
Query!
Address
0
0
The Ottawa Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03269110