Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)

NCT ID: NCT03269110

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 664 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2023-12-31

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.

Detailed Description

The Folic Acid Clinical Trial (FACT) was developed to conclusively determine the effect of high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a randomized controlled trial (RCT) design.

The primary objective of the FACT 4 Child study is to examine the effect of maternal folic acid supplementation in pregnancy on the risk of social impairments, as well as executive function, emotional and behavioural problems associated with Autism Spectrum Disorders (ASD) and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to the CIHR funded FACT.

The effect of folic acid supplementation throughout pregnancy may potentially have an impact on both the mother and her offspring, which highlights the importance and relevance of this study to the management of women with preeclampsia. Results of this study will allow care providers to have the evidence of potential effects of high dose folic acid that can then be discussed; allowing women to make an informed choice about their management and care.

Conditions

Autism Spectrum Disorder; Asthma; Executive Dysfunction; Emotional Problem; Behavioural Problem; Pre-Eclampsia; Death

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

SRS 2, CBCL, BRIEF-P

Intervention Type: DIAGNOSTIC_TEST

This study does not involve an intervention.

Interventions

SRS 2, CBCL, BRIEF-P

This study does not involve an intervention.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Capability of participant to comprehend and comply with study requirements

2. Mother participated in FACT

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Walker, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

Nepean

Penrith, New South Wales, Australia

Townsville

Douglas, Queensland, Australia

Ipswich

Ipswich, Queensland, Australia

Women's and Children's Hospital

Adelaide, South Australia, Australia

Royal Women's

Parkville, Victoria, Australia

Sunshine

St Albans, Victoria, Australia

Calgary Foothills Medical Center

Calgary, Alberta, Canada

Edmonton Lois Hole Hospital for Women

Edmonton, Alberta, Canada

St-Paul's Hospital

Vancouver, British Columbia, Canada

Winnipeg University of Manitoba

Winnipeg, Manitoba, Canada

Fredericton Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, Canada

Moncton Hospital

Moncton, New Brunswick, Canada

St-John's Women's Health Centre

St. John's, Newfoundland and Labrador, Canada

Hamilton McMaster University

Hamilton, Ontario, Canada

Kingston

Kingston, Ontario, Canada

London

London, Ontario, Canada

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, Canada

Sunnybrook Health Sciences

Toronto, Ontario, Canada

Quebec City (CHUL) Centre Hospitalier Universitaire

Montreal, Quebec, Canada

Sainte-Justine

Montreal, Quebec, Canada

St-Mary's Hospital

Montreal, Quebec, Canada

St-Luc

Montreal, Quebec, Canada

Regina Qu'Appelle Health Region

Regina, Saskatchewan, Canada

Jubilee

Kingston, , Jamaica

Spanishtown

Kingston, , Jamaica

University of West Indies

Kingston, , Jamaica

Hinchingbrooke

Huntingdon, Cambridgeshire, United Kingdom

Leighton

Crewe, Cheshire, United Kingdom

Darlington Memorial Hospital

Darlington, County Durham, United Kingdom

Fairfield

Bury, Lancashire, United Kingdom

Rochdale

Rochdale, Lancashire, United Kingdom

Lincolnshire

Lincoln, Lincolnshire, United Kingdom

West Middlesex University Hospital

Isleworth, Middlesex, United Kingdom

Wansbeck General Hospital

Ashington, Northumberland, United Kingdom

St George's Hospital

London, Tooting, United Kingdom

Gateshead Queen Elizabeth Hospital

Gateshead, Tyne and Wear, United Kingdom

South Tyneside Distrcit Hospital

South Shields, Tyne and Wear, United Kingdom

Blackburn

Blackburn, , United Kingdom

Burnley

Burnley, , United Kingdom

Cumberland Infirmary Carlisle

Carlisle, , United Kingdom

North Manchester

Crumpsall, , United Kingdom

North Durham

Durham, , United Kingdom

Guy's and St. Thomas

London, , United Kingdom

South Tees Hospital

Middlesbrough, , United Kingdom

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, , United Kingdom

North Tyneside General Hospital

North Shields, , United Kingdom

Norfolk & Norwich

Norwich, , United Kingdom

Nottingham City Hospital

Nottingham, , United Kingdom

Nottingham Queens Medical Centre

Nottingham, , United Kingdom

Oldham

Oldham, , United Kingdom

North Tees Hospital

Stockton, , United Kingdom

Sunderland Royal Hospital

Sunderland, , United Kingdom

Hillingdon Hospital

Uxbridge, , United Kingdom

Warrington Hospital

Warrington, , United Kingdom

West Cumberland Hospital

Whitehaven, , United Kingdom

49 Marine Avenue

Whitley Bay, , United Kingdom

Royal Wolverhampton - New Cross Hospital

Wolverhampton, , United Kingdom

Countries

Australia; Canada; Jamaica; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 27031587 (View on PubMed)

Knapp M, Romeo R, Beecham J. Economic cost of autism in the UK. Autism. 2009 May;13(3):317-36. doi: 10.1177/1362361309104246.

Reference Type: BACKGROUND

PMID: 19369391 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24911948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21632874 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15898462 (View on PubMed)

Repchinsky C. CPS 2008: Compendium of Pharmaceuticals and Specialties : The Canadian Drug Reference for Health Professionals. United States: Canadian Pharmacists Association, 2008.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 16175681 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19000851 (View on PubMed)

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. English, French.

Reference Type: BACKGROUND

PMID: 18053387 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23403681 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22648721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21610500 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22686384 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22608140 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22314109 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21990300 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22572645 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19772683 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19775381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21454018 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21388746 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22656376 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22093367 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21617367 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17381984 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17726145 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15744731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23928694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15781839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10508514 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23226951 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24074862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20468076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19880541 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24004895 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21982024 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21552133 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19616087 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12163699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18626486 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9707167 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19936906 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23455605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22422339 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24126948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12959421 (View on PubMed)

Gioia GA. Isquith PK GP, Kenworthy L. Behavior Rating Inventory of Executive Function (BRIEF). Odessa, Fl: Psychological Assessment Resources, 2000.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18055961 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10026453 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14714937 (View on PubMed)

Constantino JN, & Gruber, C. P. Social Responsiveness Scale (SRS): Manual. Los Angeles: Western Psychological Services, 2005.

Reference Type: BACKGROUND

Wilkinson LA. A best practice guide to assessment and intervention for autism and Asperger syndrome in schools. London: Jessica Kingsley Publishers, 2010.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19360690 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22581514 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22960068 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24392224 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22277583 (View on PubMed)

Constantino JNGC. Social Responsiveness Scale, Second Edition. Los Angeles: Western Psychological Services, 2012.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12638061 (View on PubMed)

Gioia GA EK, & Isquith, PK. . Behavior Rating Inventory of Executive Function, Preschool Version. Lutz, Fl: Psychological Assessment Resources, Inc., 2003.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 22025598 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23721091 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20209415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12759822 (View on PubMed)

Achenbach TM, & Rescorla, L.A. Manual for the ASEBA Preschool forms and Profiles. Burlington, VT: University of Vermont Department of Psychiatry, 2000.

Reference Type: BACKGROUND

Achenbach T. Manual for the Child Behavior Checklist/2-1 and 1992 Profile. Burlington (VT): University of Vermont Department of Psychiatry, 1992.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 15136195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19263208 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24131877 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17449465 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26858290 (View on PubMed)

AP Association. Diagnostic and statistical manual of mental disorders (5th Ed.). Washington, DC.: American Psychiatric Publishing, 2013.

Reference Type: BACKGROUND

Andrews, D. Children With School Problems: A Physician's Manual: The Canadian Paediatric Society, 2012.

Reference Type: BACKGROUND

Other Identifiers

CTO 816

Identifier Type: -

Identifier Source: org_study_id