Autism Spectrum DisorderNCT03269110
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
An observational study of Autism Spectrum Disorder and Asthma, run by Ottawa Hospital Research Institute at 58 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Asthma, Executive Dysfunction
- What is being tested?
- SRS 2, CBCL, BRIEF-P
- How many people
- 664 participants
- Where
- 58 sitesin 4 countries
- Study dates
- 1 Jul 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: FACT 4 Child is the post-delivery follow-up of offspring born to FACT mothers once children reach the age of 4 years. Women in FACT and their children, will be invited to participate in FACT 4 Child.
Who may be able to join
- Capability of participant to comprehend and comply with study requirements
- Mother participated in FACT
Who cannot join
- Confirmed spontaneous termination (miscarriage) or elective termination or stillborn
- Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital
Trial locations and contacts
58 sites in 4 countries.
58 sites in 4 countries
United Kingdom31 sites
Wansbeck General Hospital
Ashington, Northumberland, NE63 9JJ
Blackburn
Blackburn, BB2 3HH
Burnley
Burnley, BB10 2PQ
Fairfield
Bury, Lancashire, BL9 7TD
Cumberland Infirmary Carlisle
Carlisle
Leighton
Crewe, Cheshire, CW1 4QJ
North Manchester
Crumpsall, M8 5RB
Darlington Memorial Hospital
Darlington, County Durham, DL3 6HX
North Durham
Durham
Gateshead Queen Elizabeth Hospital
Gateshead, Tyne and Wear, NE9 6SX
Hinchingbrooke
Huntingdon, Cambridgeshire, PE29 6NT
West Middlesex University Hospital
Isleworth, Middlesex, TW7 6AF
Lincolnshire
Lincoln, Lincolnshire, LN2 4AX
St George's Hospital
London, Tooting, SW17 0QT
Guy's and St. Thomas
London
South Tees Hospital
Middlesbrough, TS4 3BW
Newcastle upon Tyne Hospitals
Newcastle upon Tyne, NE1 4LP
North Tyneside General Hospital
North Shields, NE29 8NH
Norfolk & Norwich
Norwich
Nottingham City Hospital
Nottingham, NG5 1PB
Nottingham Queens Medical Centre
Nottingham, NG7 2UH
Oldham
Oldham, OL1 2JH
Rochdale
Rochdale, Lancashire, OL12 0NB
South Tyneside Distrcit Hospital
South Shields, Tyne and Wear, NE34 0PL
North Tees Hospital
Stockton, TS19 9AH
Sunderland Royal Hospital
Sunderland, SR4 7TP
Hillingdon Hospital
Uxbridge, UB8 3NN
Warrington Hospital
Warrington
West Cumberland Hospital
Whitehaven
49 Marine Avenue
Whitley Bay
Royal Wolverhampton - New Cross Hospital
Wolverhampton
Canada18 sites
Calgary Foothills Medical Center
Calgary, Alberta, T2N2T9
Edmonton Lois Hole Hospital for Women
Edmonton, Alberta, T5H 3V9
Fredericton Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, E3B 5N5
Hamilton McMaster University
Hamilton, Ontario, L8S 4K1
Kingston
Kingston, Ontario, K7L 2V7
London
London, Ontario, N6A 5W9
Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
Quebec City (CHUL) Centre Hospitalier Universitaire
Montreal, Quebec, G1V 4G2
Sainte-Justine
Montreal, Quebec, H3T 1C5
St-Mary's Hospital
Montreal, Quebec, H3T 1M5
St-Luc
Montreal, Quebec
The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H 8L6
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9
Regina Qu'Appelle Health Region
Regina, Saskatchewan, S4P 0W5
St-John's Women's Health Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Sunnybrook Health Sciences
Toronto, Ontario, M4N 3M5
St-Paul's Hospital
Vancouver, British Columbia, V6Z 2K5
Winnipeg University of Manitoba
Winnipeg, Manitoba, R3E 3P4
Australia6 sites
Women's and Children's Hospital
Adelaide, South Australia
Townsville
Douglas, Queensland, 4814
Ipswich
Ipswich, Queensland, 4305
Royal Women's
Parkville, Victoria, 3052
Nepean
Penrith, New South Wales, 2750
Sunshine
St Albans, Victoria, 3021
Jamaica3 sites
Jubilee
Kingston
Spanishtown
Kingston
University of West Indies
Kingston
About this study
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.
Read the 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
- Being tested
- SRS 2, CBCL, BRIEF-P
- Keywords
- neurological, autism, ASD, behaviour, folic acid, pre-eclampsia, asthma, executive function
- Medical subject headings
- Autism Spectrum Disorder, Asthma, Mental Disorders, Pre-Eclampsia, Death, Neurologic Manifestations, Autistic Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRS 2, CBCL, BRIEF-PDiagnostic test
This study does not involve an intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: SRS 2, CBCL, BRIEF-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive disability
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.
Measured: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Secondary outcomes (1)
Severe Morbidity
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
Measured: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Walker, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269110
- Sponsor's protocol ID
- CTO 816
- Status last verified
- Apr 2025
- First submitted
- 10 Aug 2017
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27031587Knapp M, Romeo R, Beecham J. Economic cost of autism in the UK. Autism. 2009 May;13(3):317-36. doi: 10.1177/1362361309104246.
PubMed 19369391Buescher 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.
PubMed 24911948McQuiston 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.
PubMed 21632874Waddell 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.
PubMed 15898462Repchinsky 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.
PubMed 16175681Oakley 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.
PubMed 19000851Wilson 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.
PubMed 18053387Suren 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.
PubMed 23403681Schmidt 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.
PubMed 22648721Schmidt 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.
PubMed 21610500Villamor 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.
PubMed 22686384Forns 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.
PubMed 22608140Chatzi 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.
PubMed 22314109
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
- ClinicalTrials.gov ID
- NCT03269110
- Acronym / sponsor ID
- CTO 816
- Conditions
- Autism Spectrum Disorder, Asthma, Executive Dysfunction, Emotional Problem, Behavioural Problem, Pre-Eclampsia
- Keywords
- neurological, autism, ASD, behaviour, folic acid, pre-eclampsia, asthma, executive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother and child(ren) | – | Diagnostic Test: SRS 2, CBCL, BRIEF-PFACT 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- FACT 4 Child is the post-delivery follow-up of offspring born to FACT mothers once children reach the age of 4 years. Women in FACT and their children, will be invited to participate in FACT 4 Child.
Key inclusion criteria (2 listed)
- Capability of participant to comprehend and comply with study requirements
- Mother participated in FACT
Key exclusion criteria (2 listed)
- Confirmed spontaneous termination (miscarriage) or elective termination or stillborn
- Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRS 2, CBCL, BRIEF-PThis study does not involve an intervention. | Diagnostic test | Mother and child(ren) |
Primary outcome
Neurocognitive disability
Time frame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
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.
1 secondary outcome
Severe Morbidity
Time frame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Background: PubMed 27031587Christensen 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.
- Background: PubMed 19369391Knapp M, Romeo R, Beecham J. Economic cost of autism in the UK. Autism. 2009 May;13(3):317-36. doi: 10.1177/1362361309104246.
- Background: PubMed 24911948Buescher 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.
- Background: PubMed 21632874McQuiston 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.
- Background: PubMed 15898462Waddell 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.
- BackgroundRepchinsky C. CPS 2008: Compendium of Pharmaceuticals and Specialties : The Canadian Drug Reference for Health Professionals. United States: Canadian Pharmacists Association, 2008.
- Background: PubMed 16175681ACOG 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.
- Background: PubMed 19000851Oakley 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.
- Background: PubMed 18053387Wilson 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.
- Background: PubMed 23403681Suren 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.
- Background: PubMed 22648721Schmidt 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.
- Background: PubMed 21610500Schmidt 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.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Walker, MD principal investigator
The Ottawa Hospital
58 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Asthma, run by Ottawa Hospital Research Institute at 58 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United Kingdom, Canada, Australia, Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive disability (time frame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269110, which also lists 75 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.