Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach

New research suggests that about 1 in 8 children may be diagnosed with an autism spectrum disorder (ASD) in the United States. This could be due to several reasons which remain unknown. This study invites mothers who have given birth to children in the United States to share their experiences with diet and supplementation during pregnancy. The purpose of this study is to understand the role of a mother's diet, social standing, and supplementation with folate or folic acid may have on her child's future development of autism. Comparisons will be made between mothers of children who have a child with an official ASD diagnosis from a clinician to mothers of children without an ASD diagnosis. Findings from this study can be used to help identify risk factors for ASD risk.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Autism Spectrum Disorder; Autistic Disorder; Folate Deficiency; Folic Acid Deficiency; Diet, Healthy; Autism; Diet; Deficiency; Folic Acid Overdose
• Intervention / Treatment: Other: Survey

Detailed Description

Autism spectrum disorders (ASD) are a broad range of conditions characterized by social skills, repetitive behaviors, speech, and nonverbal communication challenges. Current prevalence estimates assert that 2.3% of children aged eight years or older live with an ASD, an increase from 1.5% in 2012. Estimates suggest that 1 in 44 children will be diagnosed with ASD. A child diagnosed on the spectrum faces several challenges and may require support from a caregiver, possibly across the lifespan. ASD etiology remains elusive, but research suggests there may be a link to genetic, environmental, and dietary risk factors while in-utero.

Further evidence suggests a folate/folic acid link during the peri-conceptual period. Prior folate/folic acid studies suggest a U-shaped relationship between maternal multivitamin supplementation. High maternal plasma folate and B12 levels are associated with the risk of ASD.

This study aims to apply a case-control approach to understand the role of folate/folic over- or under-supplementation, maternal sociodemographics, and diet during pregnancy on ASD risk.

• Study Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55401
      • Walden University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This survey asks mothers to provide information about their experiences with diet and supplementation during pregnancy.

Description

Inclusion Criteria:

• Mothers 18 years or older with a child aged 3-12 years who have an official ASD diagnosis from a clinician
• Mothers 18 years or older of children aged 3-12 years who do not have an ASD diagnosis so comparisons can be made between groups

Exclusion Criteria:

• Mothers outside of the United States
• Mothers less than 18 years of age
• Mothers who have not given birth to their child or who used a surrogate

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Autism Risk; Survey for mothers 18 years or older with a child aged 3-12 years who has an official ASD diagnosis from a clinician.	Other: Survey; One 15-20-minute survey
Controls; Survey for mothers 18 years or older of children aged 3-12 years who do not have an ASD diagnosis so comparisons can be made between groups.	Other: Survey; One 15-20-minute survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire.	Number of participants with a child diagnosed with ASD who used multivitamins or folate/folic acid supplements during pregnancy as assessed by the questionnaire.	42 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.	Number of participants with a child diagnosed with ASD who also have a comorbidity or developed a comorbidity during pregnancy as assessed by the questionnaire.	42 weeks gestation

Collaborators and Investigators

• Sponsor: Walden University
• Investigators: Principal Investigator: Michael M Haniff, STUDENT

Publications and helpful links

Helpful Links

• Please visit http://www.autismrisksurvey.com to participate

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): January 22, 2023
• Study Completion (Actual): January 22, 2023

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Diet; Folic Acid; Folate; Perinatal; Maternal diet; Autism pregnancy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Neurodevelopmental Disorders; Vitamin B Deficiency; Disease; Autistic Disorder; Autism Spectrum Disorder; Malnutrition; Child Development Disorders, Pervasive; Folic Acid Deficiency
• Other Study ID Numbers: 06-16-22-0412467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No