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

Completed

• Conditions: Pregnancy Related; Autism Spectrum Disorder; Diet; Deficiency; Folic Acid Deficiency; Diet, Healthy; Folic Acid Overdose; Folate Deficiency; Autism; Autistic Disorder
• Interventions: Other: Survey

• Registration Number: NCT05453708
• Lead Sponsor: Walden University

Brief Summary

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.

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 Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-12
• Primary Completion: 2023-01-22
• Study Completion: 2023-01-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Survey	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.
Autism Risk	Survey	Survey for mothers 18 years or older with a child aged 3-12 years who has an official ASD diagnosis from a clinician.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.	42 weeks gestation	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.

Trial Locations

Locations (1)

Walden University; 🇺🇸 Minneapolis, Minnesota, United States