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

Sponsor

Walden University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05453708

Collaborator

(none)

180

Enrollment

Location

Anticipated Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Autism Spectrum Disorder Autistic Disorder Pregnancy Related Diet, Healthy Diet; Deficiency Folate Deficiency Folic Acid Deficiency Folic Acid Overdose	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 Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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