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

NCT05453708 | Completed

• 1 other identifier: 06-16-22-0412467
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Autism Spectrum Disorder; Autistic Disorder; Pregnancy Related; Diet, Healthy; Diet; Deficiency; Folate Deficiency; Folic Acid Deficiency; Folic Acid Overdose

Keywords

Diet; Maternal diet; Autism pregnancy; Perinatal; Folate; Folic Acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.

  42 weeks gestation

Study Arms (2)

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

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

Interventions

Survey OTHER

One 15-20-minute survey

Autism Risk; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walden University: lead

Study Sites (1)

Walden University

Minneapolis, Minnesota, 55401, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Malnutrition; Folic Acid Deficiency

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael M Haniff

  Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: June 16, 2022
• Primary Completion: January 22, 2023
• Study Completion: January 22, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)