Status:
COMPLETED
A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Children's Wisconsin
Conditions:
Parent-Child Relations
Maternal Behavior
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Childhood adversity affects almost two-thirds of the US population, is a major risk factor for the leading causes of disease and increases US economic health burdens. Childhood adversity also alters b...
Detailed Description
Childhood adversity (e.g., abuse, neglect, or household dysfunction), is a common experience significantly contributing to the leading causes of death and increased US economic health burdens. Childho...
Eligibility Criteria
Inclusion
- Pregnant
- Healthy (gestational diabetes is acceptable)
- Greater than or equal to 18 years old
- Nulliparous (previous miscarriage(s) and/or abortion(s) acceptable)
- Speak and read English or Spanish
- Score greater than or equal to 2 on the Adverse Childhood Experience (ACE) survey
- Expect to deliver a healthy infant
- Expect to deliver a full-term infant (greater than or equal to 37 weeks and 0/7 days)
- Expect to deliver a singleton infant
Exclusion
- Multiparous
- Have no access to a cell phone during the first 3 postnatal months
- Carrying multiple fetuses
- Taking anti-depressant(s) during pregnancy
- Taking illicit drugs
- Do not speak and read English or Spanish;
- Under 18 years of age
- Score less than 2 on the Adverse Childhood Experience (ACE) survey
- Deliver an infant diagnosed with conditions that could affect normal development or the oxytocin system
- Pre-term gestation (less than 37 weeks and 0/7 days)
- Intrauterine growth retardation (IGR)
- Small for gestational age (SGA)
- Chromosomal anomaly including
- Down syndrome (trisomy 21)
- Trisomy 13
- trisomy 18
- Klinefelter syndrome
- Turner syndrome
- Triple X syndrome
- Congenital anomaly including
- Heart defect
- Musculoskeletal defect
- Neural tube defect
- Cystic Fibrosis
- Haemophilia
- Microcephaly
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04818112
Start Date
July 12 2021
End Date
June 17 2024
Last Update
August 13 2025
Active Locations (2)
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1
Tucson Medical Center
Tucson, Arizona, United States, 85712
2
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719