N/A
N=426
A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity
Parent-Child Relations · Maternal Behavior · Infant Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04818112 ↗Enrolled (actual)
426
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Mother-Infant Synchrony, Gaze and Affect — 113.89; 106.72; 28.2; 16.1 seconds of synchrony
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ATVV (Behavioral); Attention control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Arizona
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mother-Infant Synchrony, Gaze and Affect |
113.89; 106.72; 28.2; 16.1 | — |
| SECONDARY Mother-Infant Synchrony, Vocalization and Touch |
9.86; 9.76; 16.05; 11.49 | — |
| SECONDARY Oxytocin Receptor Gene DNA Methylation Reflecting Epigenetic Marks |
— | — |
| SECONDARY Oxytocin Receptor Gene Expression |
— | — |
| SECONDARY Oxytocin Receptor Protein |
— | — |
| SECONDARY Oxytocin Peptide, Maternal Plasma |
— | — |
| SECONDARY Oxytocin Peptide, Infant Saliva |
— | — |
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 biologic systems, such as the oxytocin hormone, that can affect attachment behavior. This innovative study has the potential to advance science and improve mother-infant interaction by testing an early life, home-based, multisensory behavioral intervention (called ATVV), targeting the oxytocin system, to promote synchronous early mother-infant interaction, especially critical for mothers who have experienced childhood adversity.
This two-group randomized clinical trial will test the ATVV's effect on oxytocin system function and quality of mother-infant interaction. The investigators will enroll 250 first-time healthy mothers carrying a single baby who have a history of childhood adversity, and obtain baseline data in their third trimester of pregnancy. Soon after birth (before hospital discharge), mothers (and babies) who continue to be eligible are randomized into the intervention group and taught to give ATVV daily for 3 months, or randomized into the Attention Control education group and taught safe infant care. After birth, the investigators check-in frequently with mothers through weekly phone calls. There are 3 study visits at 1, 2 and 3 months after birth that include survey questions and collection of maternal blood and infant saliva. Mothers and babies are also video-recorded at 3 months after birth for 4 minutes to assess mother-infant interaction. The investigators follow-up with a phone call at 6 months after birth.
While both groups will benefit from the content and attention the investigators give mothers, the investigators hypothesize that, compared to the education group, mothers and infants in the intervention group will have improved oxytocin system function and more synchronous mother-infant interaction.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04818112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.