A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity

NCT04818112 | Completed Results DMC

• 1 other identifier: 2009050756
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Parent-Child Relations; Maternal Behavior; Infant Behavior

Keywords

Oxytocin; DNA methylation; Massage; Mothers; Infant; Adverse childhood experiences; Mother-infant interaction; Maternal behavior; Infant behavior; Receptor, oxytocin; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mother-Infant Synchrony, Gaze and Affect

  Video-recordings of mothers freely interacting with their infant were micro-coded second by second for the number of seconds of mother-infant synchrony over 180 seconds. Behaviors are categorized into mutually exclusive codes. The most robust behavior categories for mothers and infants (individually and in synchrony) are gaze and affect. Maternal gaze consisted of mother's gaze to infant's face, to infant's body, to object or environment, and gaze aversion. Infant gaze consisted of gaze to mother, gaze to object or environment, and gaze aversion. Maternal affect consisted of positive, neutral, and negative affective expression. Infant affect consisted of high positive (laugh, giggle, smile), positive (smile, bright face), negative (sad face, occasional whimper), high negative (cry, strong whining), or neutral.

  84 +/- 7days from birth (approximately 3 months after birth)

Secondary Outcomes (6)

• Mother-Infant Synchrony, Vocalization and Touch

  84 +/- 7days from birth (approximately 3 months after birth)

• Oxytocin Receptor Gene DNA Methylation Reflecting Epigenetic Marks

  Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months

• Oxytocin Receptor Gene Expression

  Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months

• Oxytocin Receptor Protein

  Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months

• Oxytocin Peptide, Maternal Plasma

  Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months

Study Arms (2)

Behavioral ATVV intervention

EXPERIMENTAL

A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues.

Behavioral: ATVV

Attention control

ACTIVE COMPARATOR

An attention control group that receives education on safe infant care and the same amount of attention as the intervention group.

Behavioral: Attention control

Interventions

ATVV BEHAVIORAL

A 15-minute behavioral intervention that mothers administer once daily to their infant for 3 months providing Auditory, Tactile, Visual, and Vestibular (ATVV) stimulation. Multisensory stimuli are presented in gradual progression. Mother-infant engagement is attempted throughout ATVV so that mothers learn to identify, interpret and adapt to their infants cues. ATVV can be given without eye to eye gaze making it appropriate for newborns. ATVV is offered contingent on infant cues to promote self-regulation and withdrawn if any persistent disengagement cues. Mothers are taught how to adapt ATVV as their infant grows. Fidelity to the intervention is checked with weekly phone calls and monthly study visits. Mothers also receive a daily text from REDCap to document an intervention frequency log.

Also known as: multisensory infant massage plus

Behavioral ATVV intervention

Attention control BEHAVIORAL

Mothers in the Attention Control group receive a similar amount of daily texts, weekly phone call and in-person study visit attention as mothers in the ATVV group, but with distinctly different content. Over the first 3 postnatal months, mothers learn safe infant-care that includes content on diapers, infant clothing, blankets, infant care including bathing, sleep positions, sleep habits, holding the baby, safety of infant equipment, breastfeeding, formula, and age appropriate toys.

Attention control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Children's Wisconsin: collaborator

Study Sites (2)

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Related Publications (1)

• Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

  PMID: 37146219 DERIVED

MeSH Terms

Conditions

Infant Behavior

Condition Hierarchy (Ancestors)

Child Behavior; Behavior

Results Point of Contact

• Title: Dr. Aleeca Bell
• Organization: University of Arizona

aleecab@arizona.edu

5206260575

Study Officials

• Aleeca Bell, PhD

  University of Arizona, College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The video coders measuring mother-infant synchrony will be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This randomized clinical trial uses group comparison of an intervention group and an education control group.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: July 12, 2021
• Primary Completion: March 8, 2024
• Study Completion: June 17, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)