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

NACompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

July 12, 2021

Primary Completion Date

March 8, 2024

Study Completion Date

June 17, 2024

Conditions
Parent-Child RelationsMaternal BehaviorInfant Behavior
Interventions
BEHAVIORAL

ATVV

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 ATVV is offered contingent on infant cues to promote self-regulation and withdrawn if any persistent disengagement cues.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.

BEHAVIORAL

Attention control

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.

Trial Locations (2)

85712

Tucson Medical Center, Tucson

85719

Banner University Medical Center - Tucson, Tucson

All Listed Sponsors
collaborator

Children's Wisconsin

UNKNOWN

lead

University of Arizona

OTHER