Trial Outcomes & Findings for A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity (NCT NCT04818112)

Last Updated: 2025-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

262 participants

Primary outcome timeframe

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

Results posted on

2025-08-13

Participant Flow

Participants (pregnant women) were consented prior to birth. The 262 consented pregnant women are the protocol enrollment number. Between consent and randomization, participants attended a baseline study visit and gave birth. During this period, 49 pregnant women or mother-infant dyads were excluded due to lost to follow-up, no longer meeting inclusion criteria, or withdrawal. Randomization reflects mother-infant dyads at birth: 107 dyads in the intervention, 106 dyads in the control.

Participant milestones

Participant milestones
Measure	Behavioral ATVV Intervention A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues. 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 ATVV is offered contingent on infant cues to promote self-regulation and withdrawn if any persistent disengagement cues.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.	Attention Control An attention control group that receives education on safe infant care and the same amount of attention as the intervention group. 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.
Overall Study STARTED	214	212
Overall Study COMPLETED	122	190
Overall Study NOT COMPLETED	92	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Behavioral ATVV Intervention A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues. 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.	Attention Control An attention control group that receives education on safe infant care and the same amount of attention as the intervention group. 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.
Overall Study Withdrawal by Subject	54	12
Overall Study Lost to Follow-up	38	10

Baseline Characteristics

Participants included both mothers and infants.

Baseline characteristics by cohort

PRIMARY outcome

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

Population: This is the number of subjects at 3 months postpartum with video recordings to measure mother-infant synchrony. 64 dyads in the behavioral ATVV intervention were analyzed, and 98 dyads in the Attention Control were analyzed.

Outcome measures

Outcome measures
Measure	Behavioral ATVV Intervention n=128 Participants A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues. 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.	Attention Control n=196 Participants An attention control group that receives education on safe infant care and the same amount of attention as the intervention group. 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.
Mother-Infant Synchrony, Gaze and Affect Gaze	113.89 seconds of synchrony Interval 103.58 to 124.2	106.72 seconds of synchrony Interval 98.39 to 115.05
Mother-Infant Synchrony, Gaze and Affect Affect	28.2 seconds of synchrony Interval 23.03 to 33.38	16.1 seconds of synchrony Interval 11.92 to 20.29

SECONDARY outcome

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

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 second most robust behavior categories for mothers and infants (individually and in synchrony) are vocalization and touch. Maternal vocalization consisted of motherese positive speech (infant-directed speech typically high-pitched with a sing-song rhythm), adult speech to the infant in a normal range and regular rhythm, adult speech to other adult, and no speech. Infant vocalization consisted of positive (babbling, cooing, or giggles) and negative (fussing or crying).

Outcome measures

Outcome measures
Measure	Behavioral ATVV Intervention n=128 Participants A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues. 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.	Attention Control n=196 Participants An attention control group that receives education on safe infant care and the same amount of attention as the intervention group. 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.
Mother-Infant Synchrony, Vocalization and Touch Vocalization	9.86 seconds of synchrony Interval 7.28 to 12.44	9.76 seconds of synchrony Interval 7.65 to 11.87
Mother-Infant Synchrony, Vocalization and Touch Touch	16.05 seconds of synchrony Interval 12.62 to 19.47	11.49 seconds of synchrony Interval 8.72 to 14.26

SECONDARY outcome

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

Using maternal plasma, % OXTR DNA methylation will be measured at candidate cytosine-phosphate-guanosine (CpG) sites -1001, -959, -934, -924, -901, and -860 that were selected based on their implication in previous studies relating to psychosocial behaviors. There is also cost-effectiveness in using the selected assay to co-target additional CpG regions implicated in the literature relating to psychosocial behaviors. Methylation is measured using bisulfite conversion (EZ DNA Lightning Kit), followed by high-throughput next-generation sequencing of polymerase chain reaction (PCR) amplicons (Illumina MiSeq) at the University of Arizona Genetics Core.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Using maternal plasma, OXTR mRNA level will be measured using quantitative Real-Time PCR (qRT-PCR) that demonstrates total OXTR gene expression. This reflects the DNA transcribed (copied) into RNA before translation produces protein. Analysis is performed by the College of Nursing Biological Core Laboratory.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Using maternal plasma, total protein expression of OXTR will be measured to reflect the amount of OXT receptors available to bind with OXT peptides. Analysis is performed by the College of Nursing Biological Core Laboratory using Anti-OXTR antibody and Western Blot (considered to be the gold standard).

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Using maternal plasma, the ELISA assay will be used to report OXT peptide level. Samples are analyzed at the University of Arizona Laboratory for the Evolutionary Endocrinology of Primates (LEEP) in duplicate by enzyme immunoassay (EIA) using the Oxytocin ELISA kit (Enzo; ADI-901-153A-0001).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 28 days +/- 7 days from birth to 3 months

Using infant saliva, the ELISA assay will be used to report OXT peptide level. Samples are analyzed at the University of Arizona Laboratory for the Evolutionary Endocrinology of Primates (LEEP) in duplicate by enzyme immunoassay (EIA) using the Oxytocin ELISA kit (Enzo; ADI-901-153A-0001).

Outcome measures

Outcome data not reported

Adverse Events

Behavioral ATVV Intervention - Mothers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control - Mothers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral ATVV Intervention - Infants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control - Infants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Aleeca Bell

University of Arizona

Phone: 5206260575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Behavioral ATVV Intervention n=210 Participants A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues. 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.	Attention Control n=212 Participants An attention control group that receives education on safe infant care and the same amount of attention as the intervention group. 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.	Total n=422 Participants Total of all reporting groups
Age, Categorical Mothers · <=18 years	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Age, Categorical Mothers · Between 18 and 65 years	105 Participants n=105 Participants • Participants included both mothers and infants.	106 Participants n=106 Participants • Participants included both mothers and infants.	211 Participants n=211 Participants • Participants included both mothers and infants.
Age, Categorical Mothers · >=65 years	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Age, Categorical Infants (perinates) · <=18 years	105 Participants n=105 Participants • Participants included both mothers and infants.	106 Participants n=106 Participants • Participants included both mothers and infants.	211 Participants n=211 Participants • Participants included both mothers and infants.
Age, Categorical Infants (perinates) · Between 18 and 65 years	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Age, Categorical Infants (perinates) · >=65 years	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Sex: Female, Male Mothers · Female	105 Participants n=105 Participants • Participants included both mothers and infants.	106 Participants n=106 Participants • Participants included both mothers and infants.	211 Participants n=211 Participants • Participants included both mothers and infants.
Sex: Female, Male Mothers · Male	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Sex: Female, Male Infants (perinates) · Female	53 Participants n=105 Participants • Participants included both mothers and infants.	47 Participants n=106 Participants • Participants included both mothers and infants.	100 Participants n=211 Participants • Participants included both mothers and infants.
Sex: Female, Male Infants (perinates) · Male	52 Participants n=105 Participants • Participants included both mothers and infants.	59 Participants n=106 Participants • Participants included both mothers and infants.	111 Participants n=211 Participants • Participants included both mothers and infants.
Ethnicity (NIH/OMB) Mothers · Hispanic or Latino	50 Participants n=105 Participants • Participants included both mothers and infants.	53 Participants n=106 Participants • Participants included both mothers and infants.	103 Participants n=211 Participants • Participants included both mothers and infants.
Ethnicity (NIH/OMB) Mothers · Not Hispanic or Latino	55 Participants n=105 Participants • Participants included both mothers and infants.	53 Participants n=106 Participants • Participants included both mothers and infants.	108 Participants n=211 Participants • Participants included both mothers and infants.
Ethnicity (NIH/OMB) Mothers · Unknown or Not Reported	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Ethnicity (NIH/OMB) Infants · Hispanic or Latino	50 Participants n=105 Participants • Participants included both mothers and infants.	53 Participants n=106 Participants • Participants included both mothers and infants.	103 Participants n=211 Participants • Participants included both mothers and infants.
Ethnicity (NIH/OMB) Infants · Not Hispanic or Latino	55 Participants n=105 Participants • Participants included both mothers and infants.	53 Participants n=106 Participants • Participants included both mothers and infants.	108 Participants n=211 Participants • Participants included both mothers and infants.
Ethnicity (NIH/OMB) Infants · Unknown or Not Reported	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Mothers · American Indian or Alaska Native	1 Participants n=105 Participants • Participants included both mothers and infants.	3 Participants n=106 Participants • Participants included both mothers and infants.	4 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Mothers · Asian	4 Participants n=105 Participants • Participants included both mothers and infants.	5 Participants n=106 Participants • Participants included both mothers and infants.	9 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Mothers · Native Hawaiian or Other Pacific Islander	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Mothers · Black or African American	4 Participants n=105 Participants • Participants included both mothers and infants.	3 Participants n=106 Participants • Participants included both mothers and infants.	7 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Mothers · White	67 Participants n=105 Participants • Participants included both mothers and infants.	74 Participants n=106 Participants • Participants included both mothers and infants.	141 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Mothers · More than one race	4 Participants n=105 Participants • Participants included both mothers and infants.	6 Participants n=106 Participants • Participants included both mothers and infants.	10 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Mothers · Unknown or Not Reported	25 Participants n=105 Participants • Participants included both mothers and infants.	15 Participants n=106 Participants • Participants included both mothers and infants.	40 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Infants · American Indian or Alaska Native	1 Participants n=105 Participants • Participants included both mothers and infants.	3 Participants n=106 Participants • Participants included both mothers and infants.	4 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Infants · Asian	4 Participants n=105 Participants • Participants included both mothers and infants.	5 Participants n=106 Participants • Participants included both mothers and infants.	9 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Infants · Native Hawaiian or Other Pacific Islander	0 Participants n=105 Participants • Participants included both mothers and infants.	0 Participants n=106 Participants • Participants included both mothers and infants.	0 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Infants · Black or African American	4 Participants n=105 Participants • Participants included both mothers and infants.	3 Participants n=106 Participants • Participants included both mothers and infants.	7 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Infants · White	67 Participants n=105 Participants • Participants included both mothers and infants.	74 Participants n=106 Participants • Participants included both mothers and infants.	141 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Infants · More than one race	4 Participants n=105 Participants • Participants included both mothers and infants.	6 Participants n=106 Participants • Participants included both mothers and infants.	10 Participants n=211 Participants • Participants included both mothers and infants.
Race (NIH/OMB) Infants · Unknown or Not Reported	25 Participants n=105 Participants • Participants included both mothers and infants.	15 Participants n=106 Participants • Participants included both mothers and infants.	40 Participants n=211 Participants • Participants included both mothers and infants.