Primary outcomeMean· 84 +/- 7days from birth (approximately 3 months after birth)
Mother-Infant Synchrony, Gaze and Affect
| Group | Value (seconds of synchrony) |
|---|---|
| Behavioral ATVV Intervention | 113.89 |
| Attention Control | 106.72 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataA Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity
NCTNCT04818112 (opens ClinicalTrials.gov in a new tab)Other id2009050756
This trial does not test a peptide that PepBank tracks.
- Measures Oxytocin, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 262 participants (actual)
- Sponsor
- University of Arizona · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- 12 Jul 2021
- Primary completion
- 8 Mar 2024
- Completion
- 17 Jun 2024
- First posted
- 26 Mar 2021
- Last update posted
- 13 Aug 2025
- Conditions
- Parent-Child Relations · Maternal Behavior · Infant Behavior
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20212022202320242025
- N/A
A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity
NCT0481811212 Jul 2021 to 17 Jun 2024
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ATVVBehavioral
- Attention controlBehavioral
Arms2
Experimental
Behavioral ATVV intervention
A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues.
Active comparator
Attention control
An attention control group that receives education on safe infant care and the same amount of attention as the intervention group.
Primary outcomes1
Outcomes the sponsor listed as primary.
Mother-Infant Synchrony, Gaze and Affect
Time frame · 84 +/- 7days from birth (approximately 3 months after birth)
Registry description
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.
Secondary outcomes(6)
Mother-Infant Synchrony, Vocalization and Touch
Time frame · 84 +/- 7days from birth (approximately 3 months after birth)
Registry description
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).
Oxytocin Receptor Gene DNA Methylation Reflecting Epigenetic Marks
Time frame · Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Registry description
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.
Oxytocin Receptor Gene Expression
Time frame · Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Registry description
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.
Oxytocin Receptor Protein
Time frame · Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Registry description
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).
Oxytocin Peptide, Maternal Plasma
Time frame · Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Registry description
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).
Oxytocin Peptide, Infant Saliva
Time frame · Every 28 days +/- 7 days from birth to 3 months
Registry description
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).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· 84 +/- 7days from birth (approximately 3 months after birth)
Mother-Infant Synchrony, Vocalization and Touch
| Group | Value (seconds of synchrony) |
|---|---|
| Behavioral ATVV Intervention | 9.86 |
| Attention Control | 9.76 |
Secondary outcome· Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Oxytocin Receptor Gene DNA Methylation Reflecting Epigenetic Marks
| Group | Value |
|---|
Secondary outcome· Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Oxytocin Receptor Gene Expression
| Group | Value |
|---|
Secondary outcome· Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Oxytocin Receptor Protein
| Group | Value |
|---|
Secondary outcome· Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Oxytocin Peptide, Maternal Plasma
| Group | Value |
|---|
Secondary outcome· Every 28 days +/- 7 days from birth to 3 months
Oxytocin Peptide, Infant Saliva
| Group | Value |
|---|
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Behavioral ATVV Intervention - MothersA 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. | 0 / 105 | 0 / 105 | 0 / 105 |
| Attention Control - MothersAn 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. | 0 / 106 | 0 / 106 | 0 / 106 |
| Behavioral ATVV Intervention - InfantsA 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. | 0 / 105 | 0 / 105 | 0 / 105 |
| Attention Control - InfantsAn 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. | 0 / 106 | 0 / 106 | 0 / 106 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedBell AF, Feldman R, Bedrick EJ, Fisher JM, Carter CS, MacLean EL, Tecot SR, White-Traut R. The efficacy of Massage+ on mother-infant synchrony in mothers with childhood adversity: A randomized controlled trial. Dev Psychol. 2026 Aug 31. doi: 10.1037/dev0002255. Online ahead of print. PMID 42671818
- DerivedJones 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
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Pregnant
2. Healthy (gestational diabetes is acceptable)
3. Greater than or equal to 18 years old
4. Nulliparous (previous miscarriage(s) and/or abortion(s) acceptable)
5. Speak and read English or Spanish
6. Score greater than or equal to 2 on the Adverse Childhood Experience (ACE) survey
7. Expect to deliver a healthy infant
8. Expect to deliver a full-term infant (greater than or equal to 37 weeks and 0/7 days)
9. Expect to deliver a singleton infant
Exclusion Criteria:
1. Multiparous
2. Have no access to a cell phone during the first 3 postnatal months
3. Carrying multiple fetuses
4. Taking anti-depressant(s) during pregnancy
5. Taking illicit drugs
6. Do not speak and read English or Spanish;
7. Under 18 years of age
8. Score less than 2 on the Adverse Childhood Experience (ACE) survey
9. Deliver an infant diagnosed with conditions that could affect normal development or the oxytocin system
1. Pre-term gestation (less than 37 weeks and 0/7 days)
2. Intrauterine growth retardation (IGR)
3. Small for gestational age (SGA)
4. Chromosomal anomaly including
* Down syndrome (trisomy 21)
* Trisomy 13
* trisomy 18
* Klinefelter syndrome
* Turner syndrome
* Triple X syndrome
5. Congenital anomaly including
* Heart defect
* Musculoskeletal defect
* Neural tube defect
* Cystic Fibrosis
* Haemophilia
* Microcephaly
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