Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04818112 · ClinicalTrials.gov registry record · NA
A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity
A NA study, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 262
- Enrollment target
NCT04818112: Completed NA study, sponsored by University of Arizona.
NCT04818112 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 262 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04818112, a NA study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 262 participants
- Enrollment target
Study 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.
Primary Outcome
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 mothe
Interventions
- BEHAVIORAL Attention control
- BEHAVIORAL ATVV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2024-06-17 |
| Phase | NA |
What the finished NCT04818112 record still lists
NCT04818112 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Attention control is the first listed.
NCT04818112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04818112 about?
NCT04818112 is a clinical study titled "A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity". 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 ...
What is the current status of trial NCT04818112?
This trial is currently completed. It is a NA study. The enrollment target is 262 participants. The study started on 2021-07-12. Estimated completion is 2024-06-17.
What interventions are being tested in trial NCT04818112?
The interventions under investigation include: Attention control (BEHAVIORAL), ATVV (BEHAVIORAL).
Who is sponsoring clinical trial NCT04818112?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04818112's enrollment target sits among peer trials
262 397th of 2000 higher than 1,604 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03713268 · 262 participants
Intraoperative OCT Guidance of Intraocular Surgery II
- NCT06074380 · 262 participants · Phase 4
Non Inferiority Trial Investigating Surfactants Administered Via MIST
- NCT06293703 · 262 participants · NA
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
- NCT06780137 · 262 participants · Phase 1
A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI