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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 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 262 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04818112
The ClinicalTrials.gov registry entry for NCT04818112 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Attention control is the first listed.
NCT04818112 reports 0 study locations.
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.
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