ATVV Intervention for Parent-Child Relationship

No longer recruiting at 1 trial location
CF
MM
AB
Overseen ByAleeca Bell, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Arizona
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to strengthen the bond between mothers and their newborns using a multisensory technique called ATVV. This technique involves auditory, tactile, visual, and vestibular (balance-related) stimulation in response to the baby's cues. Researchers hope this approach will enhance the function of the oxytocin system, a hormone linked to bonding, particularly for mothers who have faced challenging childhood experiences. Participants are first-time healthy mothers expecting to deliver a single, full-term, healthy baby and who have experienced childhood adversity. In the trial, one group will receive ATVV training, while the other will receive education on safe infant care. The goal is to determine if ATVV leads to better mother-infant interaction and oxytocin responses compared to the education group. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve maternal and infant well-being.

Will I have to stop taking my current medications?

If you are taking anti-depressants during pregnancy, you will not be eligible to participate in this trial. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.

What prior data suggests that the ATVV intervention is safe for mother-infant interaction?

Research has shown that the ATVV (Auditory, Tactile, Visual, and Vestibular) method is generally safe. Studies have found that this multi-sensory approach can help babies become more alert and may even shorten their hospital stay. Specifically, one study discovered that babies receiving ATVV improved their feeding skills faster and could go home sooner.

Importantly, studies on ATVV have reported no major negative effects. The treatment is considered well-tolerated because it involves natural activities like gentle touch, sounds, and movement. These findings provide confidence that ATVV is a safe option for mothers and their babies participating in this trial.12345

Why are researchers excited about this trial?

The ATVV intervention is unique because it offers a multi-sensory approach to enhancing the parent-child relationship, which is not typical of standard treatments. Unlike traditional methods that might focus solely on behavioral advice or caregiver education, ATVV incorporates auditory, tactile, visual, and vestibular stimulation in response to infant cues. Researchers are excited about this technique because it could lead to more responsive and engaging interactions between parents and infants, potentially improving developmental outcomes in a way that current standard care options do not prioritize.

What evidence suggests that the ATVV intervention is effective for improving mother-infant interaction?

Research has shown that the ATVV (Auditory, Tactile, Visual, and Vestibular) method, which participants in this trial may receive, can enhance mother-baby interactions. Studies have found that ATVV helps preterm babies become more alert and begin regular feeding sooner, supporting their growth. Specifically, one study discovered that ATVV improved development and interaction, allowing preterm babies to leave the hospital sooner. Another study found that combining ATVV with kangaroo care reduced stress for mothers and improved their interactions with their babies. These findings suggest that ATVV might strengthen the bond between mothers and their babies, particularly for those who have faced challenges in their own childhoods. Meanwhile, the attention control group in this trial will receive education on safe infant care and the same amount of attention as the intervention group.12678

Who Is on the Research Team?

AB

Aleeca Bell, PhD

Principal Investigator

University of Arizona, College of Nursing

Are You a Good Fit for This Trial?

This trial is for first-time mothers over 18, expecting a single full-term and healthy baby, who have experienced childhood adversity as indicated by an ACE score of 2 or more. They must speak English or Spanish and not be taking antidepressants or illicit drugs during pregnancy.

Inclusion Criteria

You are pregnant with only one baby.
You are pregnant and expected to have a healthy baby.
You are currently pregnant.
See 5 more

Exclusion Criteria

Have no access to a cell phone during the first 3 postnatal months
You are pregnant with more than one baby.
I cannot speak or read English or Spanish.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline data collection in the third trimester, including OXT measures and demographic data

1 visit
1 visit (in-person)

Treatment

Participants are randomized into either the ATVV intervention group or the Attention Control group, with daily activities for 3 months

3 months
3 visits (in-person) at 1, 2, and 3 months, weekly phone calls

Follow-up

Participants are monitored for the effects of the intervention, including a phone call at 6 months postnatal

3 months
1 phone call at 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Attention control
  • ATVV
Trial Overview The study tests ATVV (a multisensory behavioral intervention) against standard education on safe infant care to see if it improves mother-infant interaction in women with past childhood adversity. Mothers are randomly assigned to one of the two groups and followed up from the third trimester through six months post-birth.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral ATVV interventionExperimental Treatment1 Intervention
Group II: Attention controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+

Children's Wisconsin

Collaborator

Trials
3
Recruited
500+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/11848115/
Effect of auditory, tactile, visual, and vestibular intervention on ...This study determined whether an auditory, tactile, visual, and vestibular intervention (ATVV) reduced the length of hospitalization of 37 preterm infants.
Effect of auditory, tactile, visual, and vestibular intervention ...This study determined whether an auditory, tactile, visual, and vestibular intervention (ATVV) reduced the length of hospitalization of 37 ...
Mother–infant interaction improves with a developmental ...This study examined the effects of the auditory–tactile–visual–vestibular (ATVV) intervention and kangaroo care (KC) on maternal distress and the mother ...
Effect of auditory, tactile, visual, and vestibular intervention ...ATVV intervention facilitated increased alertness, faster transition to complete nipple feeding, and decreased length of hospitalization of 37 preterm ...
Multi-sensory intervention for preterm infants improves ...The ATVV provided 10 minutes of auditory (female voice), tactile (moderate touch stroking or massage) and visual (eye to eye) stimulation, followed by 5 minutes ...
Intervention strategies to enhance early mother-infant ...A three-arm experimental study examined the effects of auditory–tactile–visual–vestibular (ATVV) intervention and kangaroo care (KC) on the maternal-infant ...
Effect of auditory, tactile, visual, and vestibular intervention ...ATVV intervention facilitated increased alertness, faster transition to complete nipple feeding, and decreased length of hospitalization. Discharge criteria for ...
NICU sensory experiences associated with positive ...Effect of auditory, tactile, visual, and vestibular intervention on length of stay, alertness, and feeding progression in preterm infants.
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