ATVV Intervention for Parent-Child Relationship

Recruiting at 1 trial location

Overseen By Aleeca Bell, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Antidepressants, Illicit drugs

Disqualifiers: Multiparous, No cell phone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 3 months

261 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Aleeca Bell, PhD

Principal Investigator

University of Arizona, College of Nursing

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Behavioral ATVV intervention Experimental Treatment 1 Intervention

A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues.

Group II: Attention control Active Control 1 Intervention

An attention control group that receives education on safe infant care and the same amount of attention as the intervention group.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Children's Wisconsin

Collaborator

Trials

3

Recruited

500+