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临床试验/NCT04818112
NCT04818112已完成不适用

A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity

University of Arizona2 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2021年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
262
试验地点
2
主要终点
Mother-Infant Synchrony, Gaze and Affect

研究概览

简要总结

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.

详细描述

Childhood adversity (e.g., abuse, neglect, or household dysfunction), is a common experience significantly contributing to the leading causes of death and increased US economic health burdens. Childhood adversity causes long-term alterations on the nervous, endocrine, and immune systems well into adulthood, including dampening of the neuropeptide oxytocin (OXT). A healthy OXT system facilitates responsive social engagement and promotes maternal-infant (M-I) synchrony (reciprocal gaze, affect speech, and touch). Optimal M-I synchrony fuels early brain development and prevents low empathy, disruptive behavior, poor social adaptation, cognitive deficits, and psychopathology in children. The investigators posit that mothers with childhood adversity will have more difficulty with M-I synchrony, due in part to a dampened OXT system, and will benefit from interventions that improve responsive, nurturing, engagement by epigenetic regulation of the OXT system. Most interventions are costly, complex, and time-consuming. The investigators aim to fill this gap by testing whether a simple early behavioral intervention (ATVV) will improve OXT system function and M-I synchrony in mothers with childhood adversity.

The ATVV (Auditory, Tactile, Visual, Vestibular) is a 15-minute behavioral intervention that is a multisensory infant massage contingent on infant cues. The investigators extend the known success of ATVV with preterm infants to full-term infants. The investigators will compare M-I synchrony at 3 postnatal months in 250 first-time mothers (and their full-term infants) randomized to apply ATVV daily from birth to 3 months (n =125) or receive infant care education in an attention control group (n = 125). The investigators apply a rigorous measure of M-I synchrony that micro-codes video-recorded M-I behavior quantifying shared gaze, affect, speech, and touch. Coding requires only 3-minutes of interaction and is valid when infants can reliably interact starting by 3 months of age. The investigators will also assess ATVV's effect on maternal and infant peripheral OXT level, a known biomarker of M-I synchrony. OXT levels relate to quality of M-I synchrony, yet the investigators extend this knowledge to identify an epigenetic role of the oxytocin receptor gene (OXTR). The investigators will analyze maternal plasma for OXTR methylation, OXTR gene expression, OXTR protein, and oxytocin peptide in pregnancy, and at 1, 2, and 3 postnatal months (along with infant saliva OXT).

The investigators propose a single-site, randomized, two-group, attention-controlled clinical trial (N=250 M-I dyads) to test the efficacy of the ATVV multisensory behavioral intervention to improve OXT system function and M-I synchrony. Adult, nulliparous, English or Spanish speaking women carrying a single fetus, and scoring 2 or higher on the Adverse Childhood Experiences scale will be enrolled. The investigators will obtain baseline OXT, demographics and survey data in the third trimester. Soon after birth (pre-hospital discharge), M-I dyads who continue to be eligible (e.g., full-term gestation) are randomized into the intervention group (n = 125) and taught to administer ATVV daily for 3 months or randomized into the Attention Control group (n = 125) and taught normal safe infant care. There are postnatal study visits at 1, 2 and 3 months. The investigators follow-up with a phone call at 6 postnatal months (3-months after the intervention period ends) to assess self-report parenting behavior (a proxy for quality of M-I interaction) that the investigators also measure at postnatal months 1, 2, and 3.

Aim 1: Evaluate the efficacy of daily ATVV over 3 postnatal months among mothers with childhood adversity. The investigators hypothesize that compared to the Attention Control group (n=125), M-I dyads in the ATVV group (n=125) will exhibit:

H1: Higher oxytocin function (i.e., decreased OXTR methylation at candidate sites, and increased OXTR messenger ribonucleic acid (mRNA), OXTR protein, and OXT in maternal plasma, and increased OXT in infant saliva) at 1, 2, and 3 postnatal months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The video coders measuring mother-infant synchrony will be blinded to group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy (gestational diabetes is acceptable)
  • •Greater than or equal to 18 years old
  • •Nulliparous (previous miscarriage(s) and/or abortion(s) acceptable)
  • •Speak and read English or Spanish
  • •Score greater than or equal to 2 on the Adverse Childhood Experience (ACE) survey
  • •Expect to deliver a healthy infant
  • •Expect to deliver a full-term infant (greater than or equal to 37 weeks and 0/7 days)
  • •Expect to deliver a singleton infant

排除标准

  • •Multiparous
  • •Have no access to a cell phone during the first 3 postnatal months
  • •Carrying multiple fetuses
  • •Taking anti-depressant(s) during pregnancy
  • •Taking illicit drugs
  • •Do not speak and read English or Spanish;
  • •Under 18 years of age
  • •Score less than 2 on the Adverse Childhood Experience (ACE) survey
  • •Deliver an infant diagnosed with conditions that could affect normal development or the oxytocin system
  • •Pre-term gestation (less than 37 weeks and 0/7 days)
  • •Intrauterine growth retardation (IGR)
  • •Small for gestational age (SGA)
  • •Chromosomal anomaly including
  • •Down syndrome (trisomy 21)
  • •Trisomy 13
  • •trisomy 18
  • •Klinefelter syndrome
  • •Turner syndrome
  • •Triple X syndrome
  • •Congenital anomaly including
  • •Heart defect
  • •Musculoskeletal defect
  • •Neural tube defect
  • •Cystic Fibrosis
  • •Haemophilia
  • •Microcephaly

研究组 & 干预措施

Behavioral ATVV intervention

Experimental

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

干预措施: ATVV (Behavioral)

Attention control

Active Comparator

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

干预措施: Attention control (Behavioral)

结局指标

主要结局

Mother-Infant Synchrony, Gaze and Affect

时间窗: 84 +/- 7days from birth (approximately 3 months after birth)

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.

Mother-Infant Synchrony, Gaze and Affect

时间窗: 84 +/- 7days from birth (approximately 3 months after birth)

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.

次要结局

  • Mother-Infant Synchrony, Vocalization and Touch(84 +/- 7days from birth (approximately 3 months after birth))
  • Mother-Infant Synchrony, Vocalization and Touch(84 +/- 7days from birth (approximately 3 months after birth))
  • Oxytocin Receptor Gene DNA Methylation Reflecting Epigenetic Marks(Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months)
  • Oxytocin Receptor Gene Expression(Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months)
  • Oxytocin Receptor Protein(Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months)
  • Oxytocin Peptide, Maternal Plasma(Baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months)
  • Oxytocin Peptide, Infant Saliva(Every 28 days +/- 7 days from birth to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleeca Bell

Associate Professor

University of Arizona

研究点 (2)

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