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临床试验/NCT05781100
NCT05781100招募中不适用

Maternal Technology Use During Feeding and Infant Self-Regulation and Growth

California Polytechnic State University-San Luis Obispo2 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
345
试验地点
2
主要终点
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Sensitivity to Infant Cues during Feeding

研究概览

简要总结

Maternal sensitivity and contingent responsiveness to infant behavioral cues is an important contributor to infants' developing capacities to self-regulate. During early infancy, feeding interactions comprise a significant portion of mother-infant dyadic interactions and high-quality feeding interactions provide both nutritive and socioemotional benefits; recent data suggest that, for many dyads, mothers' sensitive responsiveness during feeding interactions is routinely impacted by the omnipresence of portable technology. The objective of the proposed research is to better understand the development and possible impacts of maternal technology use on infant feeding interactions, emotion and intake regulation, and sociobehavioral and growth outcomes.

详细描述

The development of effective self-regulation is one of the most important achievements of early childhood and is associated with better stress reactivity, lower risk for internalizing and externalizing problems, and lower risk for obesity. During infancy, key interconnected domains of self-regulation include emotion (i.e., distress regulation) and feeding (i.e., caloric intake regulation). An important contributor to regulation across these domains is synchrony in caregiver-infant interactions, of which a critical component is caregiver sensitive responsiveness to infant cues. Feeding interactions comprise a majority of early interactions and high quality, synchronous feeding interactions provide the infant with both nutritive and socioemotional benefits.

Given recent increases in portable technology use over the past decade, as well as further increases due to social distancing in response to the COVID-19 pandemic, there is growing concern that the omnipresence of technology impacts the nature and quality of family interactions. The PI's previous research illustrates 92% of mothers reported engaging with technological distractors (e.g., watching TV, using mobile devices) during infant feeding and distracted mothers exhibited lower sensitivity than mothers who were not distracted. Short-term experimental studies illustrate maternal technology use reduces the quality of dyadic interaction by decreasing maternal engagement, reducing maternal responsiveness to infants' attention bids, and evoking undesirable infant responses, including increased negative affect and poorer focus. These findings are concerning, but the field is critically limited by a lack of longitudinal data to inform whether these short-term impacts are indicative of long-term detriments to infant development.

The present study is a novel longitudinal study featuring within-subject experimental manipulations and intensive assessments to better understand how maternal technology use impacts infant socioemotional, feeding, and growth outcomes. 345 women will be recruited during the 3rd trimester of pregnancy, then will be assessed 1, 4, 6, 9, and 12 months postpartum.

The following aims will be addressed:

Aim 1: Examine impacts of maternal technology use on early feeding interactions and change in these impacts across early infancy. At 1 month and 4 months, dyadic interactions will be observed during 3 counterbalanced within-subject experimental feeding conditions: 1) Control: mothers will not engage with TV or mobile devices; 2) TV Use: mothers will watch a TV show; 3) Mobile Device Use: mothers will use a mobile device. Videos of these interactions will be coded to obtain a comprehensive understanding of whether and how maternal technology use influences dyadic interactions, as well as potential bidirectional associations between maternal and infant behavioral responses. Experimental data will be combined with longitudinal data on habitual maternal technology use (see Aim 3) to understand: a) effects of experimentally-manipulated technology use on maternal attention, sensitivity to infant cues, and engagement of the infant, and on infant clarity of cues, attentional responsiveness to the mother, and intake; b) stability vs. change in these effects between 1mo and 4mo; c) moderating effects of habitual maternal technology use (assessed via passive sensing at 1mo and 4mo) on stability vs. change in behavioral responses to experimentally manipulated technology use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Video Coders and Investigators are masked to the condition the dyad is exposed to during video / data analysis.

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligibility Criteria
  • At the time of recruitment, eligibility criteria for participants will include:
  • 18 years of age or older
  • In 3rd trimester of singleton pregnancy
  • History of healthy, low-risk pregnancy
  • Lives within 50 miles of the Cal Poly campus
  • Owns a mobile device
  • After the child is born, eligibility criteria for participants will remain in the study will include:
  • Infant was born term (gestational age ≥37 weeks)

排除标准

  • Mother has an untreated medical or psychiatric condition (e.g. bipolar disorder) that could impede study participation or affect mother-infant interaction
  • Mother is participating in another interventional study that influences parenting, mother-infant interactions, feeding practices, or technology use
  • The mother is unwilling or unable to commit to longitudinal follow-ups of herself or her child
  • Infant was born preterm (gestational age <37 weeks)
  • Infant diagnosed with fetal abnormality or medical condition that interferes with oral feeding (e.g., feeding disorder, milk protein allergy) or development
  • Infant diagnosed with developmental delay (e.g., Down's syndrome)

结局指标

主要结局

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Sensitivity to Infant Cues during Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Maternal Sensitivity to Infant Cues subscale is 0-16 with higher scores representing greater maternal sensitivity to infant cues.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Attentional Responsiveness to the Mother during Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded to determine the percentage of time the infant spent looking at the mother, with greater percent time spent looking at the mother representing greater infant attentiveness to the mother.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Socioemotional Growth Fostering during Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Maternal Socioemotional Growth Fostering subscale is 0-14 with higher scores representing greater maternal socioemotional growth fostering.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Cognitive Growth Fostering during Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Maternal Cognitive Growth Fostering subscale is 0-9 with higher scores representing greater maternal cognitive growth fostering.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Attentiveness to the Infant during Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded to determine the percentage of time the mother spent looking at the device versus her infant, with greater percent time spent looking at the infant representing greater maternal attentiveness to the infant.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Clarity of Cues during Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Infant Clarity of Cues subscale is 0-15 with higher scores representing greater infant clarity of cues.

Change in Infant Intake Regulation between infant ages 4 months, 6 months, and 12 months

时间窗: Infant ages 4 months, 6 months, and 12 months

Infant intake regulation capacity will be assessed via both observational and maternal-reported measures. Infant intake regulation will be assessed via percent difference scores gleaned from the Caloric Compensation and COMPX protocols described in the intervention section. Maternal reported infant self-regulation of intake (satiety responsiveness) will also be assessing using the Baby Eating Behavior Questionnaire (BEBQ) at and the Child Eating Behavior Questionnaire for Toddlers (CEBQ-T). These observational and maternal-reported measures will be combined into a composite score representing infant intake regulation capacity. Greater scores will represent greater intake regulation capacity.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Intake Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. The infant will be weighed before and after feeding to determine amount consumed during the feeding.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Meal Duration

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded to determine the duration of the meal.

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Rate of Feeding

时间窗: Infant ages 1 month and 4 months

When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Infant intake (mL) will be divided by meal duration (min) to determine rate of feeding (mL/min).

Change Infant Emotion Regulation between infant ages 4 months, 6 months, and 12 months

时间窗: Infant ages 4 months, 6 months, and 12 months

Infant emotion regulation capacity will be assessed via both observational and maternal-reported measures. Observational measures will come from infant behavior during the Still Face Paradigm described in the intervention section; videos of infant behavior during this paradigm will be coded using the infant-caregiver engagement phases (ICEP). Maternal-reported emotion regulation will come from the Infant Behavior Questionnaire-Revised Very Short Form. These observational and maternal-reported measures will be combined into a composite score representing infant emotion regulation capacity. Greater scores will represent greater emotion regulation capacity.

Infant Socioemotional and Behavioral Problems

时间窗: Infant age 12 months

Mothers will complete the Brief Infant-Toddler Social Emotional Assessment (BITSEA), a 42-item questionnaire that indexes the presence of social-emotional and behavioral problems and competencies that has been extensively validated for use with children from 12-36 months of age. Broad domains assessed include Internalizing (depression/withdrawal, general anxiety, inhibition to novelty, separation distress subscales), Externalizing (activity/impulsivity, aggression/defiance, peer aggression subscales), Dysregulation (negative emotionality, sleep, eating, sensory sensitivity subscales), and Competence (compliance, attention, mastery motivation, imitation/play, empathy, prosocial peer relations subscales). A mean score will be calculated with higher scores indicating poorer socioemotional and behavioral adjustment.

Change in infant weight between birth and 12 months of age

时间窗: Birth to 12 months

A trained research assistant will collect infant weight and length measurements in triplicate using an infant scale/infantometer (models 374 and 233; Seca, Hamburg, Germany). Infant anthropometric data will be normalized to z-scores using the World Health Organization (WHO) Anthro software (http://www.who.int/childgrowth/en/) to calculate age- and sex-specific z-scores based on the WHO growth standards.

次要结局

  • Maternal habitual technology use(Prenatal to 12 months postpartum)

研究者

发起方
California Polytechnic State University-San Luis Obispo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alison Ventura

Professor

California Polytechnic State University-San Luis Obispo

研究点 (2)

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