Modified Attachment and Biobehavioral Catch-Up for Mothers and Their Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Maternal neural activity (EEG) - Own child-other child task
研究概览
简要总结
This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation compared to infants of parents who receive the control intervention.
详细描述
Peripartum mothers will be randomly assigned to receive the modified ABC intervention or the control intervention (modified DEF). Hypotheses relate to parent and child outcomes associated with the intervention.
Hypothesis 1: Compared to mothers who receive the control intervention, mothers who receive the ABC intervention will show more nurturing and sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production.
Hypothesis 2: Compared to infants of mothers who receive the control intervention, infants of mothers who receive the ABC intervention will show more organized and secure attachment patterns, better behavioral regulation during stressors, more advanced social-emotional development, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production.
Hypothesis 3: Enhanced maternal sensitivity will mediate effects of the ABC intervention on improved infant outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In third trimester of pregnancy or up to one month postpartum
- •Receiving medication-assisted treatment for opioid use disorder
排除标准
- 未提供
研究组 & 干预措施
Modified ABC
Modified Attachment and Biobehavioral Catch-Up (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits)
干预措施: Modified Attachment and Biobehavioral Catch-up (Behavioral)
Modified DEF
Modified Developmental Education for Families (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits)
干预措施: Modified Developmental Education for Families (Behavioral)
结局指标
主要结局
Maternal neural activity (EEG) - Own child-other child task
时间窗: Infant age 12 months
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Infant diurnal cortisol production
时间窗: Infant age 12 months
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant behavioral regulation - Still Face Paradigm
时间窗: Infant age 6 months
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Still Face Paradigm, a mild social stressor.
Infant behavioral regulation - Arm Restraint Task
时间窗: Infant age 12 months
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Arm Restraint Task, a mild stressor.
Infant social-emotional problems
时间窗: Infant age 12 months
Infant social-emotional problems will be assessed through maternal report on the Brief Infant-Toddler Social Emotional Assessment.
Maternal neural activity (EEG) - Child emotion task
时间窗: Infant age 12 months
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Maternal parasympathetic nervous system activity
时间窗: Infant age 12 months
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Maternal sensitivity
时间窗: Infant age 12 months
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic. Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
Maternal methylation of oxytocin receptor (OXTR) gene
时间窗: Infant age 12 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of μ-opioid receptor (OPRM1) gene
时间窗: Infant age 12 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant parasympathetic nervous system activity
时间窗: Infant age 12 months
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Infant cognitive development
时间窗: Infant age 12 months
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant methylation of oxytocin receptor (OXTR) gene
时间窗: Infant age 12 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal neural activity (EEG) - Reward sensitivity task
时间窗: Infant age 12 months
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images.
Maternal sympathetic nervous system activity
时间窗: Infant age 12 months
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Infant sympathetic nervous system activity
时间窗: Infant age 12 months
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Infant social-emotional development
时间窗: Infant age 12 months
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Maternal methylation of μ-opioid receptor (OPRM1) gene
时间窗: Infant age 12 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal diurnal cortisol production
时间窗: Infant age 12 months
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant attachment
时间窗: Infant age 12 months
Infant attachment will be assessed using the Strange Situation.
Infant motor development
时间窗: Infant age 12 months
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Maternal self-efficacy
时间窗: Infant age 12 months
Mothers will report on their parenting self-efficacy using the Maternal Self-Efficacy Scale. Mothers will rate their self-efficacy for each of ten items (nine discrete parenting behaviors and one global parenting item) on a 4-point scale from 1-not good at all to 4-very good. Scores are summed to form a total maternal self-efficacy composite (possible range = 10-40), where higher scores indicated more maternal self-efficacy.
Maternal emotion regulation
时间窗: Infant age 12 months
Mothers will report on their emotion regulation using the Difficulties with Emotion Regulation Scale - Short Form (DERS-SF). The DERS-SF consists of 18 items rated on a scale from 1-almost never to 5-almost always. The DERS-SF yields six subscales (strategies, non-acceptance, impulse, goals, awareness, and clarity), each of which range from 3 to 15, and one total score, which ranges from 18 to 90. Higher scores indicate greater emotion dysregulation.
Maternal sensitivity
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sensitivity will be coded observationally from maternal interactions with an infant simulator pre-programmed to coo and then cry. Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic. Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
Maternal sensitivity
时间窗: Infant age 3 months
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic. Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
Maternal sensitivity
时间窗: Infant age 6 months
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic. Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
Maternal methylation of μ-opioid receptor (OPRM1) gene
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of μ-opioid receptor (OPRM1) gene
时间窗: Infant age 3 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of μ-opioid receptor (OPRM1) gene
时间窗: Infant age 6 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of oxytocin receptor (OXTR) gene
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of oxytocin receptor (OXTR) gene
时间窗: Infant age 3 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of oxytocin receptor (OXTR) gene
时间窗: Infant age 6 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of μ-opioid receptor (OPRM1) gene
时间窗: Infant age 3 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of μ-opioid receptor (OPRM1) gene
时间窗: Infant age 6 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of oxytocin receptor (OXTR) gene
时间窗: Infant age 3 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of oxytocin receptor (OXTR) gene
时间窗: Infant age 6 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal neural activity (EEG) - Own child-other child task
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Maternal neural activity (EEG) - Reward sensitivity task
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images.
Maternal neural activity (EEG) - Child emotion task
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Maternal parasympathetic nervous system activity
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Maternal sympathetic nervous system activity
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Maternal parasympathetic nervous system activity
时间窗: Infant age 3 months
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Maternal sympathetic nervous system activity
时间窗: Infant age 3 months
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Maternal parasympathetic nervous system activity
时间窗: Infant age 6 months
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Maternal sympathetic nervous system activity
时间窗: Infant age 6 months
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Infant parasympathetic nervous system activity
时间窗: Infant age 3 months
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Infant sympathetic nervous system activity
时间窗: Infant age 3 months
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Infant parasympathetic nervous system activity
时间窗: Infant age 6 months
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Infant sympathetic nervous system activity
时间窗: Infant age 6 months
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Maternal diurnal cortisol production
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant diurnal cortisol production
时间窗: Infant age 3 months
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant diurnal cortisol production
时间窗: Infant age 6 months
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant cognitive development
时间窗: Infant age 3 months
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant motor development
时间窗: Infant age 3 months
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant social-emotional development
时间窗: Infant age 3 months
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Infant cognitive development
时间窗: Infant age 6 months
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant motor development
时间窗: Infant age 6 months
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant social-emotional development
时间窗: Infant age 6 months
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Maternal self-efficacy
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Mothers will report on their parenting self-efficacy using the Maternal Self-Efficacy Scale. Mothers will rate their self-efficacy for each of ten items (nine discrete parenting behaviors and one global parenting item) on a 4-point scale from 1-not good at all to 4-very good. Scores are summed to form a total maternal self-efficacy composite (possible range = 10-40), where higher scores indicated more maternal self-efficacy.
Maternal emotion regulation
时间窗: Pre-intervention (third trimester of gestation or up to one month postpartum)
Mothers will report on their emotion regulation using the Difficulties with Emotion Regulation Scale - Short Form (DERS-SF). The DERS-SF consists of 18 items rated on a scale from 1-almost never to 5-almost always. The DERS-SF yields six subscales (strategies, non-acceptance, impulse, goals, awareness, and clarity), each of which range from 3 to 15, and one total score, which ranges from 18 to 90. Higher scores indicate greater emotion dysregulation.
次要结局
- Maternal depressive symptoms(Infant age 12 months)
- Maternal experiences during labor and delivery(Infant age 3 months)
- Infant sleep(Infant age 12 months)
- Maternal substance use - interview(Infant age 12 months)
- Maternal sleep(Infant age 12 months)
- Maternal substance use - questionnaire(Infant age 12 months)
- Infant physical growth(Infant age 12 months)
- Home environment(Infant age 3 months)
- Maternal reward responsiveness(Infant age 12 months)
- Maternal substance use - interview(Pre-intervention (third trimester of gestation or up to one month postpartum))
- Maternal substance use - interview(Infant age 6 months)
- Maternal substance use - questionnaire(Pre-intervention (third trimester of gestation or up to one month postpartum))
- Maternal substance use - questionnaire(Infant age 3 months)
- Maternal substance use - questionnaire(Infant age 6 months)
- Maternal depressive symptoms(Pre-intervention (third trimester of gestation or up to one month postpartum))
- Maternal depressive symptoms(Infant age 3 months)
- Maternal depressive symptoms(Infant age 6 months)
- Infant physical growth(Infant age 3 months)
- Infant physical growth(Infant age 6 months)
- Infant sleep(Infant age 6 months)
- Maternal reward responsiveness(Pre-intervention (third trimester of gestation or up to one month postpartum))
- Maternal sleep(Pre-intervention (third trimester of gestation or up to one month postpartum))
- Maternal sleep(Infant age 3 months)
- Maternal sleep(Infant age 6 months)
- Infant sleep(Infant age 3 months)
研究者
Mary Dozier
Amy E. du Pont Chair of Child Development
University of Delaware