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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
65
Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.
Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.
University of Delaware
Newark, Delaware, United States
Maternal sensitivity
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.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sensitivity
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.
Time frame: Infant age 3 months
Maternal sensitivity
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.
Time frame: Infant age 6 months
Maternal sensitivity
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.
Time frame: Infant age 12 months
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 3 months
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 6 months
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 12 months
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 3 months
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 6 months
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 12 months
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 3 months
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 6 months
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 12 months
Infant methylation of oxytocin receptor (OXTR) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 3 months
Infant methylation of oxytocin receptor (OXTR) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 6 months
Infant methylation of oxytocin receptor (OXTR) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Time frame: Infant age 12 months
Maternal neural activity (EEG) - Own child-other child task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal neural activity (EEG) - Own child-other child task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Time frame: Infant age 12 months
Maternal neural activity (EEG) - Reward sensitivity task
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.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal neural activity (EEG) - Reward sensitivity task
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.
Time frame: Infant age 12 months
Maternal neural activity (EEG) - Child emotion task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal neural activity (EEG) - Child emotion task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Time frame: Infant age 12 months
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Time frame: Infant age 3 months
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Time frame: Infant age 3 months
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Time frame: Infant age 6 months
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Time frame: Infant age 6 months
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Time frame: Infant age 12 months
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Time frame: Infant age 12 months
Infant parasympathetic nervous system activity
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Time frame: Infant age 3 months
Infant sympathetic nervous system activity
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Time frame: Infant age 3 months
Infant parasympathetic nervous system activity
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Time frame: Infant age 6 months
Infant sympathetic nervous system activity
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Time frame: Infant age 6 months
Infant parasympathetic nervous system activity
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Time frame: Infant age 12 months
Infant sympathetic nervous system activity
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Time frame: Infant age 12 months
Maternal diurnal cortisol production
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal diurnal cortisol production
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Time frame: Infant age 12 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Time frame: Infant age 3 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Time frame: Infant age 6 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Time frame: Infant age 12 months
Infant behavioral regulation - Still Face Paradigm
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Still Face Paradigm, a mild social stressor.
Time frame: Infant age 6 months
Infant behavioral regulation - Arm Restraint Task
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Arm Restraint Task, a mild stressor.
Time frame: Infant age 12 months
Infant attachment
Infant attachment will be assessed using the Strange Situation.
Time frame: Infant age 12 months
Infant cognitive development
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Time frame: Infant age 3 months
Infant motor development
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Time frame: Infant age 3 months
Infant social-emotional development
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Time frame: Infant age 3 months
Infant cognitive development
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Time frame: Infant age 6 months
Infant motor development
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Time frame: Infant age 6 months
Infant social-emotional development
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Time frame: Infant age 6 months
Infant cognitive development
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Time frame: Infant age 12 months
Infant motor development
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Time frame: Infant age 12 months
Infant social-emotional development
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Time frame: Infant age 12 months
Infant social-emotional problems
Infant social-emotional problems will be assessed through maternal report on the Brief Infant-Toddler Social Emotional Assessment.
Time frame: Infant age 12 months
Maternal self-efficacy
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.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal self-efficacy
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.
Time frame: Infant age 12 months
Maternal emotion regulation
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.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal emotion regulation
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.
Time frame: Infant age 12 months
Maternal substance use - interview
The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal substance use - interview
The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
Time frame: Infant age 6 months
Maternal substance use - interview
The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
Time frame: Infant age 12 months
Maternal substance use - questionnaire
Mothers will report their history of substance use using the NIDA ASSIST questionnaire.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal substance use - questionnaire
Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
Time frame: Infant age 3 months
Maternal substance use - questionnaire
Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
Time frame: Infant age 6 months
Maternal substance use - questionnaire
Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
Time frame: Infant age 12 months
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
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Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
Time frame: Infant age 3 months
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
Time frame: Infant age 6 months
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
Time frame: Infant age 12 months
Infant physical growth
Infant physical growth will be assessed using weight, length, and head circumference.
Time frame: Infant age 3 months
Infant physical growth
Infant physical growth will be assessed using weight, length, and head circumference.
Time frame: Infant age 6 months
Infant physical growth
Infant physical growth will be assessed using weight, length, and head circumference.
Time frame: Infant age 12 months
Maternal experiences during labor and delivery
Mothers will report on their experiences during labor and delivery using the Birth Satisfaction Scale-Revised questionnaire (BSS-R). This measure consists of ten items rated on a 5-point scale from 1-Strongly Disagree to 5-Strongly Agree. The total score ranges from 10-50, where higher scores represent more birth satisfaction.
Time frame: Infant age 3 months
Home environment
The home environment will be assessed using the Cognitive Stimulation subscale of the HOME Short Form, a combination of observation (two items) and maternal report (seven items). Observation items are binary (yes/no), and mother-report items are rated on a Likert-type scale and dichotomized. Dichotomous items are summed to form a total score (range 0-9), with higher scores indicating more cognitive stimulation.
Time frame: Infant age 3 months
Maternal reward responsiveness
Mothers will report their reward responsiveness using the Reward Responsiveness Scale. This is an 8-item scale rated on a 4-point scale from 1-Strong Disagreement to 4-Strong Agreement. The total score ranges from 8 to 32, with higher scores representing greater reward responsiveness.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal reward responsiveness
Mothers will report their reward responsiveness using the Reward Responsiveness Scale. This is an 8-item scale rated on a 4-point scale from 1-Strong Disagreement to 4-Strong Agreement. The total score ranges from 8 to 32, with higher scores representing greater reward responsiveness.
Time frame: Infant age 12 months
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Time frame: Infant age 3 months
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Time frame: Infant age 6 months
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Time frame: Infant age 12 months
Infant sleep
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
Time frame: Infant age 3 months
Infant sleep
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
Time frame: Infant age 6 months
Infant sleep
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
Time frame: Infant age 12 months