Completed
NA
INTERVENTIONAL
NCT03891628
Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Detailed Description
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.
Interventions
Name:
Modified Attachment and Biobehavioral Catch-up
Type:
BEHAVIORAL
Description:
Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.
Name:
Modified Developmental Education for Families
Type:
BEHAVIORAL
Description:
Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.
Primary Outcomes
Measure:
Maternal sensitivity
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
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.
Measure:
Maternal sensitivity
TimeFrame:
Infant age 3 months
Description:
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.
Measure:
Maternal sensitivity
TimeFrame:
Infant age 6 months
Description:
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.
Measure:
Maternal sensitivity
TimeFrame:
Infant age 12 months
Description:
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.
Measure:
Maternal methylation of μ-opioid receptor (OPRM1) gene
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal methylation of μ-opioid receptor (OPRM1) gene
TimeFrame:
Infant age 3 months
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal methylation of μ-opioid receptor (OPRM1) gene
TimeFrame:
Infant age 6 months
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal methylation of μ-opioid receptor (OPRM1) gene
TimeFrame:
Infant age 12 months
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal methylation of oxytocin receptor (OXTR) gene
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal methylation of oxytocin receptor (OXTR) gene
TimeFrame:
Infant age 3 months
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal methylation of oxytocin receptor (OXTR) gene
TimeFrame:
Infant age 6 months
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal methylation of oxytocin receptor (OXTR) gene
TimeFrame:
Infant age 12 months
Description:
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Infant methylation of μ-opioid receptor (OPRM1) gene
TimeFrame:
Infant age 3 months
Description:
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Infant methylation of μ-opioid receptor (OPRM1) gene
TimeFrame:
Infant age 6 months
Description:
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Infant methylation of μ-opioid receptor (OPRM1) gene
TimeFrame:
Infant age 12 months
Description:
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Infant methylation of oxytocin receptor (OXTR) gene
TimeFrame:
Infant age 3 months
Description:
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Infant methylation of oxytocin receptor (OXTR) gene
TimeFrame:
Infant age 6 months
Description:
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Infant methylation of oxytocin receptor (OXTR) gene
TimeFrame:
Infant age 12 months
Description:
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measure:
Maternal neural activity (EEG) - Own child-other child task
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Measure:
Maternal neural activity (EEG) - Own child-other child task
TimeFrame:
Infant age 12 months
Description:
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Measure:
Maternal neural activity (EEG) - Reward sensitivity task
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
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.
Measure:
Maternal neural activity (EEG) - Reward sensitivity task
TimeFrame:
Infant age 12 months
Description:
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.
Measure:
Maternal neural activity (EEG) - Child emotion task
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Measure:
Maternal neural activity (EEG) - Child emotion task
TimeFrame:
Infant age 12 months
Description:
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Measure:
Maternal parasympathetic nervous system activity
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measure:
Maternal sympathetic nervous system activity
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measure:
Maternal parasympathetic nervous system activity
TimeFrame:
Infant age 3 months
Description:
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measure:
Maternal sympathetic nervous system activity
TimeFrame:
Infant age 3 months
Description:
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measure:
Maternal parasympathetic nervous system activity
TimeFrame:
Infant age 6 months
Description:
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measure:
Maternal sympathetic nervous system activity
TimeFrame:
Infant age 6 months
Description:
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measure:
Maternal parasympathetic nervous system activity
TimeFrame:
Infant age 12 months
Description:
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measure:
Maternal sympathetic nervous system activity
TimeFrame:
Infant age 12 months
Description:
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measure:
Infant parasympathetic nervous system activity
TimeFrame:
Infant age 3 months
Description:
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measure:
Infant sympathetic nervous system activity
TimeFrame:
Infant age 3 months
Description:
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Measure:
Infant parasympathetic nervous system activity
TimeFrame:
Infant age 6 months
Description:
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measure:
Infant sympathetic nervous system activity
TimeFrame:
Infant age 6 months
Description:
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Measure:
Infant parasympathetic nervous system activity
TimeFrame:
Infant age 12 months
Description:
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measure:
Infant sympathetic nervous system activity
TimeFrame:
Infant age 12 months
Description:
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Measure:
Maternal diurnal cortisol production
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measure:
Maternal diurnal cortisol production
TimeFrame:
Infant age 12 months
Description:
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measure:
Infant diurnal cortisol production
TimeFrame:
Infant age 3 months
Description:
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measure:
Infant diurnal cortisol production
TimeFrame:
Infant age 6 months
Description:
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measure:
Infant diurnal cortisol production
TimeFrame:
Infant age 12 months
Description:
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measure:
Infant behavioral regulation - Still Face Paradigm
TimeFrame:
Infant age 6 months
Description:
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Still Face Paradigm, a mild social stressor.
Measure:
Infant behavioral regulation - Arm Restraint Task
TimeFrame:
Infant age 12 months
Description:
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Arm Restraint Task, a mild stressor.
Measure:
Infant attachment
TimeFrame:
Infant age 12 months
Description:
Infant attachment will be assessed using the Strange Situation.
Measure:
Infant cognitive development
TimeFrame:
Infant age 3 months
Description:
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measure:
Infant motor development
TimeFrame:
Infant age 3 months
Description:
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measure:
Infant social-emotional development
TimeFrame:
Infant age 3 months
Description:
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Measure:
Infant cognitive development
TimeFrame:
Infant age 6 months
Description:
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measure:
Infant motor development
TimeFrame:
Infant age 6 months
Description:
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measure:
Infant social-emotional development
TimeFrame:
Infant age 6 months
Description:
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Measure:
Infant cognitive development
TimeFrame:
Infant age 12 months
Description:
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measure:
Infant motor development
TimeFrame:
Infant age 12 months
Description:
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measure:
Infant social-emotional development
TimeFrame:
Infant age 12 months
Description:
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Measure:
Infant social-emotional problems
TimeFrame:
Infant age 12 months
Description:
Infant social-emotional problems will be assessed through maternal report on the Brief Infant-Toddler Social Emotional Assessment.
Measure:
Maternal self-efficacy
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
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.
Measure:
Maternal self-efficacy
TimeFrame:
Infant age 12 months
Description:
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.
Measure:
Maternal emotion regulation
TimeFrame:
Pre-intervention (third trimester of gestation or up to one month postpartum)
Description:
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.
Measure:
Maternal emotion regulation
TimeFrame:
Infant age 12 months
Description:
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.
Trial Information
NCT ID
NCT03891628
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
University of Delaware
Last Updated
December 15, 2025