Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modified Attachment and Biobehavioral Catch-Up for Mothers and Their Infants

Conditions
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Opioid-Related Disorders, Parent-Child Relations, Infant Development, Parenting

Intervention / Treatment
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* Behavioral: Modified Attachment and Biobehavioral Catch-up
* Behavioral: Modified Developmental Education for Families


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In third trimester of pregnancy or up to one month postpartum Receiving medication-assisted treatment for opioid use disorder Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified ABC<br>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) | Behavioral: Modified Attachment and Biobehavioral Catch-up<br>* Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.<br>* Other names: mABC;|
| Active Comparator: Modified DEF<br>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) | Behavioral: Modified Developmental Education for Families<br>* Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.<br>* Other names: mDEF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Infant age 12 months | 
| Maternal parasympathetic nervous system activity | Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. | 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. | 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. | Infant age 3 months | 
| Maternal sympathetic nervous system activity | Maternal sympathetic nervous system activity will be assessed using pre-ejection period. | Infant age 3 months | 
| Maternal parasympathetic nervous system activity | Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. | Infant age 6 months | 
| Maternal sympathetic nervous system activity | Maternal sympathetic nervous system activity will be assessed using pre-ejection period. | Infant age 6 months | 
| Maternal parasympathetic nervous system activity | Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. | Infant age 12 months | 
| Maternal sympathetic nervous system activity | Maternal sympathetic nervous system activity will be assessed using pre-ejection period. | Infant age 12 months | 
| Infant parasympathetic nervous system activity | Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. | Infant age 3 months | 
| Infant sympathetic nervous system activity | Infant sympathetic nervous system activity will be assessed using pre-ejection period. | Infant age 3 months | 
| Infant parasympathetic nervous system activity | Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. | Infant age 6 months | 
| Infant sympathetic nervous system activity | Infant sympathetic nervous system activity will be assessed using pre-ejection period. | Infant age 6 months | 
| Infant parasympathetic nervous system activity | Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. | Infant age 12 months | 
| Infant sympathetic nervous system activity | Infant sympathetic nervous system activity will be assessed using pre-ejection period. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Infant age 12 months | 
| Infant attachment | Infant attachment will be assessed using the Strange Situation. | Infant age 12 months | 
| Infant cognitive development | Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. | Infant age 3 months | 
| Infant motor development | Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire. | 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. | Infant age 3 months | 
| Infant cognitive development | Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. | Infant age 6 months | 
| Infant motor development | Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire. | 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. | Infant age 6 months | 
| Infant cognitive development | Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. | Infant age 12 months | 
| Infant motor development | Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire. | 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. | 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. | 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. | 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. | 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. | 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. | Infant age 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal substance use - interview | The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances. | 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. | 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. | Infant age 12 months | 
| Maternal substance use - questionnaire | Mothers will report their history of substance use using the NIDA ASSIST questionnaire. | 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. | Infant age 3 months | 
| Maternal substance use - questionnaire | Mothers will report recent substance use using the NIDA Quick Screen questionnaire. | Infant age 6 months | 
| Maternal substance use - questionnaire | Mothers will report recent substance use using the NIDA Quick Screen questionnaire. | Infant age 12 months | 
| Maternal depressive symptoms | Maternal depressive symptoms will be self-reported using the Beck Depression Inventory. | 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. | Infant age 3 months | 
| Maternal depressive symptoms | Maternal depressive symptoms will be self-reported using the Beck Depression Inventory. | Infant age 6 months | 
| Maternal depressive symptoms | Maternal depressive symptoms will be self-reported using the Beck Depression Inventory. | Infant age 12 months | 
| Infant physical growth | Infant physical growth will be assessed using weight, length, and head circumference. | Infant age 3 months | 
| Infant physical growth | Infant physical growth will be assessed using weight, length, and head circumference. | Infant age 6 months | 
| Infant physical growth | Infant physical growth will be assessed using weight, length, and head circumference. | 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. | 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. | 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. | 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. | Infant age 12 months | 
| Maternal sleep | Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index. | 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. | Infant age 3 months | 
| Maternal sleep | Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index. | Infant age 6 months | 
| Maternal sleep | Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index. | Infant age 12 months | 
| Infant sleep | Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire. | Infant age 3 months | 
| Infant sleep | Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire. | Infant age 6 months | 
| Infant sleep | Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire. | Infant age 12 months |