Intervening With Opioid-Dependent MothersMothers and 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 (mABC) 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 than infants of parents who receive the control intervention.

Detailed Description
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Pregnant 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 mABC 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 mABC 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 mABC intervention on improved infant outcomes.

Official Title
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Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation

Conditions
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Opioid Dependence, Parenting, Infant Development

Intervention / Treatment
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* Behavioral: mABC
* Behavioral: mDEF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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>12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior. | Behavioral: mABC<br>* Intervention targets parenting sensitivity and nurturance.<br>|
| Active Comparator: Modified DEF<br>12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development | Behavioral: mDEF<br>* Intervention targets parenting enhancing infant cognitive development<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal sensitivity | The mother will be assessed interacting with the infant simulator. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity. | Pre-intervention (3rd trimester) | 
| Maternal sensitivity | The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity. | Infant age of 3 months | 
| Maternal sensitivity | The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity. | Infant age of 6 months | 
| Maternal sensitivity | The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity. | Infant age of 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 (3rd trimester) | 
| Maternal methylation of μ-opioid receptor (OPRM1) gene | Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva | Infant age of 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 (3rd trimester) | 
| Maternal methylation of oxytocin receptor (OXTR) gene | Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva | Infant age of 12 months | 
| Infant methylation of μ-opioid receptor (OPRM1) gene | Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva | Pre-intervention (3rd trimester) | 
| Infant methylation of μ-opioid receptor (OPRM1) gene | Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva | Infant age of 12 months | 
| Maternal neural activity (Event related potentials - ERP) - Own child-other child task | Maternal event-related potentials (ERP) will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable. | Pre-intervention (3rd trimester) | 
| Maternal neural activity (Event related potentials - ERP) - Own child-other child task | Maternal event-related potentials will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable. | Infant age of 12 months | 
| Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task | Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable. | Pre-intervention (3rd trimester) | 
| Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task | Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable. | Infant age of 12 months | 
| Maternal neural activity (Event related potentials - ERP) - Child emotion task | Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable. | Pre-intervention (3rd trimester) | 
| Maternal neural activity (Event related potentials - ERP) - Child emotion task | Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable. | Infant age of 12 months | 
| Maternal parasympathetic nervous system activity during Still Face | The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable. | Pre-intervention (3rd trimester) | 
| Maternal parasympathetic nervous system activity | The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable. | Infant age of 12 months | 
| Infant parasympathetic nervous system activity | The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable. | Infant age of 6 months | 
| Infant parasympathetic nervous system activity | The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable. | Infant age of 12 months | 
| Infant diurnal cortisol production | Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time. | Infant age of 6 months | 
| Infant diurnal cortisol production | Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time. | Infant age of 12 months | 
| Infant behavioral regulation | Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9). | Infant age of 6 months | 
| Infant behavioral regulation | Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9). | Infant age of 12 months | 
| Infant attachment | Infant attachment will be assessed using the Strange Situation. Coding will be completed using the standard Strange Situation coding scheme (with 4 major categories, with secure preferable). | Infant age of 12 months | 
| Infant cognitive development | Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. Scores could range from 0-300 with higher scores reflecting higher functioning. | Infant age of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal substance use | Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited). | Pre-intervention (3rd trimester) | 
| Maternal substance use | Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited). | Infant age of 12 months | 
| Maternal depression | Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.) | Pre-intervention (3rd trimester) | 
| Maternal depression | Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.) | Infant age of 12 months | 
| Maternal executive functioning | Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning. | Pre-intervention (3rd trimester) | 
| Maternal executive functioning | Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning. | Infant age of 12 months |