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Intervening With Opioid-Dependent MothersMothers and Infants (mABC)

Primary Purpose

Opioid Dependence, Parenting, Infant Development

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mABC
mDEF
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Dependence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment

Exclusion Criteria:

  • None

Sites / Locations

  • University of DelawareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified ABC

Modified DEF

Arm Description

12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.

12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
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.
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.
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.
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.
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.
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.
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.
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 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 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 diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
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 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 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 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.

Secondary Outcome Measures

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).
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).
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.)
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.)
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.
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.

Full Information

First Posted
April 9, 2020
Last Updated
March 9, 2023
Sponsor
University of Delaware
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04454645
Brief Title
Intervening With Opioid-Dependent MothersMothers and Infants
Acronym
mABC
Official Title
Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Parenting, Infant Development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified ABC
Arm Type
Experimental
Arm Description
12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
Arm Title
Modified DEF
Arm Type
Active Comparator
Arm Description
12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development
Intervention Type
Behavioral
Intervention Name(s)
mABC
Intervention Description
Intervention targets parenting sensitivity and nurturance.
Intervention Type
Behavioral
Intervention Name(s)
mDEF
Intervention Description
Intervention targets parenting enhancing infant cognitive development
Primary Outcome Measure Information:
Title
Maternal sensitivity
Description
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.
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal sensitivity
Description
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.
Time Frame
Infant age of 3 months
Title
Maternal sensitivity
Description
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.
Time Frame
Infant age of 6 months
Title
Maternal sensitivity
Description
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.
Time Frame
Infant age of 12 months
Title
Maternal methylation of μ-opioid receptor (OPRM1) gene
Description
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal methylation of μ-opioid receptor (OPRM1) gene
Description
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Time Frame
Infant age of 12 months
Title
Maternal methylation of oxytocin receptor (OXTR) gene
Description
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal methylation of oxytocin receptor (OXTR) gene
Description
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Time Frame
Infant age of 12 months
Title
Infant methylation of μ-opioid receptor (OPRM1) gene
Description
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Time Frame
Pre-intervention (3rd trimester)
Title
Infant methylation of μ-opioid receptor (OPRM1) gene
Description
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Time Frame
Infant age of 12 months
Title
Maternal neural activity (Event related potentials - ERP) - Own child-other child task
Description
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.
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal neural activity (Event related potentials - ERP) - Own child-other child task
Description
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.
Time Frame
Infant age of 12 months
Title
Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
Description
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.
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
Description
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.
Time Frame
Infant age of 12 months
Title
Maternal neural activity (Event related potentials - ERP) - Child emotion task
Description
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.
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal neural activity (Event related potentials - ERP) - Child emotion task
Description
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.
Time Frame
Infant age of 12 months
Title
Maternal parasympathetic nervous system activity during Still Face
Description
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.
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal parasympathetic nervous system activity
Description
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.
Time Frame
Infant age of 12 months
Title
Infant parasympathetic nervous system activity
Description
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.
Time Frame
Infant age of 6 months
Title
Infant parasympathetic nervous system activity
Description
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.
Time Frame
Infant age of 12 months
Title
Infant diurnal cortisol production
Description
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
Time Frame
Infant age of 6 months
Title
Infant diurnal cortisol production
Description
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
Time Frame
Infant age of 12 months
Title
Infant behavioral regulation
Description
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).
Time Frame
Infant age of 6 months
Title
Infant behavioral regulation
Description
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).
Time Frame
Infant age of 12 months
Title
Infant attachment
Description
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).
Time Frame
Infant age of 12 months
Title
Infant cognitive development
Description
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.
Time Frame
Infant age of 12 months
Secondary Outcome Measure Information:
Title
Maternal substance use
Description
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).
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal substance use
Description
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).
Time Frame
Infant age of 12 months
Title
Maternal depression
Description
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.)
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal depression
Description
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.)
Time Frame
Infant age of 12 months
Title
Maternal executive functioning
Description
Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.
Time Frame
Pre-intervention (3rd trimester)
Title
Maternal executive functioning
Description
Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.
Time Frame
Infant age of 12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Dozier, Ph.D.
Phone
3028312286
Email
mdozier@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Dozier, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Dozier, PhD

12. IPD Sharing Statement

Learn more about this trial

Intervening With Opioid-Dependent MothersMothers and Infants

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