Intervening With Opioid-Dependent MothersMothers and Infants

Parenting Clinical Trial

— mABC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454645
• Other study ID #: mABC
• Secondary ID: 1R01HD098525-01A
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2023
• Source: University of Delaware
• Contact: Mary Dozier, Ph.D.
• Phone: 3028312286
• Email: mdozier[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infant Development
• Opioid Dependence
• Opioid-Related Disorders
• Parenting

Intervention

Behavioral:
• mABC
Intervention targets parenting sensitivity and nurturance.
• mDEF
Intervention targets parenting enhancing infant cognitive development

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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