Intervening With Opioid-Dependent MothersMothers and Infants

NCT04454645 | Completed DMC

• 2 other identifiers: mABC1R01HD098525-01A1
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence; Parenting; Infant Development

Outcome Measures

Primary Outcomes (26)

• 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 Outcomes (6)

• Maternal substance use

  Pre-intervention (3rd trimester)

• Maternal substance use

  Infant age of 12 months

• Maternal depression

  Pre-intervention (3rd trimester)

• Maternal depression

  Infant age of 12 months

• Maternal executive functioning

  Pre-intervention (3rd trimester)

Study Arms (2)

Modified ABC

EXPERIMENTAL

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

Behavioral: mABC

Modified DEF

ACTIVE COMPARATOR

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

Behavioral: mDEF

Interventions

mABC BEHAVIORAL

Intervention targets parenting sensitivity and nurturance.

Modified ABC

mDEF BEHAVIORAL

Intervention targets parenting enhancing infant cognitive development

Modified DEF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Delaware: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mary Dozier, Ph.D.

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: July 1, 2020
• Study Start: May 1, 2020
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

US (1)