Clinical trial NCT04454645: Intervening With Opioid-Dependent MothersMothers and Infants
Official title: Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Dependence
Parenting
Infant Development
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-07-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Maternal sensitivity
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal sensitivity
timeFrame: Infant age of 3 months
measure: Maternal sensitivity
timeFrame: Infant age of 6 months
measure: Maternal sensitivity
timeFrame: Infant age of 12 months
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age of 12 months
measure: Maternal methylation of oxytocin receptor (OXTR) gene
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal methylation of oxytocin receptor (OXTR) gene
timeFrame: Infant age of 12 months
measure: Infant methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Pre-intervention (3rd trimester)
measure: Infant methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age of 12 months
measure: Maternal neural activity (Event related potentials - ERP) - Own child-other child task
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal neural activity (Event related potentials - ERP) - Own child-other child task
timeFrame: Infant age of 12 months
measure: Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
timeFrame: Infant age of 12 months
measure: Maternal neural activity (Event related potentials - ERP) - Child emotion task
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal neural activity (Event related potentials - ERP) - Child emotion task
timeFrame: Infant age of 12 months
measure: Maternal parasympathetic nervous system activity during Still Face
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal parasympathetic nervous system activity
timeFrame: Infant age of 12 months
measure: Infant parasympathetic nervous system activity
timeFrame: Infant age of 6 months
measure: Infant parasympathetic nervous system activity
timeFrame: Infant age of 12 months
measure: Infant diurnal cortisol production
timeFrame: Infant age of 6 months
measure: Infant diurnal cortisol production
timeFrame: Infant age of 12 months
measure: Infant behavioral regulation
timeFrame: Infant age of 6 months
measure: Infant behavioral regulation
timeFrame: Infant age of 12 months
measure: Infant attachment
timeFrame: Infant age of 12 months
measure: Infant cognitive development
timeFrame: Infant age of 12 months
Secondary outcomes:
measure: Maternal substance use
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal substance use
timeFrame: Infant age of 12 months
measure: Maternal depression
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal depression
timeFrame: Infant age of 12 months
measure: Maternal executive functioning
timeFrame: Pre-intervention (3rd trimester)
measure: Maternal executive functioning
timeFrame: Infant age of 12 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Mary Dozier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: