Clinical trial NCT03891628: Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants
Official title: Modified Attachment and Biobehavioral Catch-Up for Mothers and Their Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Parent-Child Relations
Infant Development
Parenting
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up 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 compared to infants of parents who receive the control intervention.

Detailed description: Peripartum 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 ABC 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 ABC 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 ABC intervention on improved infant outcomes.

Eligibility criteria: Inclusion Criteria:

* In third trimester of pregnancy or up to one month postpartum
* Receiving medication-assisted treatment for opioid use disorder

Exclusion Criteria:

* None

Primary outcomes:
measure: Maternal sensitivity
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal sensitivity
timeFrame: Infant age 3 months
measure: Maternal sensitivity
timeFrame: Infant age 6 months
measure: Maternal sensitivity
timeFrame: Infant age 12 months
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age 3 months
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age 6 months
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age 12 months
measure: Maternal methylation of oxytocin receptor (OXTR) gene
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal methylation of oxytocin receptor (OXTR) gene
timeFrame: Infant age 3 months
measure: Maternal methylation of oxytocin receptor (OXTR) gene
timeFrame: Infant age 6 months
measure: Maternal methylation of oxytocin receptor (OXTR) gene
timeFrame: Infant age 12 months
measure: Infant methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age 3 months
measure: Infant methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age 6 months
measure: Infant methylation of μ-opioid receptor (OPRM1) gene
timeFrame: Infant age 12 months
measure: Infant methylation of oxytocin receptor (OXTR) gene
timeFrame: Infant age 3 months
measure: Infant methylation of oxytocin receptor (OXTR) gene
timeFrame: Infant age 6 months
measure: Infant methylation of oxytocin receptor (OXTR) gene
timeFrame: Infant age 12 months
measure: Maternal neural activity (EEG) - Own child-other child task
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal neural activity (EEG) - Own child-other child task
timeFrame: Infant age 12 months
measure: Maternal neural activity (EEG) - Reward sensitivity task
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal neural activity (EEG) - Reward sensitivity task
timeFrame: Infant age 12 months
measure: Maternal neural activity (EEG) - Child emotion task
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal neural activity (EEG) - Child emotion task
timeFrame: Infant age 12 months
measure: Maternal parasympathetic nervous system activity
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal sympathetic nervous system activity
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal parasympathetic nervous system activity
timeFrame: Infant age 3 months
measure: Maternal sympathetic nervous system activity
timeFrame: Infant age 3 months
measure: Maternal parasympathetic nervous system activity
timeFrame: Infant age 6 months
measure: Maternal sympathetic nervous system activity
timeFrame: Infant age 6 months
measure: Maternal parasympathetic nervous system activity
timeFrame: Infant age 12 months
measure: Maternal sympathetic nervous system activity
timeFrame: Infant age 12 months
measure: Infant parasympathetic nervous system activity
timeFrame: Infant age 3 months
measure: Infant sympathetic nervous system activity
timeFrame: Infant age 3 months
measure: Infant parasympathetic nervous system activity
timeFrame: Infant age 6 months
measure: Infant sympathetic nervous system activity
timeFrame: Infant age 6 months
measure: Infant parasympathetic nervous system activity
timeFrame: Infant age 12 months
measure: Infant sympathetic nervous system activity
timeFrame: Infant age 12 months
measure: Maternal diurnal cortisol production
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal diurnal cortisol production
timeFrame: Infant age 12 months
measure: Infant diurnal cortisol production
timeFrame: Infant age 3 months
measure: Infant diurnal cortisol production
timeFrame: Infant age 6 months
measure: Infant diurnal cortisol production
timeFrame: Infant age 12 months
measure: Infant behavioral regulation - Still Face Paradigm
timeFrame: Infant age 6 months
measure: Infant behavioral regulation - Arm Restraint Task
timeFrame: Infant age 12 months
measure: Infant attachment
timeFrame: Infant age 12 months
measure: Infant cognitive development
timeFrame: Infant age 3 months
measure: Infant motor development
timeFrame: Infant age 3 months
measure: Infant social-emotional development
timeFrame: Infant age 3 months
measure: Infant cognitive development
timeFrame: Infant age 6 months
measure: Infant motor development
timeFrame: Infant age 6 months
measure: Infant social-emotional development
timeFrame: Infant age 6 months
measure: Infant cognitive development
timeFrame: Infant age 12 months
measure: Infant motor development
timeFrame: Infant age 12 months
measure: Infant social-emotional development
timeFrame: Infant age 12 months
measure: Infant social-emotional problems
timeFrame: Infant age 12 months
measure: Maternal self-efficacy
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal self-efficacy
timeFrame: Infant age 12 months
measure: Maternal emotion regulation
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal emotion regulation
timeFrame: Infant age 12 months
Secondary outcomes:
measure: Maternal substance use - interview
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal substance use - interview
timeFrame: Infant age 6 months
measure: Maternal substance use - interview
timeFrame: Infant age 12 months
measure: Maternal substance use - questionnaire
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal substance use - questionnaire
timeFrame: Infant age 3 months
measure: Maternal substance use - questionnaire
timeFrame: Infant age 6 months
measure: Maternal substance use - questionnaire
timeFrame: Infant age 12 months
measure: Maternal depressive symptoms
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal depressive symptoms
timeFrame: Infant age 3 months
measure: Maternal depressive symptoms
timeFrame: Infant age 6 months
measure: Maternal depressive symptoms
timeFrame: Infant age 12 months
measure: Infant physical growth
timeFrame: Infant age 3 months
measure: Infant physical growth
timeFrame: Infant age 6 months
measure: Infant physical growth
timeFrame: Infant age 12 months
measure: Maternal experiences during labor and delivery
timeFrame: Infant age 3 months
measure: Home environment
timeFrame: Infant age 3 months
measure: Maternal reward responsiveness
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal reward responsiveness
timeFrame: Infant age 12 months
measure: Maternal sleep
timeFrame: Pre-intervention (third trimester of gestation or up to one month postpartum)
measure: Maternal sleep
timeFrame: Infant age 3 months
measure: Maternal sleep
timeFrame: Infant age 6 months
measure: Maternal sleep
timeFrame: Infant age 12 months
measure: Infant sleep
timeFrame: Infant age 3 months
measure: Infant sleep
timeFrame: Infant age 6 months
measure: Infant sleep
timeFrame: Infant age 12 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
citation: Tabachnick AR, Eiden RD, Labella MH, Dozier M. Effects of an attachment-based intervention on autonomic regulation among opioid-exposed infants. Dev Psychobiol. 2022 Sep;64(6):e22286. doi: 10.1002/dev.22286.