- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03891628
Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants (mABC)
Modified Attachment and Biobehavioral Catch-Up for Mothers and Their Infants
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19716
- University of Delaware
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- In third trimester of pregnancy or up to one month postpartum
- Receiving medication-assisted treatment for opioid use disorder
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Modified ABC
Modified Attachment and Biobehavioral Catch-Up (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits)
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Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.
Other Names:
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ACTIVE_COMPARATOR: Modified DEF
Modified Developmental Education for Families (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits)
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Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal sensitivity
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Maternal sensitivity will be coded observationally from maternal interactions with an infant simulator pre-programmed to coo and then cry.
Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic.
Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal sensitivity
Time Frame: Infant age 3 months
|
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would.
Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic.
Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
|
Infant age 3 months
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Maternal sensitivity
Time Frame: Infant age 6 months
|
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would.
Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic.
Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
|
Infant age 6 months
|
Maternal sensitivity
Time Frame: Infant age 12 months
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Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would.
Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic.
Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
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Infant age 12 months
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Maternal methylation of μ-opioid receptor (OPRM1) gene
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Maternal methylation of μ-opioid receptor (OPRM1) gene
Time Frame: Infant age 3 months
|
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Infant age 3 months
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Maternal methylation of μ-opioid receptor (OPRM1) gene
Time Frame: Infant age 6 months
|
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Infant age 6 months
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Maternal methylation of μ-opioid receptor (OPRM1) gene
Time Frame: Infant age 12 months
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Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Infant age 12 months
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Maternal methylation of oxytocin receptor (OXTR) gene
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal methylation of oxytocin receptor (OXTR) gene
Time Frame: Infant age 3 months
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Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Infant age 3 months
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Maternal methylation of oxytocin receptor (OXTR) gene
Time Frame: Infant age 6 months
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Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Infant age 6 months
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Maternal methylation of oxytocin receptor (OXTR) gene
Time Frame: Infant age 12 months
|
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Infant age 12 months
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Infant methylation of μ-opioid receptor (OPRM1) gene
Time Frame: Infant age 3 months
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Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
|
Infant age 3 months
|
Infant methylation of μ-opioid receptor (OPRM1) gene
Time Frame: Infant age 6 months
|
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
|
Infant age 6 months
|
Infant methylation of μ-opioid receptor (OPRM1) gene
Time Frame: Infant age 12 months
|
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
|
Infant age 12 months
|
Infant methylation of oxytocin receptor (OXTR) gene
Time Frame: Infant age 3 months
|
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
|
Infant age 3 months
|
Infant methylation of oxytocin receptor (OXTR) gene
Time Frame: Infant age 6 months
|
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
|
Infant age 6 months
|
Infant methylation of oxytocin receptor (OXTR) gene
Time Frame: Infant age 12 months
|
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
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Infant age 12 months
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Maternal neural activity (EEG) - Own child-other child task
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal neural activity (EEG) - Own child-other child task
Time Frame: Infant age 12 months
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Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
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Infant age 12 months
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Maternal neural activity (EEG) - Reward sensitivity task
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal neural activity (EEG) - Reward sensitivity task
Time Frame: Infant age 12 months
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Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images.
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Infant age 12 months
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Maternal neural activity (EEG) - Child emotion task
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal neural activity (EEG) - Child emotion task
Time Frame: Infant age 12 months
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Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
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Infant age 12 months
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Maternal parasympathetic nervous system activity
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal sympathetic nervous system activity
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal parasympathetic nervous system activity
Time Frame: Infant age 3 months
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Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
|
Infant age 3 months
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Maternal sympathetic nervous system activity
Time Frame: Infant age 3 months
|
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
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Infant age 3 months
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Maternal parasympathetic nervous system activity
Time Frame: Infant age 6 months
|
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
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Infant age 6 months
|
Maternal sympathetic nervous system activity
Time Frame: Infant age 6 months
|
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
|
Infant age 6 months
|
Maternal parasympathetic nervous system activity
Time Frame: Infant age 12 months
|
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
|
Infant age 12 months
|
Maternal sympathetic nervous system activity
Time Frame: Infant age 12 months
|
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
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Infant age 12 months
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Infant parasympathetic nervous system activity
Time Frame: Infant age 3 months
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Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
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Infant age 3 months
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Infant sympathetic nervous system activity
Time Frame: Infant age 3 months
|
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
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Infant age 3 months
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Infant parasympathetic nervous system activity
Time Frame: Infant age 6 months
|
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
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Infant age 6 months
|
Infant sympathetic nervous system activity
Time Frame: Infant age 6 months
|
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
|
Infant age 6 months
|
Infant parasympathetic nervous system activity
Time Frame: Infant age 12 months
|
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
|
Infant age 12 months
|
Infant sympathetic nervous system activity
Time Frame: Infant age 12 months
|
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
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Infant age 12 months
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Maternal diurnal cortisol production
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal diurnal cortisol production
Time Frame: Infant age 12 months
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Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
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Infant age 12 months
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Infant diurnal cortisol production
Time Frame: Infant age 3 months
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Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
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Infant age 3 months
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Infant diurnal cortisol production
Time Frame: Infant age 6 months
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Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
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Infant age 6 months
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Infant diurnal cortisol production
Time Frame: Infant age 12 months
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Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
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Infant age 12 months
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Infant behavioral regulation - Still Face Paradigm
Time Frame: Infant age 6 months
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Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Still Face Paradigm, a mild social stressor.
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Infant age 6 months
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Infant behavioral regulation - Arm Restraint Task
Time Frame: Infant age 12 months
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Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Arm Restraint Task, a mild stressor.
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Infant age 12 months
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Infant attachment
Time Frame: Infant age 12 months
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Infant attachment will be assessed using the Strange Situation.
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Infant age 12 months
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Infant cognitive development
Time Frame: Infant age 3 months
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Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
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Infant age 3 months
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Infant motor development
Time Frame: Infant age 3 months
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Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
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Infant age 3 months
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Infant social-emotional development
Time Frame: Infant age 3 months
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Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
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Infant age 3 months
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Infant cognitive development
Time Frame: Infant age 6 months
|
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
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Infant age 6 months
|
Infant motor development
Time Frame: Infant age 6 months
|
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
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Infant age 6 months
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Infant social-emotional development
Time Frame: Infant age 6 months
|
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
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Infant age 6 months
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Infant cognitive development
Time Frame: Infant age 12 months
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Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
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Infant age 12 months
|
Infant motor development
Time Frame: Infant age 12 months
|
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
|
Infant age 12 months
|
Infant social-emotional development
Time Frame: Infant age 12 months
|
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
|
Infant age 12 months
|
Infant social-emotional problems
Time Frame: Infant age 12 months
|
Infant social-emotional problems will be assessed through maternal report on the Brief Infant-Toddler Social Emotional Assessment.
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Infant age 12 months
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Maternal self-efficacy
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Mothers will report on their parenting self-efficacy using the Maternal Self-Efficacy Scale.
Mothers will rate their self-efficacy for each of ten items (nine discrete parenting behaviors and one global parenting item) on a 4-point scale from 1-not good at all to 4-very good.
Scores are summed to form a total maternal self-efficacy composite (possible range = 10-40), where higher scores indicated more maternal self-efficacy.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal self-efficacy
Time Frame: Infant age 12 months
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Mothers will report on their parenting self-efficacy using the Maternal Self-Efficacy Scale.
Mothers will rate their self-efficacy for each of ten items (nine discrete parenting behaviors and one global parenting item) on a 4-point scale from 1-not good at all to 4-very good.
Scores are summed to form a total maternal self-efficacy composite (possible range = 10-40), where higher scores indicated more maternal self-efficacy.
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Infant age 12 months
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Maternal emotion regulation
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Mothers will report on their emotion regulation using the Difficulties with Emotion Regulation Scale - Short Form (DERS-SF).
The DERS-SF consists of 18 items rated on a scale from 1-almost never to 5-almost always.
The DERS-SF yields six subscales (strategies, non-acceptance, impulse, goals, awareness, and clarity), each of which range from 3 to 15, and one total score, which ranges from 18 to 90.
Higher scores indicate greater emotion dysregulation.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Maternal emotion regulation
Time Frame: Infant age 12 months
|
Mothers will report on their emotion regulation using the Difficulties with Emotion Regulation Scale - Short Form (DERS-SF).
The DERS-SF consists of 18 items rated on a scale from 1-almost never to 5-almost always.
The DERS-SF yields six subscales (strategies, non-acceptance, impulse, goals, awareness, and clarity), each of which range from 3 to 15, and one total score, which ranges from 18 to 90.
Higher scores indicate greater emotion dysregulation.
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Infant age 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal substance use - interview
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
|
The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal substance use - interview
Time Frame: Infant age 6 months
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The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
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Infant age 6 months
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Maternal substance use - interview
Time Frame: Infant age 12 months
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The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
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Infant age 12 months
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Maternal substance use - questionnaire
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Mothers will report their history of substance use using the NIDA ASSIST questionnaire.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal substance use - questionnaire
Time Frame: Infant age 3 months
|
Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
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Infant age 3 months
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Maternal substance use - questionnaire
Time Frame: Infant age 6 months
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Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
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Infant age 6 months
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Maternal substance use - questionnaire
Time Frame: Infant age 12 months
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Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
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Infant age 12 months
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Maternal depressive symptoms
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
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Maternal depressive symptoms
Time Frame: Infant age 3 months
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Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
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Infant age 3 months
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Maternal depressive symptoms
Time Frame: Infant age 6 months
|
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
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Infant age 6 months
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Maternal depressive symptoms
Time Frame: Infant age 12 months
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Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
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Infant age 12 months
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Infant physical growth
Time Frame: Infant age 3 months
|
Infant physical growth will be assessed using weight, length, and head circumference.
|
Infant age 3 months
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Infant physical growth
Time Frame: Infant age 6 months
|
Infant physical growth will be assessed using weight, length, and head circumference.
|
Infant age 6 months
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Infant physical growth
Time Frame: Infant age 12 months
|
Infant physical growth will be assessed using weight, length, and head circumference.
|
Infant age 12 months
|
Maternal experiences during labor and delivery
Time Frame: Infant age 3 months
|
Mothers will report on their experiences during labor and delivery using the Birth Satisfaction Scale-Revised questionnaire (BSS-R).
This measure consists of ten items rated on a 5-point scale from 1-Strongly Disagree to 5-Strongly Agree.
The total score ranges from 10-50, where higher scores represent more birth satisfaction.
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Infant age 3 months
|
Home environment
Time Frame: Infant age 3 months
|
The home environment will be assessed using the Cognitive Stimulation subscale of the HOME Short Form, a combination of observation (two items) and maternal report (seven items).
Observation items are binary (yes/no), and mother-report items are rated on a Likert-type scale and dichotomized.
Dichotomous items are summed to form a total score (range 0-9), with higher scores indicating more cognitive stimulation.
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Infant age 3 months
|
Maternal reward responsiveness
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Mothers will report their reward responsiveness using the Reward Responsiveness Scale.
This is an 8-item scale rated on a 4-point scale from 1-Strong Disagreement to 4-Strong Agreement.
The total score ranges from 8 to 32, with higher scores representing greater reward responsiveness.
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Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Maternal reward responsiveness
Time Frame: Infant age 12 months
|
Mothers will report their reward responsiveness using the Reward Responsiveness Scale.
This is an 8-item scale rated on a 4-point scale from 1-Strong Disagreement to 4-Strong Agreement.
The total score ranges from 8 to 32, with higher scores representing greater reward responsiveness.
|
Infant age 12 months
|
Maternal sleep
Time Frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
|
Pre-intervention (third trimester of gestation or up to one month postpartum)
|
Maternal sleep
Time Frame: Infant age 3 months
|
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
|
Infant age 3 months
|
Maternal sleep
Time Frame: Infant age 6 months
|
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
|
Infant age 6 months
|
Maternal sleep
Time Frame: Infant age 12 months
|
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
|
Infant age 12 months
|
Infant sleep
Time Frame: Infant age 3 months
|
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
|
Infant age 3 months
|
Infant sleep
Time Frame: Infant age 6 months
|
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
|
Infant age 6 months
|
Infant sleep
Time Frame: Infant age 12 months
|
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
|
Infant age 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYC412125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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