NCT03891628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

2.6 years

First QC Date

February 21, 2019

Last Update Submit

August 30, 2021

Conditions

Opioid-Related DisordersParent-Child RelationsInfant DevelopmentParenting

Outcome Measures

Primary Outcomes (60)

  • Maternal sensitivity

    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.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal sensitivity

    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

  • Maternal sensitivity

    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

    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 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 (third trimester of gestation or up to one month postpartum)

  • Maternal methylation of μ-opioid receptor (OPRM1) gene

    Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.

    Infant age 3 months

  • Maternal methylation of μ-opioid receptor (OPRM1) gene

    Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.

    Infant age 6 months

  • Maternal methylation of μ-opioid receptor (OPRM1) gene

    Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.

    Infant age 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 (third trimester of gestation or up to one month postpartum)

  • Maternal methylation of oxytocin receptor (OXTR) gene

    Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.

    Infant age 3 months

  • Maternal methylation of oxytocin receptor (OXTR) gene

    Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.

    Infant age 6 months

  • Maternal methylation of oxytocin receptor (OXTR) gene

    Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.

    Infant age 12 months

  • Infant methylation of μ-opioid receptor (OPRM1) gene

    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

    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

    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

    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

    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

    Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.

    Infant age 12 months

  • Maternal neural activity (EEG) - Own child-other child task

    Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal neural activity (EEG) - Own child-other child task

    Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.

    Infant age 12 months

  • Maternal neural activity (EEG) - Reward sensitivity task

    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.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal neural activity (EEG) - Reward sensitivity task

    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.

    Infant age 12 months

  • Maternal neural activity (EEG) - Child emotion task

    Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal neural activity (EEG) - Child emotion task

    Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.

    Infant age 12 months

  • Maternal parasympathetic nervous system activity

    Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal sympathetic nervous system activity

    Maternal sympathetic nervous system activity will be assessed using pre-ejection period.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal parasympathetic nervous system activity

    Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.

    Infant age 3 months

  • Maternal sympathetic nervous system activity

    Maternal sympathetic nervous system activity will be assessed using pre-ejection period.

    Infant age 3 months

  • Maternal parasympathetic nervous system activity

    Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.

    Infant age 6 months

  • Maternal sympathetic nervous system activity

    Maternal sympathetic nervous system activity will be assessed using pre-ejection period.

    Infant age 6 months

  • Maternal parasympathetic nervous system activity

    Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.

    Infant age 12 months

  • Maternal sympathetic nervous system activity

    Maternal sympathetic nervous system activity will be assessed using pre-ejection period.

    Infant age 12 months

  • Infant parasympathetic nervous system activity

    Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.

    Infant age 3 months

  • Infant sympathetic nervous system activity

    Infant sympathetic nervous system activity will be assessed using pre-ejection period.

    Infant age 3 months

  • Infant parasympathetic nervous system activity

    Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.

    Infant age 6 months

  • Infant sympathetic nervous system activity

    Infant sympathetic nervous system activity will be assessed using pre-ejection period.

    Infant age 6 months

  • Infant parasympathetic nervous system activity

    Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.

    Infant age 12 months

  • Infant sympathetic nervous system activity

    Infant sympathetic nervous system activity will be assessed using pre-ejection period.

    Infant age 12 months

  • Maternal diurnal cortisol production

    Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal diurnal cortisol production

    Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.

    Infant age 12 months

  • Infant diurnal cortisol production

    Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.

    Infant age 3 months

  • Infant diurnal cortisol production

    Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.

    Infant age 6 months

  • Infant diurnal cortisol production

    Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.

    Infant age 12 months

  • Infant behavioral regulation - Still Face Paradigm

    Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Still Face Paradigm, a mild social stressor.

    Infant age 6 months

  • Infant behavioral regulation - Arm Restraint Task

    Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Arm Restraint Task, a mild stressor.

    Infant age 12 months

  • Infant attachment

    Infant attachment will be assessed using the Strange Situation.

    Infant age 12 months

  • Infant cognitive development

    Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.

    Infant age 3 months

  • Infant motor development

    Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.

    Infant age 3 months

  • Infant social-emotional development

    Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.

    Infant age 3 months

  • Infant cognitive development

    Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.

    Infant age 6 months

  • Infant motor development

    Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.

    Infant age 6 months

  • Infant social-emotional development

    Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.

    Infant age 6 months

  • Infant cognitive development

    Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.

    Infant age 12 months

  • Infant motor development

    Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.

    Infant age 12 months

  • Infant social-emotional development

    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

    Infant social-emotional problems will be assessed through maternal report on the Brief Infant-Toddler Social Emotional Assessment.

    Infant age 12 months

  • Maternal self-efficacy

    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.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal self-efficacy

    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.

    Infant age 12 months

  • Maternal emotion regulation

    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.

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal emotion regulation

    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.

    Infant age 12 months

Secondary Outcomes (25)

  • Maternal substance use - interview

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal substance use - interview

    Infant age 6 months

  • Maternal substance use - interview

    Infant age 12 months

  • Maternal substance use - questionnaire

    Pre-intervention (third trimester of gestation or up to one month postpartum)

  • Maternal substance use - questionnaire

    Infant age 3 months

  • +20 more secondary outcomes

Study Arms (2)

Modified ABC

EXPERIMENTAL

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)

Behavioral: Modified Attachment and Biobehavioral Catch-up

Modified DEF

ACTIVE COMPARATOR

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)

Behavioral: Modified Developmental Education for Families

Interventions

Modified Attachment and Biobehavioral Catch-upBEHAVIORAL

Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.

Also known as: mABC
Modified ABC
Modified Developmental Education for FamiliesBEHAVIORAL

Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.

Also known as: mDEF
Modified DEF

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Related Publications (1)

  • 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.

    PMID: 35748625DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

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
Amy E. du Pont Chair of Child Development

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 27, 2019

Study Start

August 13, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)