Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants

Opioid-Related Disorders Clinical Trial

— mABC  

Official title:

Modified Attachment and Biobehavioral Catch-Up for Mothers and Their Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891628
• Other study ID #: PSYC412125
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2021
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In third trimester of pregnancy or up to one month postpartum

• Receiving medication-assisted treatment for opioid use disorder

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infant Development
• Opioid-Related Disorders
• Parent-Child Relations
• Parenting

Intervention

Behavioral:
• Modified Attachment and Biobehavioral Catch-up
Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.
• Modified Developmental Education for Families
Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	Maternal parasympathetic nervous system activity	Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.	Infant age 3 months
Primary	Maternal sympathetic nervous system activity	Maternal sympathetic nervous system activity will be assessed using pre-ejection period.	Infant age 3 months
Primary	Maternal parasympathetic nervous system activity	Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.	Infant age 6 months
Primary	Maternal sympathetic nervous system activity	Maternal sympathetic nervous system activity will be assessed using pre-ejection period.	Infant age 6 months
Primary	Maternal parasympathetic nervous system activity	Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.	Infant age 12 months
Primary	Maternal sympathetic nervous system activity	Maternal sympathetic nervous system activity will be assessed using pre-ejection period.	Infant age 12 months
Primary	Infant parasympathetic nervous system activity	Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.	Infant age 3 months
Primary	Infant sympathetic nervous system activity	Infant sympathetic nervous system activity will be assessed using pre-ejection period.	Infant age 3 months
Primary	Infant parasympathetic nervous system activity	Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.	Infant age 6 months
Primary	Infant sympathetic nervous system activity	Infant sympathetic nervous system activity will be assessed using pre-ejection period.	Infant age 6 months
Primary	Infant parasympathetic nervous system activity	Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.	Infant age 12 months
Primary	Infant sympathetic nervous system activity	Infant sympathetic nervous system activity will be assessed using pre-ejection period.	Infant age 12 months
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Infant attachment	Infant attachment will be assessed using the Strange Situation.	Infant age 12 months
Primary	Infant cognitive development	Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.	Infant age 3 months
Primary	Infant motor development	Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.	Infant age 3 months
Primary	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
Primary	Infant cognitive development	Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.	Infant age 6 months
Primary	Infant motor development	Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.	Infant age 6 months
Primary	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
Primary	Infant cognitive development	Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.	Infant age 12 months
Primary	Infant motor development	Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.	Infant age 12 months
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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	Maternal substance use - interview	The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.	Pre-intervention (third trimester of gestation or up to one month postpartum)
Secondary	Maternal substance use - interview	The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.	Infant age 6 months
Secondary	Maternal substance use - interview	The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.	Infant age 12 months
Secondary	Maternal substance use - questionnaire	Mothers will report their history of substance use using the NIDA ASSIST questionnaire.	Pre-intervention (third trimester of gestation or up to one month postpartum)
Secondary	Maternal substance use - questionnaire	Mothers will report recent substance use using the NIDA Quick Screen questionnaire.	Infant age 3 months
Secondary	Maternal substance use - questionnaire	Mothers will report recent substance use using the NIDA Quick Screen questionnaire.	Infant age 6 months
Secondary	Maternal substance use - questionnaire	Mothers will report recent substance use using the NIDA Quick Screen questionnaire.	Infant age 12 months
Secondary	Maternal depressive symptoms	Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.	Pre-intervention (third trimester of gestation or up to one month postpartum)
Secondary	Maternal depressive symptoms	Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.	Infant age 3 months
Secondary	Maternal depressive symptoms	Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.	Infant age 6 months
Secondary	Maternal depressive symptoms	Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.	Infant age 12 months
Secondary	Infant physical growth	Infant physical growth will be assessed using weight, length, and head circumference.	Infant age 3 months
Secondary	Infant physical growth	Infant physical growth will be assessed using weight, length, and head circumference.	Infant age 6 months
Secondary	Infant physical growth	Infant physical growth will be assessed using weight, length, and head circumference.	Infant age 12 months
Secondary	Maternal experiences during labor and delivery	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.	Infant age 3 months
Secondary	Home environment	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.	Infant age 3 months
Secondary	Maternal reward responsiveness	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.	Pre-intervention (third trimester of gestation or up to one month postpartum)
Secondary	Maternal reward responsiveness	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
Secondary	Maternal sleep	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)
Secondary	Maternal sleep	Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.	Infant age 3 months
Secondary	Maternal sleep	Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.	Infant age 6 months
Secondary	Maternal sleep	Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.	Infant age 12 months
Secondary	Infant sleep	Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.	Infant age 3 months
Secondary	Infant sleep	Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.	Infant age 6 months
Secondary	Infant sleep	Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.	Infant age 12 months