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Completed

NCT Number: NCT03891628

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

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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Infant Development Mental Disorders Narcotic-Related Disorders Parent-Child Relations Parenting Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Modified Attachment and Biobehavioral Catch-up

Behavioral

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

Other names: mABC

Modified Developmental Education for Families

Behavioral

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

Other names: mDEF

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Maternal sensitivity

    Time frame: Infant age 12 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.

  5. Maternal methylation of μ-opioid receptor (OPRM1) gene

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

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

  6. 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.

  7. 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.

  8. Maternal methylation of μ-opioid receptor (OPRM1) gene

    Time frame: Infant age 12 months

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

  9. Maternal methylation of oxytocin receptor (OXTR) gene

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

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

  10. Maternal methylation of oxytocin receptor (OXTR) gene

    Time frame: Infant age 3 months

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

  11. Maternal methylation of oxytocin receptor (OXTR) gene

    Time frame: Infant age 6 months

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

  12. 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.

  13. Infant methylation of μ-opioid receptor (OPRM1) gene

    Time frame: Infant age 3 months

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

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Maternal neural activity (EEG) - Own child-other child task

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

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

  20. Maternal neural activity (EEG) - Own child-other child task

    Time frame: Infant age 12 months

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

  21. Maternal neural activity (EEG) - Reward sensitivity task

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

    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.

  22. Maternal neural activity (EEG) - Reward sensitivity task

    Time frame: Infant age 12 months

    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.

  23. Maternal neural activity (EEG) - Child emotion task

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

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

  24. Maternal neural activity (EEG) - Child emotion task

    Time frame: Infant age 12 months

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

  25. Maternal parasympathetic nervous system activity

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

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

  26. Maternal sympathetic nervous system activity

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

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

  27. Maternal parasympathetic nervous system activity

    Time frame: Infant age 3 months

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

  28. Maternal sympathetic nervous system activity

    Time frame: Infant age 3 months

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

  29. Maternal parasympathetic nervous system activity

    Time frame: Infant age 6 months

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

  30. Maternal sympathetic nervous system activity

    Time frame: Infant age 6 months

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

  31. Maternal parasympathetic nervous system activity

    Time frame: Infant age 12 months

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

  32. Maternal sympathetic nervous system activity

    Time frame: Infant age 12 months

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

  33. Infant parasympathetic nervous system activity

    Time frame: Infant age 3 months

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

  34. Infant sympathetic nervous system activity

    Time frame: Infant age 3 months

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

  35. Infant parasympathetic nervous system activity

    Time frame: Infant age 6 months

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

  36. Infant sympathetic nervous system activity

    Time frame: Infant age 6 months

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

  37. Infant parasympathetic nervous system activity

    Time frame: Infant age 12 months

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

  38. Infant sympathetic nervous system activity

    Time frame: Infant age 12 months

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

  39. Maternal diurnal cortisol production

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

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

  40. Maternal diurnal cortisol production

    Time frame: Infant age 12 months

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

  41. Infant diurnal cortisol production

    Time frame: Infant age 3 months

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

  42. Infant diurnal cortisol production

    Time frame: Infant age 6 months

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

  43. Infant diurnal cortisol production

    Time frame: Infant age 12 months

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

  44. Infant behavioral regulation - Still Face Paradigm

    Time frame: Infant age 6 months

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

  45. Infant behavioral regulation - Arm Restraint Task

    Time frame: Infant age 12 months

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

  46. Infant attachment

    Time frame: Infant age 12 months

    Infant attachment will be assessed using the Strange Situation.

  47. Infant cognitive development

    Time frame: Infant age 3 months

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

  48. Infant motor development

    Time frame: Infant age 3 months

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

  49. Infant social-emotional development

    Time frame: Infant age 3 months

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

  50. Infant cognitive development

    Time frame: Infant age 6 months

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

  51. Infant motor development

    Time frame: Infant age 6 months

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

  52. 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.

  53. Infant cognitive development

    Time frame: Infant age 12 months

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

  54. Infant motor development

    Time frame: Infant age 12 months

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

  55. 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.

  56. 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.

  57. Maternal self-efficacy

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

    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.

  58. Maternal self-efficacy

    Time frame: Infant age 12 months

    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.

  59. 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.

  60. 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.

Secondary outcomes

  1. 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.

  2. Maternal substance use - interview

    Time frame: Infant age 6 months

    The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.

  3. Maternal substance use - interview

    Time frame: Infant age 12 months

    The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.

  4. Maternal substance use - questionnaire

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

    Mothers will report their history of substance use using the NIDA ASSIST questionnaire.

  5. Maternal substance use - questionnaire

    Time frame: Infant age 3 months

    Mothers will report recent substance use using the NIDA Quick Screen questionnaire.

  6. Maternal substance use - questionnaire

    Time frame: Infant age 6 months

    Mothers will report recent substance use using the NIDA Quick Screen questionnaire.

  7. Maternal substance use - questionnaire

    Time frame: Infant age 12 months

    Mothers will report recent substance use using the NIDA Quick Screen questionnaire.

  8. Maternal depressive symptoms

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

    Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.

  9. Maternal depressive symptoms

    Time frame: Infant age 3 months

    Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.

  10. Maternal depressive symptoms

    Time frame: Infant age 6 months

    Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.

  11. Maternal depressive symptoms

    Time frame: Infant age 12 months

    Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.

  12. Infant physical growth

    Time frame: Infant age 3 months

    Infant physical growth will be assessed using weight, length, and head circumference.

  13. Infant physical growth

    Time frame: Infant age 6 months

    Infant physical growth will be assessed using weight, length, and head circumference.

  14. Infant physical growth

    Time frame: Infant age 12 months

    Infant physical growth will be assessed using weight, length, and head circumference.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Maternal sleep

    Time frame: Infant age 3 months

    Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.

  21. Maternal sleep

    Time frame: Infant age 6 months

    Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.

  22. Maternal sleep

    Time frame: Infant age 12 months

    Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.

  23. Infant sleep

    Time frame: Infant age 3 months

    Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.

  24. Infant sleep

    Time frame: Infant age 6 months

    Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.

  25. Infant sleep

    Time frame: Infant age 12 months

    Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

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

Acronym: mABC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2019
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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