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Completed

NCT Number: NCT04454645

Intervening With Opioid-Dependent MothersMothers and Infants

This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) 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 than infants of parents who receive the control intervention.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

Pregnant 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 mABC 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 mABC 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 mABC intervention on improved infant outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment

Exclusion criteria

  • None

Treatment and study plan

mABC

Behavioral

Intervention targets parenting sensitivity and nurturance.

mDEF

Behavioral

Intervention targets parenting enhancing infant cognitive development

Primary outcomes

  1. Maternal sensitivity

    Time frame: Pre-intervention (3rd trimester)

    The mother will be assessed interacting with the infant simulator. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.

  2. Maternal sensitivity

    Time frame: Infant age of 3 months

    The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.

  3. Maternal sensitivity

    Time frame: Infant age of 6 months

    The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.

  4. Maternal sensitivity

    Time frame: Infant age of 12 months

    The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.

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

    Time frame: Pre-intervention (3rd trimester)

    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 of 12 months

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

  7. Maternal methylation of oxytocin receptor (OXTR) gene

    Time frame: Pre-intervention (3rd trimester)

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

  8. Maternal methylation of oxytocin receptor (OXTR) gene

    Time frame: Infant age of 12 months

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

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

    Time frame: Pre-intervention (3rd trimester)

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

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

    Time frame: Infant age of 12 months

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

  11. Maternal neural activity (Event related potentials - ERP) - Own child-other child task

    Time frame: Pre-intervention (3rd trimester)

    Maternal event-related potentials (ERP) will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.

  12. Maternal neural activity (Event related potentials - ERP) - Own child-other child task

    Time frame: Infant age of 12 months

    Maternal event-related potentials will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.

  13. Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task

    Time frame: Pre-intervention (3rd trimester)

    Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.

  14. Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task

    Time frame: Infant age of 12 months

    Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.

  15. Maternal neural activity (Event related potentials - ERP) - Child emotion task

    Time frame: Pre-intervention (3rd trimester)

    Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.

  16. Maternal neural activity (Event related potentials - ERP) - Child emotion task

    Time frame: Infant age of 12 months

    Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.

  17. Maternal parasympathetic nervous system activity during Still Face

    Time frame: Pre-intervention (3rd trimester)

    The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.

  18. Maternal parasympathetic nervous system activity

    Time frame: Infant age of 12 months

    The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.

  19. Infant parasympathetic nervous system activity

    Time frame: Infant age of 6 months

    The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.

  20. Infant parasympathetic nervous system activity

    Time frame: Infant age of 12 months

    The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.

  21. Infant diurnal cortisol production

    Time frame: Infant age of 6 months

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

  22. Infant diurnal cortisol production

    Time frame: Infant age of 12 months

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

  23. Infant behavioral regulation

    Time frame: Infant age of 6 months

    Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).

  24. Infant behavioral regulation

    Time frame: Infant age of 12 months

    Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).

  25. Infant attachment

    Time frame: Infant age of 12 months

    Infant attachment will be assessed using the Strange Situation. Coding will be completed using the standard Strange Situation coding scheme (with 4 major categories, with secure preferable).

  26. Infant cognitive development

    Time frame: Infant age of 12 months

    Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. Scores could range from 0-300 with higher scores reflecting higher functioning.

Secondary outcomes

  1. Maternal substance use

    Time frame: Pre-intervention (3rd trimester)

    Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).

  2. Maternal substance use

    Time frame: Infant age of 12 months

    Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).

  3. Maternal depression

    Time frame: Pre-intervention (3rd trimester)

    Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)

  4. Maternal depression

    Time frame: Infant age of 12 months

    Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)

  5. Maternal executive functioning

    Time frame: Pre-intervention (3rd trimester)

    Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.

  6. Maternal executive functioning

    Time frame: Infant age of 12 months

    Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation

Acronym: mABC

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2020
Registry last updated
May 5, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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