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Intervening With Opioid-Dependent MothersMothers and Infants (mABC)

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ClinicalTrials.gov Identifier: NCT04454645
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mary Dozier, University of Delaware

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Parenting Infant Development Behavioral: mABC Behavioral: mDEF Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Modified ABC
12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
Behavioral: mABC
Intervention targets parenting sensitivity and nurturance.

Active Comparator: Modified DEF
12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development
Behavioral: mDEF
Intervention targets parenting enhancing infant cognitive development




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454645


Contacts
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Contact: Mary Dozier, Ph.D. 3028312286 mdozier@udel.edu

Locations
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United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19716
Principal Investigator: Mary Dozier, PhD         
Sponsors and Collaborators
University of Delaware
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Mary Dozier, Ph.D. University of Delaware
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Responsible Party: Mary Dozier, Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT04454645    
Other Study ID Numbers: mABC
1R01HD098525-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders