Intervening With Opioid-Dependent MothersMothers and Infants

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    200
  • sponsor
    University of Delaware
Updated on 19 February 2024
opioid
narcotic use
opioid use disorder

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.

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.

Details
Condition Parenting, Drug abuse, substance abuse, Child Development, Opioid Dependence, Opioid Use Disorder, Opioid Use Disorder, substance abuse
Age 18years - 89years
Treatment mABC, mDEF
Clinical Study IdentifierNCT04454645
SponsorUniversity of Delaware
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

None
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