NCT03891628

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Delaware · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	Modified Developmental Education for Families	Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.

Timeline

• Start date: 2018-08-13
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-03-27
• Last updated: 2021-09-01

Locations

1 site across 1 country: United States