Intervening With Opioid-Dependent MothersMothers and Infants (mABC)

University of Delaware

Status: Enrolling

Conditions: Parenting; Infant Development; Opioid Dependence

Treatments: Behavioral: mABC; Behavioral: mDEF

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04454645

mABC

1R01HD098525-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Modified ABC

Experimental group

Description:

12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.

Treatment:

Behavioral: mABC

Modified DEF

Active Comparator group

Description:

12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development

Treatment:

Behavioral: mDEF