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

University of Delaware

Status: Completed

Conditions: Parenting; Opioid-Related Disorders; Parent-Child Relations; Infant Development

Treatments: Behavioral: Modified Developmental Education for Families; Behavioral: Modified Attachment and Biobehavioral Catch-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03891628

PSYC412125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• In third trimester of pregnancy or up to one month postpartum
• Receiving medication-assisted treatment for opioid use disorder

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

Modified ABC

Experimental group

Description:

Modified Attachment and Biobehavioral Catch-Up (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits)

Treatment:

Behavioral: Modified Attachment and Biobehavioral Catch-up

Modified DEF

Active Comparator group

Description:

Modified Developmental Education for Families (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits)

Treatment:

Behavioral: Modified Developmental Education for Families