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mABC Intervention for Opioid Addiction (mABC Trial)

N/A
Recruiting
Led By Mary Dozier, Ph.D.
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up infant age of 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if the mABC Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder, is more effective than a control intervention in improving parenting and infant outcomes.

Who is the study for?
This trial is for opioid-dependent pregnant women in their third trimester who are on medication-assisted treatment. There are no specific exclusion criteria listed, so it may be open to a wide range of individuals within this group.
What is being tested?
The study is testing the effectiveness of a parenting intervention called modified Attachment and Biobehavioral Catch-Up (mABC) for mothers with opioid use disorder. It aims to improve nurturing behavior and emotional regulation in both mothers and infants compared to a control group receiving standard care.
What are the potential side effects?
Since mABC is a behavioral intervention rather than a medical drug, there aren't typical side effects like you'd expect from medication. However, participants might experience emotional discomfort or stress during therapy sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~infant age of 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and infant age of 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Infant attachment
Infant behavioral regulation
Infant cognitive development
+11 more
Secondary study objectives
Maternal depression
Maternal executive functioning
Maternal substance use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Modified ABCExperimental Treatment1 Intervention
12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
Group II: Modified DEFActive Control1 Intervention
12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,686 Total Patients Enrolled
24 Trials studying Parenting
6,988 Patients Enrolled for Parenting
University of DelawareLead Sponsor
161 Previous Clinical Trials
25,476 Total Patients Enrolled
1 Trials studying Parenting
65 Patients Enrolled for Parenting
Mary Dozier, Ph.D.Principal Investigator - University of Delaware
University of Delaware
4 Previous Clinical Trials
780 Total Patients Enrolled

Media Library

mABC Clinical Trial Eligibility Overview. Trial Name: NCT04454645 — N/A
Parenting Research Study Groups: Modified ABC, Modified DEF
Parenting Clinical Trial 2023: mABC Highlights & Side Effects. Trial Name: NCT04454645 — N/A
mABC 2023 Treatment Timeline for Medical Study. Trial Name: NCT04454645 — N/A
~46 spots leftby Mar 2026
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