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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

mABC Trial 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.Check my eligibility

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.See study design

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.

mABC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ infant age of 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Infant attachment

Infant behavioral regulation

Infant cognitive development

+11 more

Secondary outcome measures

Maternal depression

Maternal executive functioning

Maternal substance use

mABC 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,597 Total Patients Enrolled

University of DelawareLead Sponsor

154 Previous Clinical Trials

25,011 Total Patients Enrolled

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

Opioid Addiction Research Study Groups: Modified ABC, Modified DEF

Opioid Addiction Clinical Trial 2023: mABC Highlights & Side Effects. Trial Name: NCT04454645 — N/A

mABC 2023 Treatment Timeline for Medical Study. Trial Name: NCT04454645 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for involvement in this research?

"To be considered for inclusion in this trial, prospective participants must possess parentage and fall within the ages 18 to 70. This clinical investigation is looking to recruit a total of 200 individuals."

Answered by AI

Is this evaluation currently enrolling participants?

"Affirmative. The clinicaltrial.gov page reveals that the first posting of this study was dated 5/1/2020, and it is still currently seeking 200 participants from 1 sites."

Answered by AI

How many participants have voluntarily signed up for this clinical experiment?

"Affirmative. Per the information listed on clinicaltrials.gov, this medical study is still actively searching for participants and was initially published on May 1st 2020. The trial requires 200 enrollees from a single location to be admitted into it."

Answered by AI