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Intervening With Opioid-Dependent MothersMothers and Infants
NCT04454645 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL mABC
- BEHAVIORAL mDEF
Study Locations (1)
Delaware
- University of Delaware — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04454645
The ClinicalTrials.gov registry entry for NCT04454645 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Delaware, which has 159 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Parenting appearing as the primary indexed condition, and to 2 interventions — of which mABC is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04454645 reports 1 study location spanning 1 distinct geographic area — top geographies include Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04454645 about?
NCT04454645 is a clinical study titled "Intervening With Opioid-Dependent MothersMothers and Infants". 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 Biobeh...
What is the current status of trial NCT04454645?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2020-05-01. Estimated completion is 2026-03-31.
What conditions does trial NCT04454645 study?
This clinical trial studies the following conditions: Parenting, Infant Development, Opioid Dependence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04454645?
The interventions under investigation include: mABC (BEHAVIORAL), mDEF (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04454645?
This trial is sponsored by University of Delaware, which has 159 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04454645 being conducted?
This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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