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NCT04454645 · ClinicalTrials.gov registry record · NA
Intervening With Opioid-Dependent MothersMothers and Infants
A NA study of Parenting and Infant Development, sponsored by University of Delaware.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04454645: Recruiting NA study of Parenting and Infant Development, sponsored by University of Delaware.
NCT04454645 is a NA study of Parenting and Infant Development that is actively recruiting participants, run by University of Delaware. The registered enrollment target is 200 participants, below the 645-participant average among 66 other Parenting trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04454645, a NA study of Parenting and Infant Development, is actively recruiting participants, sponsored by University of Delaware.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The mother will be assessed interacting with the infant simulator. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
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 |
What NCT04454645 shows while recruiting
NCT04454645 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 645-participant average among 66 other Parenting trials with a reported enrollment target (69% lower).
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.
NCT04454645 reports a single indexed study location in Delaware.
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.
What interventions are being tested in trial NCT04454645?
The interventions under investigation include: mABC (BEHAVIORAL), mDEF (BEHAVIORAL).
Who is sponsoring clinical trial NCT04454645?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Parenting
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04454645's enrollment target sits among peer trials
200 34th of 66 higher than 32 of 66 other Parenting trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parenting trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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