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NCT03891628 · ClinicalTrials.gov registry record · NA
Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants
A NA study, sponsored by University of Delaware.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT03891628: Completed NA study, sponsored by University of Delaware.
NCT03891628 is a NA study that has completed, run by University of Delaware. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03891628, a NA study, has completed, sponsored by University of Delaware.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Maternal sensitivity will be coded observationally from maternal interactions with an infant simulator pre-programmed to coo and then cry. Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic. Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting.
Interventions
- BEHAVIORAL Modified Attachment and Biobehavioral Catch-up
- BEHAVIORAL Modified Developmental Education for Families
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2021-03-31 |
| Phase | NA |
What the finished NCT03891628 record still lists
NCT03891628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Modified Attachment and Biobehavioral Catch-up is the first listed.
NCT03891628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03891628 about?
NCT03891628 is a clinical study titled "Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants". 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...
What is the current status of trial NCT03891628?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2018-08-13. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT03891628?
The interventions under investigation include: Modified Attachment and Biobehavioral Catch-up (BEHAVIORAL), Modified Developmental Education for Families (BEHAVIORAL).
Who is sponsoring clinical trial NCT03891628?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03891628's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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