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NCT03891628: mABC
Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants
NA trial testing Modified Attachment and Biobehavioral Catch-up in Opioid-Related Disorders in 65 participants. Completed in 31 March 2021.
31 March 2021
Quick facts
| Lead sponsor | University of Delaware |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 65 |
| Start date | 13 August 2018 |
| Primary completion | 31 March 2021 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Modified Attachment and Biobehavioral Catch-up
- Modified Developmental Education for Families
Conditions studied
- Opioid-Related Disorders — all drugs for Opioid-Related Disorders →
- Parent-Child Relations — all drugs for Parent-Child Relations →
- Infant Development — all drugs for Infant Development →
- Parenting — all drugs for Parenting →
Sponsor
University of Delaware
Who can join
18 and older, female only, with Opioid-Related Disorders or Parent-Child Relations. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Infant neurodevelopmental outcomes of prenatal opioid exposure and polysubstance use.
Labella MH, Eiden RD, Tabachnick AR, Sellers T, et al · · 2021 · cited 16× · PMID 34116198 · DOI 10.1016/j.ntt.2021.107000 -
Prenatal Substance Exposure.
Eiden RD, Perry KJ, Ivanova MY, Marcus RC. · · 2023 · cited 13× · PMID 40874035 · DOI 10.1146/annurev-devpsych-120621-043414 -
Effects of an attachment-based intervention on autonomic regulation among opioid-exposed infants.
Tabachnick AR, Eiden RD, Labella MH, Dozier M. · · 2022 · cited 4× · PMID 35748625 · DOI 10.1002/dev.22286 -
Emotion dysregulation and reward responsiveness as predictors of autonomic reactivity to an infant cry task among substance-using pregnant and postpartum women.
Bounoua N, Tabachnick AR, Eiden RD, Labella MH, et al · · 2024 · cited 1× · PMID 38131244 · DOI 10.1002/dev.22449 -
Effects of prenatal opioid exposure on infant sympathetic and parasympathetic nervous system activity.
Tabachnick AR, Eiden RD, Labella MH, Dozier M. · · 2024 · cited 1× · PMID 37888142 · DOI 10.1111/psyp.14470 -
A 12-month follow-up of infant neurodevelopmental outcomes of prenatal opioid exposure and polysubstance use.
Bierce L, Tabachnick AR, Eiden RD, Dozier M, et al · · 2023 · cited 1× · PMID 37054901 · DOI 10.1016/j.ntt.2023.107176
Verify or expand the search:
- PubMed search for NCT03891628
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03891628 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Delaware
- Last refreshed: 1 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03891628.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing