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NCT03891628: mABC

Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants

Completed NA Last updated 1 September 2021
What this trial tests

NA trial testing Modified Attachment and Biobehavioral Catch-up in Opioid-Related Disorders in 65 participants. Completed in 31 March 2021.

Timeline
13 August 2018
Primary endpoint
31 March 2021
31 March 2021

Quick facts

Lead sponsorUniversity of Delaware
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment65
Start date13 August 2018
Primary completion31 March 2021
Estimated completion31 March 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. Prenatal Substance Exposure.
    Eiden RD, Perry KJ, Ivanova MY, Marcus RC. · · 2023 · cited 13× · PMID 40874035 · DOI 10.1146/annurev-devpsych-120621-043414
  3. 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
  4. 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
  5. 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
  6. 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:

Other recruiting trials for Opioid-Related Disorders

Currently open trials in the same condition.

Other University of Delaware trials

Trials by the same sponsor.

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Data sources for this page

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