Postpartum Intervention for Mothers With Opioid Use Disorders (R33)

Обзор

Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=\~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.

Подробное описание

Informed by the results from the R61 phase, we have fine-tuned the exact hypotheses as follows:

Post-intervention, mothers with OUD randomized to receive MP, compared to control group of enhanced usual care (EUC), will exhibit Hypothesis (a) - lower Evoked Response Potential (ERP) responses to infant's crying and Hypothesis (b) - normalized fMRI-assessed brain activity in key MBN regions, e.g., hypothalamus, amygdala and periaqueductal gray. Hypothesis (c) The pre-to-post improvements in mothers' drug craving, mood and parental stress will be greater for mothers in the vMP vs. EUC conditions.

Hypothesis (d) Assuming Ha-c are confirmed, we will test whether the clinical benefits of vMP are mediated through vMP-induced changes in the MBN.

Вмешательства

• Поведенческое Mom Power
  Experimental participants will receive virtual Mom Power via phone/internet connection. Mom Power (MP), rooted in attachment theory and trauma-informed clinical work is an evidence-based, manualized, 13-session (10 group + 3 individual) intervention delivered across 12-weeks. The manualized intervention rests on five core components paralleling the Strengthening Families/Protective Factors Framework: Parenting Education; Self-Care; Guided Parent-Child Interactions; Social Support; and Connectio

Первичные конечные точки

• Clinical trial enrollment counts. [Срок оценки: 3 years]
• Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts. [Срок оценки: 3 years]
• Electroencephalography (EEG) Brain Imaging scans counts. [Срок оценки: 3 years]
• Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC. [Срок оценки: 3 years]
• Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS). [Срок оценки: 3 years]
• Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5). [Срок оценки: 3 years]
• Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI). [Срок оценки: 3 years]
• Treatment-related changes in drug craving as assessed by the Opioid Craving Scale (OCS). [Срок оценки: 3 years]
• Treatment-related changes in N170 and late positive potential (LPP) measures as assessed by Electroencephalography (EEG). [Срок оценки: 3 years]
• Treatment-related changes in brain activity assessed by functional magnetic resonance imaging (fMRI). [Срок оценки: 3 years]

Критерии участия

Критерии включения

• mothers with diagnosis of Opioid Use Disorder (OUD); and/or receiving medication assisted treatment (such as buprenorphine or methadone)
• with a child aged 5 or less
• able to read, hear and understand English adequately enough to provide informed consent

Критерии исключения

• require immediate clinical care for suicidal/homicidal risk or psychosis;
• For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they: (1) have ferromagnetic metal in their heads (2) have severe claustrophobia that prevents participation in the neuroimaging (3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Michigan — Ann Arbor
• Stony Brook University — Stony Brook

Публикации

• Rosenblum K, Lawler J, Alfafara E, Miller N, Schuster M, Muzik M. Improving Maternal Representations in High-Risk Mothers: A Randomized, Controlled Trial of the Mom Power Parenting Intervention. Child Psychiatry Hum Dev. 2018 Jun;49(3):372-384. doi: 10.1007/s10578-017-0757-5. PMID 28936602
• Muzik M, Rosenblum KL, Alfafara EA, Schuster MM, Miller NM, Waddell RM, Stanton Kohler E. Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. Arch Womens Ment Health. 2015 Jun;18(3):507-21. doi: 10.1007/s00737-014-0490-z. Epub 2015 Jan 11. PMID 25577336
• Ho SS, Muzik M, Rosenblum KL, Morelen D, Nakamura Y, Swain JE. Potential Neural Mediators of Mom Power Parenting Intervention Effects on Maternal Intersubjectivity and Stress Resilience. Front Psychiatry. 2020 Dec 8;11:568824. doi: 10.3389/fpsyt.2020.568824. eCollection 2020. PMID 33363481
• Swain JE, Ho SS, Rosenblum KL, Morelen D, Dayton CJ, Muzik M. Parent-child intervention decreases stress and increases maternal brain activity and connectivity during own baby-cry: An exploratory study. Dev Psychopathol. 2017 May;29(2):535-553. doi: 10.1017/S0954579417000165. PMID 28401845
• Swain JE, Ho SS, Fox H, Garry D, Brummelte S. Effects of opioids on the parental brain in health and disease. Front Neuroendocrinol. 2019 Jul;54:100766. doi: 10.1016/j.yfrne.2019.100766. Epub 2019 May 22. PMID 31128130
• Swain JE, Ho SS. Early postpartum resting-state functional connectivity for mothers receiving buprenorphine treatment for opioid use disorder: A pilot study. J Neuroendocrinol. 2019 Sep;31(9):e12770. doi: 10.1111/jne.12770. Epub 2019 Jul 29. PMID 31287922
• Swain JE, Ho SS. Opioids and maternal brain-behavior adaptation. Neuropsychopharmacology. 2021 Jan;46(1):265-266. doi: 10.1038/s41386-020-00858-7. No abstract available. PMID 32913343
• Swain JE, Ho SS. Reduced Child-Oriented Face Mirroring Brain Responses in Mothers With Opioid Use Disorder: An Exploratory Study. Front Psychol. 2022 Feb 4;12:770093. doi: 10.3389/fpsyg.2021.770093. eCollection 2021. PMID 35185679

Идентификаторы

NCT: NCT07632053 · 4R33DA053688

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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