Postpartum Intervention for Mothers With Opioid Use Disorders (R33) (PIMO)
Обзор исследования
Статус
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: James E Swain, MD, PhD
- Номер телефона: 516-838-7604
- Электронная почта: james.swain@stonybrookmedicine.edu
Учебное резервное копирование контактов
- Имя: Maria Muzik, MD, MSc
- Номер телефона: 734-846-8027
Места учебы
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- Рекрутинг
- University of Michigan
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Контакт:
- Maria Muzik, MD, MSc
- Номер телефона: 734-846-8027
- Электронная почта: muzik@med.umich.edu
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Контакт:
- Olivia Oates, BA
- Номер телефона: 248-804-2846
- Электронная почта: oolivia@med.umich.edu
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New York
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Stony Brook, New York, Соединенные Штаты, 11794
- Рекрутинг
- Stony Brook University
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Контакт:
- Elle Eggers, BSc
- Номер телефона: 636-667-0135
- Электронная почта: elle.eggers@stonybrookmedicine.edu
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Контакт:
- James E Swain, MD, PhD
- Номер телефона: 5168387604
- Электронная почта: james.swain@stonybrookmedicine.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Mom Power
Mom Power (MP) is an evidence-based 13-session (1/week delivered virtually) psychosocial mother-child intervention with two experienced therapist facilitators that improves sensitive caregiving, parental stress, and depression.
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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 Connection to Resources. MP targets reflective function as a critical parental capacity to infer benevolent and developmentally appropriate meaning underlying a child's behavior during stressful parenting moments, and thus promote each parents' own emotion regulation during such moments. In addition, MP counteracts social isolation by capitalizing on peer group structure with facilitated group activities and tight case management.
Другие имена:
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Активный компаратор: Enhanced Usual Care
Controls participants for the intervention receive 10 weekly mailings, with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources, and general parenting); plus 10 brief check-in phone calls verifying that material was received, and additional longer phone calls to assess any imminent family needs and provide resources as needed/requested.
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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 Connection to Resources. MP targets reflective function as a critical parental capacity to infer benevolent and developmentally appropriate meaning underlying a child's behavior during stressful parenting moments, and thus promote each parents' own emotion regulation during such moments. In addition, MP counteracts social isolation by capitalizing on peer group structure with facilitated group activities and tight case management.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Clinical trial enrollment counts.
Временное ограничение: 3 years
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The number of We plan to enroll/comnent for this clinical trial of Mom Power Intervention vs. Enhanced Usual Care.
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3 years
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Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.
Временное ограничение: 3 years
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Mom Power (MP) and Enhanced Usual Care will be administered to as many participants as possible.
For MP, participants receive a manualized, 12-week group therapy.
For EUC, mothers will recieve 12 weekly mailings with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources), but void of specific MP-related parenting concepts.
Additionally, control mothers receive 12 brief check-in calls verifying that material was received.
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3 years
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Electroencephalography (EEG) Brain Imaging scans counts.
Временное ограничение: 3 years
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We will track the number of participants who complete EEG studies on participants before and after each arm.
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3 years
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Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.
Временное ограничение: 3 years
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We will track fMRI studies on participants before and after each arm.
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3 years
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Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).
Временное ограничение: 3 years
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We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on mood, using the Edinburgh Postnatal Depression Scale (EPDS).
This is a 10-item scale with scores range from 0-30, with higher scores indicating more severe depressive symptoms.
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3 years
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Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).
Временное ограничение: 3 years
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We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on anxiety with the PTSD Checklist for DSM-5 (PCL-5).
This is a 20-item scale ranging from 0-80, with higher scores indicating greater PTSD symptom severity.
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3 years
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Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).
Временное ограничение: 3 years
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We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on parenting stress using the Parenting Stress Index (PSI).
The PSI is a 36-item questionnaire with scores ranging from 0-12 for three subscales: parental distress, parent-child interactions, and perceptions of child behaviors.
Greater scores indicate greater parenting-related stress.
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3 years
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Treatment-related changes in drug craving as assessed by the Opioid Craving Scale (OCS).
Временное ограничение: 3 years
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We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on drug craving using the Opioid Craving Scale (OCS).
This is a 3-item scale.
Higher scores indicate greater opioid craving severity, frequency of cravings, and perceived likelihood of opioid use in response to personal triggers.
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3 years
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Treatment-related changes in N170 and late positive potential (LPP) measures as assessed by Electroencephalography (EEG).
Временное ограничение: 3 years
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We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on EEG response potentials evoked by infant stimuli.
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3 years
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Treatment-related changes in brain activity assessed by functional magnetic resonance imaging (fMRI).
Временное ограничение: 3 years
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We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on the brain, with measures of Blood Oxygenation Level Dependent fMRI signals in response to own infant pictures in the amygdala, hypothalamus and periaqueductal gray.
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3 years
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: James E Swain, MD, PhD, Stony Brook University
Публикации и полезные ссылки
Общие 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Swain JE, Ho SS. Brain circuits for maternal sensitivity and pain involving anterior cingulate cortex among mothers receiving buprenorphine treatment for opioid use disorder. J Neuroendocrinol. 2023 Jul;35(7):e13316. doi: 10.1111/jne.13316. Epub 2023 Jul 25.
- Ho SS, Nakamura Y, Gopang M, Swain JE. Intersubjectivity as an antidote to stress: Using dyadic active inference model of intersubjectivity to predict the efficacy of parenting interventions in reducing stress-through the lens of dependent origination in Buddhist Madhyamaka philosophy. Front Psychol. 2022 Jul 29;13:806755. doi: 10.3389/fpsyg.2022.806755. eCollection 2022.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 4R33DA053688 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Across both Stony Brook Medicine and Michigan Medicine, we will comply with the mission of NIH that findings derived from sponsored research must be shared for the advancement of research. Therefore, we plan to present at scientific meetings and publish in journals, as relevant data become available, so that these data can be readily available to qualified individuals in the scientific and clinical community.
We will maintain a readily accessible but secure documentation of data collected under this grant so that it is accessible to other investigators. As soon as the manuscripts addressing the specific aims of the proposed study are accepted for publication, data sets created in this research program will be made available for other qualified researchers upon request for purposes of scientific scrutiny, research or review. The datasets will be de-identified before distribution.
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .