Postpartum Intervention for Mothers With Opioid Use Disorders (R33) (PIMO)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: James E Swain, MD, PhD
- Telefonnummer: 516-838-7604
- E-post: james.swain@stonybrookmedicine.edu
Studera Kontakt Backup
- Namn: Maria Muzik, MD, MSc
- Telefonnummer: 734-846-8027
Studieorter
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- Rekrytering
- University of Michigan
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Kontakt:
- Maria Muzik, MD, MSc
- Telefonnummer: 734-846-8027
- E-post: muzik@med.umich.edu
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Kontakt:
- Olivia Oates, BA
- Telefonnummer: 248-804-2846
- E-post: oolivia@med.umich.edu
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New York
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Stony Brook, New York, Förenta staterna, 11794
- Rekrytering
- Stony Brook University
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Kontakt:
- Elle Eggers, BSc
- Telefonnummer: 636-667-0135
- E-post: elle.eggers@stonybrookmedicine.edu
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Kontakt:
- James E Swain, MD, PhD
- Telefonnummer: 5168387604
- E-post: james.swain@stonybrookmedicine.edu
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Aktiv komparator: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Clinical trial enrollment counts.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: James E Swain, MD, PhD, Stony Brook University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4R33DA053688 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
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