Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Postpartum Intervention for Mothers With Opioid Use Disorders (R33) (PIMO)

3. Juni 2026 aktualisiert von: James Edward Swain, Stony Brook University
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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Maria Muzik, MD, MSc
  • Telefonnummer: 734-846-8027

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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 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.

Andere Namen:
  • Parenting Intervention
Aktiver 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.
Verhalten: 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 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.

Andere Namen:
  • Parenting Intervention

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical trial enrollment counts.
Zeitfenster: 3 years
The number of We plan to enroll/comnent for this clinical trial of Mom Power Intervention vs. Enhanced Usual Care.
3 years
Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.
Zeitfenster: 3 years
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.
3 years
Electroencephalography (EEG) Brain Imaging scans counts.
Zeitfenster: 3 years
We will track the number of participants who complete EEG studies on participants before and after each arm.
3 years
Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.
Zeitfenster: 3 years
We will track fMRI studies on participants before and after each arm.
3 years
Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).
Zeitfenster: 3 years
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.
3 years
Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).
Zeitfenster: 3 years
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.
3 years
Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).
Zeitfenster: 3 years
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.
3 years
Treatment-related changes in drug craving as assessed by the Opioid Craving Scale (OCS).
Zeitfenster: 3 years
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.
3 years
Treatment-related changes in N170 and late positive potential (LPP) measures as assessed by Electroencephalography (EEG).
Zeitfenster: 3 years
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.
3 years
Treatment-related changes in brain activity assessed by functional magnetic resonance imaging (fMRI).
Zeitfenster: 3 years
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.
3 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stony Brook University

Mitarbeiter

University of Michigan

Ermittler

  • Hauptermittler: James E Swain, MD, PhD, Stony Brook University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2025

Primärer Abschluss (Geschätzt)

30. Juni 2028

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

16. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 4R33DA053688 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

This trial is currently anticipated to end 6/30/28. Publications addressing the primary aims will require approximately 1-3 years.

IPD-Sharing-Zugriffskriterien

Deidentified 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. We will use a formal signed data-use agreement including information about the investigator's name, affiliation, address, telephone number, FAX number and e-mail address. Interested investigators will also be asked to submit their plan for analysis with the request so that the original informed consent stipulations can be honored. The cost of data retrieval and secure transfer may be requested of the investigator.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Eltern-Kind-Beziehungen

Klinische Studien zur Mom Power

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Nigeria

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren