Recruiting

vMP & EUC

Sponsor:

Stony Brook University

Code:

NCT07632053

Conditions

Opioid Use Disorder

Parent-Child Relations

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Mom Power

Study Details

Brief summary:

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.

Conditions

Opioid Use Disorder

Parent-Child Relations

Study ID

NCT07632053

Start date

Jul 1, 2025

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

James E Swain, MD, PhD

516-838-7604james.swain@stonybrookmedicine.edu

Maria Muzik, MD, MSc

734-846-8027

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Maria Muzik, MD, MSc

734-846-8027muzik@med.umich.edu

Olivia Oates, BA

248-804-2846oolivia@med.umich.edu

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

Contacts

James E Swain, MD, PhD

5168387604james.swain@stonybrookmedicine.edu

Elle Eggers, BSc

636-667-0135elle.eggers@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • parenting intervention
  • opioid use disorder
  • parental stress
  • maternal brain
  • evoked response potentials
  • brain fMRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-06-09.