Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT05495984

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: Female

Age: 21 - 45

Healthy Volunteers: Not accepted

Interventions

ERPs with electroencephalography (EEG)

MIO

Study Details

Brief summary:

Opioid use disorder (OUD) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. The perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. OUD is also associated with neural reorganization, specifically neural circuitry implicated in stress regulation and reward processes. Interventions should therefore take advantage of this changing perinatal biology to enhance treatment response by targeting the aberrant neural circuitry compromised by maternal OUD. The investigators have developed and refined an evidence-based intervention for mothers with OUD designed to target these neural mechanisms and enhance the reward of caregiving; however, this has yet to be formally tested. Therefore, the investigators will examine maternal neuroplasticity using high-dense array electroencephalography (EEG) in mothers with OUD in response to our intervention. There will be 1 laboratory visit at pre-treatment, followed by 12 sessions of the evidence-based parenting intervention, and 1 laboratory visit at post-treatment. This study will attempt to validate the importance of taking advantage of the neuroplasticity in the perinatal period to optimize outcomes for mothers with OUD.

Conditions

Opioid Use Disorder

Study ID

NCT05495984

Start date

Jan 1, 2023

Status verified date

Oct, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Biological mother of infants between 4-months and 12-months of age
  • 21-45 years of age at time of recruitment
  • Enrolled in substance use treatment and on mediation for opioid use disorder (MOUD).

Exclusion Criteria:

  • Incapable of giving informed consent
  • Child spends less than 50% of time in mother's custody.
  • Non-English-speaking
  • Unable to complete the study because of pending legal cases or unable to supply two forms of contact for the purpose of follow-up
  • Physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea).

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Primary Objective: Event-Related Potentials (ERPs)

Use ERPs elicited by unknown infant face and cry stimuli to determine whether neural markers translate to maternal mentalization in mothers with opioid use disorder (OUD) at 4-12 months postpartum

experimental: Secondary Objective: ERPs + Mothering from the Inside Out (MIO)

Use Event-Related Potentials (ERPs) elicited by unknown infant face and cry stimuli to determine whether neural response changes with participation in an evidence-based parenting intervention designed specifically for mothers with OUD: Mothering from the Inside Out (MIO).

Interventions

ERPs with electroencephalography (EEG)

E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes (ERPs). Visual stimuli will include photographs of color photographs of unfamiliar infants (aged 5- 10 months) balanced for ethnicity (Black/White) and gender (male/female) displaying happy neutral, and sad affective expressions. Auditory stimuli will include 2-second audio clips of high-distress and low-distress infant cries. Experimental procedure: Trials will consist of a central fixation cross (jittered 400-600ms), stimulus presentation (500ms faces, 2000ms cries), and blank screen (1000ms). Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. A 128 Ag/Silver Chloride (AgCl) electrode net will be soaked in a warm potassium chloride solution, and net electrodes will be spaced evenly and symmetrically on each participant's head to cover the scalp.

MIO

A 12-week, manualized, individual parenting psychotherapy developed specifically for mothers with addictions administered by the Principal Investigator. It is designed to foster a mother's capacity for mentalization or reflective functioning (RF). MIO is offered in conjunction with standard addiction treatment.

Primary outcome measure

  • Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli [ Time Frame: Week 1 and Week 14 ]
  • Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI) [ Time Frame: Week 1 and Week 14 ]
  • Change in mothers' reflective functioning assessed using the self-report Parental Reflective Functioning Questionnaire (PRFQ) [ Time Frame: Week 1 and Week 14 ]
  • Change in mothers' certainty about mental states assessed using the self-report Certainty about Mental States Questionnaire (CAMSQ) [ Time Frame: Week 1 and Week 14 ]
  • Change in mothers' mind-mindedness assessed using the Five-Minute Speech Sample (MM) [ Time Frame: Week 1 and Week 14 ]

Central Contacts and Locations

Central contacts

Locations

Yale Child Studies Center

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-10-29.