Neuroplasticity in Maternal Opioid Use Disorder (OUD)

Обзор

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.

Подробное описание

This is a study conducted at the Child Study Center (CSC) in the Yale School of Medicine. It involves mothers in treatment for OUD who are caring for infants who are 4-12 months old.

15 mothers will complete 1 study visit, which will last 2.5 hours. It will start with informed consent and then will include demographics, EEG/ERP, a multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).

Participants will then complete 12 treatment (Mothering from the Inside Out (MIO)) visits, and 1 post-treatment data collection visit.

Visits 2-13 (1 hour each) consist of participation in Mothering from the Inside Out (MIO).

Visit 14 (2.5 hours) includes participation in the ERP paradigm and the multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

• Mothers' baseline substance use assessed using the Addiction Severity Index (ASI-Lite) [Срок оценки: Week 1]
• Change in mothers' depression assessed using the Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: Week 1 and Week 14]
• Change in mothers' depression assessed using the Patient Health Questionnaire-2 (PHQ-2) [Срок оценки: Week 1 and Week 14]
• Change in mothers' anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Week 1 and Week 14]
• Change in mothers' stress assessed using the Parenting Stress Index- Short Form (PSI-SF) [Срок оценки: Week 1 and Week 14]
• Mothers' experience of childhood maltreatment assessed using the Childhood Trauma Questionnaire (CTQ) [Срок оценки: Week 1]
• Mothers' experience of childhood adversity assessed using the Adverse Childhood Experiences Scale (ACES) [Срок оценки: Week 1]
• Change in mothers' internalized stigma assessed using the Brief Opioid Stigma Scale (BOSS) [Срок оценки: Week 1 and Week 14]
• Change in mothers' internalized stigma assessed using the Substance Use Stigma Mechanism Scale (SU-SMS) [Срок оценки: Week 1 and Week 14]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Yale Child Studies Center — New Haven

Идентификаторы

NCT: NCT05495984 · 2000033065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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