Neuroplasticity in Maternal Opioid Use Disorder (OUD)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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).
干预措施: ERPs with electroencephalography (EEG) (Behavioral)
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).
干预措施: MIO (Behavioral)
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
干预措施: ERPs with electroencephalography (EEG) (Behavioral)
结局指标
主要结局
Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)
时间窗: Week 1 and Week 14
The PDI is a semi-structured interview with 19 questions eliciting a parent's verbal narrative about common emotionally-challenging aspects of parenting. The interview is recorded, transcribed, and each of the 19 responses is rated on a 10-point scale where: a score of 1 indicates complete absence of recognition of mental states (events are described solely in terms of behavior) and scores above 5 indicate increasingly elaborate and sophisticated understanding of how mental states function and influence behavior. Reliable coders assign an Overall Score to the protocol that represents the parent's modal level of response. The PDI requires approximately 60 minutes to complete.
Change in mothers' mind-mindedness assessed using the Five-Minute Speech Sample (MM)
时间窗: Week 1 and Week 14
On the five-minute speech sample, mothers will be asked to describe their child for five minutes; responses will be recorded, transcribed, and coded using the representational MM coding manual. Descriptions that refer to mental states (e.g., cognitions, emotions, desires, interests) are identified as mind-minded. The frequency of mind-minded comments will be calculated, as will the proportion of mind-minded to non- mind-minded comments, to control for verbosity.
Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli
时间窗: Week 1 and Week 14
E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes. Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. Net Station 4.5 will be used to pre-process EEG data (first be digitally filtered, then segmented into 1-second epochs (100ms pre- and 900ms post-stimulus onset). Net Station artifact detection will be set to detect artifact. Spline interpolation will be used to replace channels with artifacts in more than 40% of trials. Ocular Artifact Removal (OAR), using a blink slope threshold of 14µV/ms, will be applied to data for all participants. EEG data will next be re-referenced to the average reference of all electrodes and baseline corrected to the 100ms interval pre-stimulus onset. Lastly, the EEG data will be averaged across stimulus conditions for each participant. The N170, N100, and P300 will be visually inspected in the grand-averaged data and verified for each participant.
Change in mothers' reflective functioning assessed using the self-report Parental Reflective Functioning Questionnaire (PRFQ)
时间窗: Week 1 and Week 14
The PRFQ is an 18-item self-report questionnaire to quantify levels of 3 key components of parental RF: Interest \& Curiosity surrounding their child's mental states, Certainty in the recognition of their child's mental states, and Pre-Mentalizing or difficulty in considering the child's mental states. Optimal RF is indicated by higher scores on the interest and curiosity subscale, moderate scores on the certainty subscale, and lower scores on the pre-mentalizing subscale. Participants rate their responses on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The PRFQ requires approximately 10 minutes to complete.
Change in mothers' certainty about mental states assessed using the self-report Certainty about Mental States Questionnaire (CAMSQ)
时间窗: Week 1 and Week 14
The CAMSQ is a psychometrically sound 20-item self-report questionnaire. The CAMSQ assesses two maladaptive variants of subjective certainty about mental states that can be linked to hypomentalizing and hypermentalizing. The CAMSQ yields two subscales representing certainty about one's own metal states, and certainty about others' mental states. Items are scored by taking the mean of item responses (never = 1, almost never = 2, sometimes = 3, half of the time = 4, often = 5, almost always = 6, always = 7). The CAMSQ requires approximately 15 minutes to complete.
次要结局
- Mothers' baseline substance use assessed using the Addiction Severity Index (ASI-Lite)(Week 1)
- Change in mothers' depression assessed using the Patient Health Questionnaire-2 (PHQ-2)(Week 1 and Week 14)
- Change in mothers' stress assessed using the Parenting Stress Index- Short Form (PSI-SF)(Week 1 and Week 14)
- Change in mothers' anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7)(Week 1 and Week 14)
- Change in mothers' internalized stigma assessed using the Substance Use Stigma Mechanism Scale (SU-SMS)(Week 1 and Week 14)
- Change in mothers' depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)(Week 1 and Week 14)
- Mothers' experience of childhood maltreatment assessed using the Childhood Trauma Questionnaire (CTQ)(Week 1)
- Mothers' experience of childhood adversity assessed using the Adverse Childhood Experiences Scale (ACES)(Week 1)
- Change in mothers' internalized stigma assessed using the Brief Opioid Stigma Scale (BOSS)(Week 1 and Week 14)