Neuroplasticity in Maternal Opioid Use Disorder (OUD)
This study is for mothers with Opioid Use Disorder (OUD) who are currently in treatment and taking medication for OUD. It aims to understand how a mother's brain changes and adapts, especially during the time after childbirth. Researchers will study how a specific type of therapy called Mothering from the Inside Out (MIO) affects these brain changes and a mother's ability to understand her own and her baby's feelings (mentalization). They will measure brain activity using EEG (electroencephalography) while mothers look at infant pictures and listen to infant cries. The study hopes to see improvements in brain responses and mentalization after mothers complete the MIO therapy. This study is looking for 15 mothers to participate.
- Study design
- This is an interventional study involving 15 mothers. It is a single-arm study, meaning all participants receive the same intervention.
- What's involved
- You would have one initial 2.5-hour visit, followed by 12 weekly 1-hour therapy sessions (MIO), and then a final 2.5-hour visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your brain activity and mentalization will be measured at the beginning of the study (Week 1) and again after the 12 weeks of therapy (Week 14).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neuroplasticity in Maternal Opioid Use Disorder (OUD)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Amanda Lowell, Ph.D. · PRINCIPAL_INVESTIGATOR · Yale University
- Helena Rutherford, PhD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuliWeek 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 maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)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' reflective functioning assessed using the self-report Parental Reflective Functioning Questionnaire (PRFQ)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)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.
- Change in mothers' mind-mindedness assessed using the Five-Minute Speech Sample (MM)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.