Neuroplasticity in Maternal Opioid Use Disorder (OUD)
A legfontosabb adatok
- Ki végzi
- Yale University
- Hol
- New Haven (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Felfüggesztve
- Résztvevők
- 15 fő, tervezett
- Kezdés
- 2023. jan. 1.
- Várható befejezés
- 2026. dec.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- ERPs with electroencephalography (EEG)
- MIO
- A regiszteradat frissítve
- 2026. szeptember 14.
- Miért állt le
- PI in transition, assessing feasibility of study continuation
Ki vehet részt
- Életkor
- 21 év – 45 év
- Nem
- Csak nők
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- 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)
Helyszínek itt: Egyesült Államok
- Yale Child Studies CenterNew Haven, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Primary Objective: Event-Related Potentials (ERPs)A vizsgált kezelés
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
Kezelés: ERPs with electroencephalography (EEG)
- Secondary Objective: ERPs + Mothering from the Inside Out (MIO)A vizsgált kezelés
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).
Kezelés: ERPs with electroencephalography (EEG) és MIO
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. szeptember 14.