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Parenting Intervention for Opioid Use Disorder

N/A

Recruiting

Led By Helena Rutherford, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 and week 14

Awards & highlights

Study Summary

This trial will test anevidence-based parenting intervention for mothers with opioid use disorder, to see if it optimizes outcomes by taking advantage of the neuroplasticity in the perinatal period.

Who is the study for?

This trial is for mothers aged 21-45 with infants aged 4-12 months, who are receiving treatment for opioid use disorder and on medication-assisted therapy. It's not suitable for those with severe addiction needing detox, non-English speakers, individuals unable to complete the study due to legal issues or cannot give informed consent, or if the child spends less than half the time in their mother's custody.Check my eligibility

What is being tested?

The study tests how an evidence-based parenting intervention affects brain changes in mothers with OUD using EEG technology. Participants will have one lab visit before treatment, attend 12 sessions of the intervention, and then another lab visit after completing these sessions.See study design

What are the potential side effects?

Since this trial involves a behavioral intervention and EEG monitoring rather than medication or invasive procedures, it may not have typical side effects; however discomfort from wearing EEG equipment or emotional distress during therapy could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 and week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 and week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 and week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)

Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli

Change in mothers' certainty about mental states assessed using the self-report Certainty about Mental States Questionnaire (CAMSQ)

+2 more

Secondary outcome measures

Change in mothers' anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7)

Change in mothers' depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)

Change in mothers' depression assessed using the Patient Health Questionnaire-2 (PHQ-2)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Secondary Objective: ERPs + Mothering from the Inside Out (MIO)Experimental Treatment2 Interventions

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).

Group II: Primary Objective: Event-Related Potentials (ERPs)Experimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,426 Total Patients Enrolled

Alkermes, Inc.Industry Sponsor

114 Previous Clinical Trials

26,873 Total Patients Enrolled

Helena Rutherford, PhDPrincipal InvestigatorYale University

2 Previous Clinical Trials

85 Total Patients Enrolled

Media Library

ERPs with electroencephalography (EEG) Clinical Trial Eligibility Overview. Trial Name: NCT05495984 — N/A

Opioid Use Disorder Research Study Groups: Primary Objective: Event-Related Potentials (ERPs), Secondary Objective: ERPs + Mothering from the Inside Out (MIO)

Opioid Use Disorder Clinical Trial 2023: ERPs with electroencephalography (EEG) Highlights & Side Effects. Trial Name: NCT05495984 — N/A

ERPs with electroencephalography (EEG) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05495984 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participation in this research effort?

"This trial is recruiting 30 individuals, aged between 21 and 45, who are diagnosed with opioid use disorder (OUD) and have offspring within the 4-month to 12-month age range. Furthermore, participants must be enrolled in substance abuse treatment programmes and taking MOUD medications."

Answered by AI

What are the primary goals that this medical trial is trying to accomplish?

"The primary endpoints of this clinical trial, evaluated during Week 1 and 15, focus on the alteration in mothers' Event-related potentials (ERPs) when exposed to unknown infant face & cry stimuli. Secondary outcomes include Mothers' experience of childhood maltreatment assessed using the Childhood Trauma Questionnaire (CTQ), Change in depression as gauged by Edinburgh Postnatal Depression Scale (EPDS), and Change in stress through Parenting Stress Index - Short Form(PSI-SF). Each assessment requires approximately 5 to 15 minutes respectively."

Answered by AI

Is this research open to individuals younger than seventy years old?

"According to the trial's eligibility requirements, individuals between 21 and 45 years old are considered qualified applicants. By contrast, there are 89 clinical trials available for those under 18 while 400 are accessible to patients aged 65 or above."

Answered by AI

Is enrollment still available for this experiment?

"The clinicaltrials.gov database indicates that, as of November 9th 2022, this medical trial is no longer recruiting patients. Despite this fact, there are 535 other trials actively seeking participants at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuroplasticity in Maternal Opioid Use Disorder (OUD)

2023. "Neuroplasticity in Maternal Opioid Use Disorder (OUD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05495984.