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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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