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Motivational Interviewing for Neonatal Intensive Care Unit (NICU)

N/A
Waitlist Available
Led By Melissa Faith, PhD
Research Sponsored by Johns Hopkins All Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* English- or Spanish-speaking mothers \>18 years-old with a NICU-hospitalized infant
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. To date, no behavioral interventions have been conducted to promote increased maternal visitation patterns in NICU settings. This project will aim to fill this gap in the literature by conducting a pilot study that uses a motivational interviewing intervention with the aim of increasing maternal visitation rates to a level IV NICU.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session
Secondary study objectives
Acceptability as assessed by the number of mothers' open to completing additional MI session/s

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Motivational InterviewingExperimental Treatment1 Intervention
Mothers in the MI-arm received up to six weekly MI sessions until the baby was discharged from the NICU. Mothers whose baby was discharged prior to or during week six completed measures at enrollment and NICU discharge. Mothers whose baby was discharged after week six completed questionnaires at enrollment and at the end of week six. Mothers could choose whether to complete MI in English or Spanish. Native Spanish-speaking, ethnically-matched providers conducted Spanish-language sessions. Study team members offered to read questionnaires aloud and record responses; however, all participants chose to independently complete paper-and-pencil measures.
Group II: Treatment as UsualActive Control1 Intervention
In the institution in which the investigators conducted this study, per institutional standards, TAU included the opportunity for mothers to meet with a NICU psychologist or psychology trainee at least once-per-week for supportive care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational Interviewing
2020
Completed Phase 3
~8850

Find a Location

Who is running the clinical trial?

Johns Hopkins All Children's HospitalLead Sponsor
44 Previous Clinical Trials
5,007,539 Total Patients Enrolled
Melissa Faith, PhDPrincipal InvestigatorJohns Hopkins All Children's Hospital
~14 spots leftby Sep 2025
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