Feasibility, Acceptability, and Fidelity of Motivational Interviewing to Increase Maternal NICU Presence

NCT06488196 | Completed

• 1 other identifier: IRB00182045
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Intensive Care

Keywords

motivational interviewing; NICU

Outcome Measures

Primary Outcomes (1)

• Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session

  Feasibility as assessed by \>75% of MI-randomized mothers receiving \> one MI session

  3 years

Secondary Outcomes (1)

• Acceptability as assessed by the number of mothers' open to completing additional MI session/s

  3 years

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing

Treatment as Usual

ACTIVE COMPARATOR

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.

Other: Treatment As Usual

Interventions

Motivational Interviewing BEHAVIORAL

Motivational interviewing (MI) is a person-centered, goal-oriented psychotherapeutic intervention designed to enhance the recipient's motivation for and commitment to a target behavior or behavior change. MI's core action mechanisms include strengthening the recipient's change talk (e.g., assertions about desire and commitment toward the target behavior) and softening the recipient's sustain talk (e.g., statements about barriers). MI clinicians achieve these goals using specific micro-skills (e.g., reflective listening) that reflect MI's fundamental spirits (i.e. collaboration, acceptance, compassion, evocation.

Motivational Interviewing

Treatment As Usual OTHER

TAU included the opportunity for mothers to meet with a NICU psychologist or psychology trainee at least once-per-week for supportive care.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mothers of infants hospitalized in the NICU
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English- or Spanish-speaking mothers \>18 years-old with a NICU-hospitalized infant

You may not qualify if:

• Suicidality, cognitive disability preclude consent/participation, or psychotic/manic symptoms

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Interventions

Motivational Interviewing; Therapeutics

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Melissa Faith, PhD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators used a randomized controlled trial (RCT) design and randomized consenting mothers (1:1) in blocks of 10 to the MI-arm or a treatment-as-usual (TAU) control-arm.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: November 2, 2018
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)