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ClinicalTrials.gov ID

NCT07390773

Lead Sponsor

Duke UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

495Estimated

Last Update Posted

May 22, 2026Actual

Start Date

Jul 2026Estimated

Primary Completion Date

Aug 2028Estimated

Completion Date

Oct 2028Estimated

Official Title

Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children

Brief Summary

Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support parents as they make decisions for their child and communicate with the health care team. The main questions this study aims to answer are:

1. Do parents who receive the BRIDGE intervention report being better prepared to make decisions for their child?
2. Do parents who receive the BRIDGE intervention report less regret about the decisions they made for their child?

Participants will complete surveys at baseline and approximately 2 weeks, 6 months, and 12 months following enrollment. Some participants will also participate in interviews about their experiences.

• Decision Making
• Neonatal Critical Illness
• Pediatric Critical Illness

• BRIDGE intervention

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

Child inclusion criteria will include:

• Age < 5 years
• Admission to a critical care unit within the preceding 14 days
• An anticipated serious health care decision, defined as a decision about initiating, not initiating, or withdrawing life-sustaining treatment and/or a decision about major intervention.

Parent inclusion criteria will include:

• Age ≥ 18 years
• The ability speak English or Spanish.

Clinician inclusion criteria will include

• Clinical team member of an enrolled child and parent in the intervention group
• Completion of residency or equivalent training.

Exclusion Criteria:

• Children, parents or clinicians who do not meet the inclusion criteria above.

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Duke UniversityOTHER

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

amanda.fristoe@duke.edu919-684-4833