The "What Is Important to Us" Communication Intervention Pilot Clinical Trial

February 12, 2026 updated by: Jori Bogetz, Seattle Children's Hospital
The objective of this study is to conduct a pilot randomized controlled trial (RCT) of a photo-narrative communication intervention developed by our study team with patients/parents of children with severe neurological impairment (SNI) and their pediatric intensive care unit (PICU) clinicians to assess feasibility, acceptability, and early efficacy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pilot randomized controlled trial of the "What Is Important to Us" communication intervention. Parents of children with severe neurological impairment in the ICU and their clinicians will be enrolled at the time of the child's ICU admission (baseline) and complete pre-intervention surveys before randomization. Intervention-arm parents and clinicians will complete the "What Is Important to Us" intervention. Post-intervention (within 1 week of ICU discharge) surveys will be completed by parents and clinicians. The control-arm parents will receive usual care (including standard psychosocial supports such as social work). Control-arm parents and clinicians will complete study surveys at the same timepoints. Semi-structured interviews will be completed with intervention-arm parents and clinicians following survey completion to guide further intervention enhancements and future work.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Children with SNI

Inclusion

  • Hospitalized at study sites
  • Ages 6 months through 25 years old
  • Has had SNI for >6 months, defined as permanent static or progressive central nervous system injury resulting in motor/cognitive impairment and medical complexity

Exclusion

  • Has never previously been home/discharged
  • Has an expected hospital length of stay <2 days
  • Has a life expectancy of <4 weeks
  • Previous study participation

Parents

Inclusion

  • Parent/legally authorized representative of an eligible child with SNI
  • Preferred language of care English and/or Spanish

Clinicians

Inclusion -Licensed physicians, nurses, advanced practice providers, respiratory therapists at study site

Exclusion

-Previous study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "What Is Important to US" Communication Intervention
The "What Is Important to Us" intervention is a photo-narrative invention that prompts parents to select a total of 1-3 photos that are then displayed at their child's ICU bedside representing: 1) who is important in our family; 2) what strengthens us as parents; 3) how we know our child is feeling well; and 4) what makes our child's hospitalization easier. Parents are encouraged to discuss the pictures with clinicians caring for their child. Clinicians caring for the child are sent the photos electronically along with suggested discussion prompts to use with parents.
Behavioral: "What Is Important to Us" Communication Intervention
The "What Is Important to Us" intervention is a photo-narrative invention that prompts parents to select a total of 1-3 photos that are then displayed at their child's ICU bedside representing: 1) who is important in our family; 2) what strengthens us as parents; 3) how we know our child is feeling well; and 4) what makes our child's hospitalization easier. Parents are encouraged to discuss the pictures with clinicians caring for their child. Clinicians caring for the child are sent the photos electronically along with suggested discussion prompts to use with parents..
No Intervention: Usual Care
Usual supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
Feasibility will be set at a benchmark of 70% and assessed by calculating: 1) the percent enrolled (total enrolled/total approached), plus a 95% confidence interval; and 2) the percent completion (parents completing intervention/total in intervention arm), plus a 95% confidence interval.
enrollment and PICU discharge (assessed up to 4 weeks)
Acceptability
Time Frame: PICU discharge (assessed up to 4 weeks)
Acceptability will be set at a benchmark of 70% and assessed by computing the intervention recommendation percent (total number of intervention parents likely to very likely to recommend the intervention to other parents/total number of parents in the intervention arm), plus a 95% confidence interval.
PICU discharge (assessed up to 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS)
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
10-item measure of the degree to which participants appraise their situation as stressful; 5-point Likert scale (range 0- 40); scores 14-26 moderate and >27 high levels of stress.
enrollment and PICU discharge (assessed up to 4 weeks)
Neuro-QOL Stigma Short-Form
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
8-item measure of stigma associated with neurological illness; 5-point Likert scale; higher scores suggest more perceived stigma.
enrollment and PICU discharge (assessed up to 4 weeks)
Benefit Finding Scale
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
14-item measure of areas of personal growth; 5-point Likert scale (range 10-49); higher scores suggest more benefit finding.
enrollment and PICU discharge (assessed up to 4 weeks)
Connor Davidson Resilience Scale (CD-RISC 10)
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
10-item measure of self-perceived resilience; 5-point Likert scale (range 0-40); higher scores suggesting greater resilience.
enrollment and PICU discharge (assessed up to 4 weeks)
Human Connection Scale (HCS)
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
16-item measure of sense of fondness, mutual understanding, caring, and trust with clinicians; 4-point Likert scale (range 16-64); higher scores suggest greater therapeutic alliance.
enrollment and PICU discharge (assessed up to 4 weeks)
Climate of Respect Evaluation in Intensive Care Units (CORE-ICU)
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
21-item measure of 3 domains of respect as perceived by patients/surrogates in the ICU; 5-point Likert scale; higher scores on overall (range 7-42) and respectful behaviors (range 10-60) suggest greater respect, and lower respect on the disrespectful behaviors subsection (range 4-24).
enrollment and PICU discharge (assessed up to 4 weeks)
Interpersonal Reactivity Index (IRI) Empathetic Concern and Perspective-taking Subsections
Time Frame: enrollment and PICU discharge (assessed up to 4 weeks)
The 7-item empathic concern scale measures feelings of sympathy towards other people and is strongly correlated with measures of concern for others. The 7-item perspective-taking scale measures the tendency to adopt the psychological point of view of other people. Items are rated on a 4-point Likert scale and have very good internal consistency (Cronbach alpha=.81-.87) and validity in clinicians.
enrollment and PICU discharge (assessed up to 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Investigators

  • Principal Investigator: Jori Bogetz, MD, Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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