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Critical IllnessPhase 2NCT06208332

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

A Phase 2 study testing "What Is Important to Us" Communication Intervention in people with Critical Illness and Neurologic Disorder, run by Seattle Children's Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Critical Illness, Neurologic Disorder
What is being tested?
"What Is Important to Us" Communication Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
10 Feb 2025to 15 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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
  • -Previous study participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jori Bogetz, MD contact

206-884-0572

jori.bogetz@seattlechildrens.org

United States1 site, 1 recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Jori Bogetz, MD, jori.bogetz@seattlechildrens.org

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
"What Is Important to Us" Communication Intervention
Keywords
pediatric palliative care, communication, severe neurological impairment
Medical subject headings
Critical Illness, Nervous System Diseases, Communication, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "What Is Important to Us" Communication InterventionBehavioural

    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..

Study groups in NCT06208332
Study groupRoleWhat they receive
"What Is Important to US" Communication InterventionExperimentalThe "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.
Receives: Behavioral: "What Is Important to Us" Communication Intervention
Usual CareNo interventionUsual supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    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.

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

  2. Acceptability

    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.

    Measured: PICU discharge (assessed up to 4 weeks)

Secondary outcomes (7)

  1. Perceived Stress Scale (PSS)

    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.

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

  2. Neuro-QOL Stigma Short-Form

    8-item measure of stigma associated with neurological illness; 5-point Likert scale; higher scores suggest more perceived stigma.

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

  3. Benefit Finding Scale

    14-item measure of areas of personal growth; 5-point Likert scale (range 10-49); higher scores suggest more benefit finding.

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

  4. Connor Davidson Resilience Scale (CD-RISC 10)

    10-item measure of self-perceived resilience; 5-point Likert scale (range 0-40); higher scores suggesting greater resilience.

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

  5. Human Connection Scale (HCS)

    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.

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

  6. Climate of Respect Evaluation in Intensive Care Units (CORE-ICU)

    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).

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

  7. Interpersonal Reactivity Index (IRI) Empathetic Concern and Perspective-taking Subsections

    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.

    Measured: enrollment and PICU discharge (assessed up to 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start10 Feb 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208332
Sponsor's protocol ID
STUDY00004439
Status last verified
May 2025
First submitted
5 Jan 2024
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Allen J, Brenner M, Hauer J, Molloy E, McDonald D. Severe Neurological Impairment: A delphi consensus-based definition. Eur J Paediatr Neurol. 2020 Nov;29:81-86. doi: 10.1016/j.ejpn.2020.09.001. Epub 2020 Sep 11.

    PubMed 32951992

  • Feudtner C, Kang TI, Hexem KR, Friedrichsdorf SJ, Osenga K, Siden H, Friebert SE, Hays RM, Dussel V, Wolfe J. Pediatric palliative care patients: a prospective multicenter cohort study. Pediatrics. 2011 Jun;127(6):1094-101. doi: 10.1542/peds.2010-3225. Epub 2011 May 9.

    PubMed 21555495

  • Berry JG, Poduri A, Bonkowsky JL, Zhou J, Graham DA, Welch C, Putney H, Srivastava R. Trends in resource utilization by children with neurological impairment in the United States inpatient health care system: a repeat cross-sectional study. PLoS Med. 2012 Jan;9(1):e1001158. doi: 10.1371/journal.pmed.1001158. Epub 2012 Jan 17.

    PubMed 22272190

  • Moreau JF, Fink EL, Hartman ME, Angus DC, Bell MJ, Linde-Zwirble WT, Watson RS. Hospitalizations of children with neurologic disorders in the United States. Pediatr Crit Care Med. 2013 Oct;14(8):801-10. doi: 10.1097/PCC.0b013e31828aa71f.

    PubMed 23842588

  • DeCourcey DD, Silverman M, Oladunjoye A, Balkin EM, Wolfe J. Patterns of Care at the End of Life for Children and Young Adults with Life-Threatening Complex Chronic Conditions. J Pediatr. 2018 Feb;193:196-203.e2. doi: 10.1016/j.jpeds.2017.09.078. Epub 2017 Nov 22.

    PubMed 29174080

  • Nolan R, Luther B, Young P, Murphy NA. Differing perceptions regarding quality of life and inpatient treatment goals for children with severe disabilities. Acad Pediatr. 2014 Nov-Dec;14(6):574-80. doi: 10.1016/j.acap.2014.02.012. Epub 2014 May 6.

    PubMed 24816425

  • Bogetz JF, Trowbridge A, Lewis H, Jonas D, Hauer J, Rosenberg AR. Forming Clinician-Parent Therapeutic Alliance for Children With Severe Neurologic Impairment. Hosp Pediatr. 2022 Mar 1;12(3):282-292. doi: 10.1542/hpeds.2021-006316.

    PubMed 35141756

  • Bogetz J, Ayala E, Anderson J, Morris L, Barton KS, Bradford MC, Zhou C, Yi-Frazier J, Watson RS, Rosenberg AR. A photo-narrative intervention protocol for clinicians and parents of children with severe neurological impairment in the PICU. Contemp Clin Trials Commun. 2025 Feb 11;44:101455. doi: 10.1016/j.conctc.2025.101455. eCollection 2025 Apr.

    PubMed 40034723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing "What Is Important to Us" Communication Intervention in people with Critical Illness and Neurologic Disorder, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jori Bogetz, MD (206-884-0572, jori.bogetz@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: enrollment and PICU discharge (assessed up to 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06208332, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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