A Phase 2 interventional study of "What Is Important to Us" Communication Intervention in Critical Illness and Neurologic Disorder, sponsored by Seattle Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Seattle Children's Hospital · Phase 2, Interventional, and Supportive care
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 160 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.
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Children with SNI
Inclusion
Exclusion
Parents
Inclusion
Clinicians
Inclusion -Licensed physicians, nurses, advanced practice providers, respiratory therapists at study site
Exclusion
-Previous study participation
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
Usual supportive care
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..
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.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
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.
Time frame: PICU discharge (assessed up to 4 weeks)
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.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Neuro-QOL Stigma Short-Form
8-item measure of stigma associated with neurological illness; 5-point Likert scale; higher scores suggest more perceived stigma.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Benefit Finding Scale
14-item measure of areas of personal growth; 5-point Likert scale (range 10-49); higher scores suggest more benefit finding.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
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.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
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.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
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).
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
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.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
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