The "What Is Important to Us" Communication Intervention Pilot Clinical Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorSeattle Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Has never previously been home/discharged
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
"What Is Important to Us" Communication Intervention
BehavioralThe "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..
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: "What Is Important to US" Communication InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
PICU discharge (assessed up to 4 weeks)Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
enrollment and PICU discharge (assessed up to 4 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov