What this study is
Simplified from ClinicalTrials.govTesting a digital cognitive behavioral therapy program that teaches coping strategies, to learn whether children and parents will use and accept it and how it affects anxiety, in children ages 7 to 13 who survived a pediatric intensive care unit stay, and their parents.
Read the original summary from ClinicalTrials.gov
Survivors of Pediatric Intensive Care Unit (PICU) admissions often experience adverse mental health consequences, either as a result of, or associated with, their intensive care stay. Evidence-based digital cognitive behavioral therapy (dCBT) tools exist for both children and parents to learn cognitive behavioral strategies. In this feasibility study, we aim to measure the adoption and acceptability of a dCBT tool among PICU survivors and their parents. We hypothesize that >50% of subjects will meet completion criteria for these programs, and that we will observe a trend toward improved anxiety scores.
What's being tested
- Digital Cognitive Behavioral Therapy
Intervention · OTHER
Subjects in the intervention arm will receive access to a commercially available, digital cognitive behavioral therapy (dCBT) tool. This dCBT tool is specifically designed for children and their caregivers, and has been validated in other care settings.
Study details
- Official title
- BRAVE-PICU: Building Resilience Through Anxiety Virtual Education in PICU Survivors
- Sponsor
- University of Rochester
- Conditions
- Critical Illness Recovery · Mental Health
- Enrolling
- 70 people
- Starts
- 2027-01-01
- Est. completion
- 2027-09-01
- Design
- Open-label, randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years – 13 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥ 7 and ≤ 13 (the dCBT program is only validated for patients within this age range)
- Admitted to the GCH PICU and have an anticipated discharge date in the subsequent 1 - 3 days
- Be able to interact with an iPad or computer device, as assessed by caregivers
- English speaking subjects due to the lack of translated versions of the dCBT tool
You can't join if
- No specific exclusion criteria
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openGolisano Children's Hospital
Rochester, New York, United States
- Adam Dziorny, MD, PhD · Contact585-276-3014adam_dziorny@urmc.rochester.edu
Study team
Sponsor
University of Rochester
Study ID STUDY000012072
Principal investigator
Adam Dziorny, MD, PhD
University of Rochester
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.