Critical Illness RecoveryBRAVE-PICUNCT07906366
Building Resilience Through Anxiety Virtual Education in PICU Survivors
A study testing Digital Cognitive Behavioral Therapy in people with Critical Illness Recovery and Mental Health, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Critical Illness Recovery, Mental Health
- What is being tested?
- Digital Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Sep 2027
- Phase
- Interventional
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Golisano Children's Hospital
Rochester, New York, 14642
Adam Dziorny, MD, PhD, 585-276-3014, adam_dziorny@urmc.rochester.edu
About this study
Official title: BRAVE-PICU: Building Resilience Through Anxiety Virtual Education in PICU Survivors
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.
Read the detailed description
Childhood critical illness is common and impacts nearly 1 in 6 hospitalized children. Although overall pediatric intensive care unit (PICU) mortality is decreasing, survivors are experiencing longer stays, greater symptom severity, and greater morbidity. Outcomes reflected in the post-intensive care syndrome in pediatrics (PICS-p) framework are expressed across several domains, including cognitive, physical, and emotional health. Survivor emotional health is often negatively impacted in both the short and long term, with rates of acute posttraumatic stress and posttraumatic stress disorder among survivors reaching more than 88%. Critically, small studies suggest these trajectories are malleable with 40-70% of survivors demonstrating post-traumatic growth if they are supported. If left untreated, mental health (MH) symptoms increase risk for PICU readmission and adverse physical health outcomes. Despite increasing evidence that MH follow-up post-ICU discharge results in improved survivor outcomes, we and others have shown MH follow-up rates are <12%, much lower than rates of new MH pathology. Critically, referral remains the primary intervention available to PICU survivors and availability of MH care remains a significant barrier to accessing adequate care. There is an urgent need to identify alternative pathways to mental health care.
Digital cognitive behavioral therapy (dCBT) tools show promise in filling the gaps between service availability and need. Such tools do not replace the need for skilled providers; however, they show considerable promise in improving access to mental health tools that promote resilience, such as emotion identification, coping skills, and an approach mindset. Despite successful implementation of these tools in schools, community clinics, and outpatient medical settings, they have never before been used in critical care settings.
- Conditions
- Critical Illness Recovery, Mental Health
- Being tested
- Digital Cognitive Behavioral Therapy
- Keywords
- Digital Cognitive Behavioral Therapy, Post-Intensive Care Syndrome
- Medical subject headings
- Psychological Well-Being, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioral TherapyOther
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects in this arm will be randomized to an online, commercially available, digital cognitive behavioral therapy tool for use following discharge from the hospital. Receives: Other: Digital Cognitive Behavioral Therapy |
| Control | No intervention | Subjects in this arm will not receive access to the digital cognitive behavioral therapy tool. They will experience usual post-hospital care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen for Child Anxiety and Related Disorders (SCARED)
Subjects in both arms will receive Screen for Child Anxiety and Related Disorders (SCARED) instrument upon enrollment (baseline) and at study completion (12 weeks). This instrument is scored from 0 to 82 (2 points per question) and provides a measure of anxiety, avoidance, and panic disorders. Higher scores indicate greater anxiety and related disorders. It was developed by Boris Birmaher, MD, Suneeta Khetarpal, MD, Marlane Cully, MEd, David Brent, MD, and Sandra McKenzie, PhD, Western Psychiatric Institute and Clinic, University of Pittsburgh.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
System Usage
Usage data of the dCBT product will be provided for subjects in the intervention arm. We will receive information about the number of logins and the active time spent in the system.
Measured: 12 Weeks
System Usability Scales
Subjects in the intervention arm will receive the System Usability Scales instrument at study completion. This scale measures the usability of the Camp Cope-a-lot system and was adapted from the SUS developed by John Brooke in 1986. It is scored from 0 to 100, with higher scores meaning greater usability.
Measured: 12 Weeks
Child and Adolescent Trauma Screen (CATS)
Subjects in both arms will receive the Child and Adolescent Trauma Screen (CATS) at baseline. This instrument asks about stressful or scary events that happened to the subject. It is scored from 0 to 15, with higher scores indicating more trauma history. It was developed by Prof. Lutz Goldbeck (Ph.D.) \& Prof. Lucy Berliner (Ph.D.).
Measured: Baseline
Barriers to Treatment Participation Scale (BTPS)
Subjects in both arms will receive the Barriers to Treatment Participation Scale (BTPS) at Baseline. It asks questions about specific barriers to seeking psychological help, counseling, or advice for the subject. It is scored from 1 to 38 with higher scores indicating greater barriers to treatment participation.
Measured: Baseline
Digital Competence Scale
Subjects in both arms will receive the Digital Competence Scale at Baseline. It is a short self-assessment instrument for measuring digital competencies. It is scored from 0 to 12 with higher scores indicating greater digital competence. It was developed by Schwarz (2024).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness RecoveryStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam C Dziorny, University of Rochester
- Investigators
- Adam Dziorny, MD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906366
- Sponsor's protocol ID
- STUDY000012072
- Acronym
- BRAVE-PICU
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVE-PICU: Building Resilience Through Anxiety Virtual Education in PICU Survivors
- ClinicalTrials.gov ID
- NCT07906366
- Acronym / sponsor ID
- BRAVE-PICU / STUDY000012072
- Conditions
- Critical Illness Recovery, Mental Health
- Keywords
- Digital Cognitive Behavioral Therapy, Post-Intensive Care Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood critical illness is common and impacts nearly 1 in 6 hospitalized children. Although overall pediatric intensive care unit (PICU) mortality is decreasing, survivors are experiencing longer stays, greater symptom severity, and greater morbidity. Outcomes reflected in the post-intensive care syndrome in pediatrics (PICS-p) framework are expressed across several domains, including cognitive, physical, and emotional health. Survivor emotional health is often negatively impacted in both the short and long term, with rates of acute posttraumatic stress and posttraumatic stress disorder among survivors reaching more than 88%. Critically, small studies suggest these trajectories are malleable with 40-70% of survivors demonstrating post-traumatic growth if they are supported. If left untreated, mental health (MH) symptoms increase risk for PICU readmission and adverse physical health outcomes. Despite increasing evidence that MH follow-up post-ICU discharge results in improved survivor outcomes, we and others have shown MH follow-up rates are <12%, much lower than rates of new MH pathology. Critically, referral remains the primary intervention available to PICU survivors and availability of MH care remains a significant barrier to accessing adequate care. There is an urgent need to identify alternative pathways to mental health care.
Digital cognitive behavioral therapy (dCBT) tools show promise in filling the gaps between service availability and need. Such tools do not replace the need for skilled providers; however, they show considerable promise in improving access to mental health tools that promote resilience, such as emotion identification, coping skills, and an approach mindset. Despite successful implementation of these tools in schools, community clinics, and outpatient medical settings, they have never before been used in critical care settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Digital Cognitive Behavioral TherapySubjects in this arm will be randomized to an online, commercially available, digital cognitive behavioral therapy tool for use following discharge from the hospital. |
| Control | No intervention | –Subjects in this arm will not receive access to the digital cognitive behavioral therapy tool. They will experience usual post-hospital care. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cognitive Behavioral TherapySubjects 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. | Other | Intervention |
Primary outcome
Screen for Child Anxiety and Related Disorders (SCARED)
Time frame: Baseline and 12 weeks
Subjects in both arms will receive Screen for Child Anxiety and Related Disorders (SCARED) instrument upon enrollment (baseline) and at study completion (12 weeks). This instrument is scored from 0 to 82 (2 points per question) and provides a measure of anxiety, avoidance, and panic disorders. Higher scores indicate greater anxiety and related disorders. It was developed by Boris Birmaher, MD, Suneeta Khetarpal, MD, Marlane Cully, MEd, David Brent, MD, and Sandra McKenzie, PhD, Western Psychiatric Institute and Clinic, University of Pittsburgh.
5 secondary outcomes
System Usage
Time frame: 12 Weeks
System Usability Scales
Time frame: 12 Weeks
Child and Adolescent Trauma Screen (CATS)
Time frame: Baseline
Barriers to Treatment Participation Scale (BTPS)
Time frame: Baseline
Digital Competence Scale
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Dziorny, MD, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive Behavioral Therapy in people with Critical Illness Recovery and Mental Health, run by University of Rochester 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 Oct 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.
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 Adam Dziorny, MD, PhD (585-276-3014, adam_dziorny@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen for Child Anxiety and Related Disorders (SCARED) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.