An interventional study of Digital Cognitive Behavioral Therapy in Critical Illness Recovery and Mental Health, sponsored by University of Rochester. Not yet recruiting at 1 site in United States. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Rochester · Not applicable, Interventional, and Supportive care
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.
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.
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This study's planned enrollment of 70 is below the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
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Exclusion Criteria:
Subjects in this arm will be randomized to an online, commercially available, digital cognitive behavioral therapy tool for use following discharge from the hospital.
Other: Digital Cognitive Behavioral Therapy
Subjects in this arm will not receive access to the digital cognitive behavioral therapy tool. They will experience usual post-hospital care.
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.
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.
Time frame: Baseline and 12 weeks
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.
Time frame: 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.
Time frame: 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.).
Time frame: 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.
Time frame: 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).
Time frame: Baseline
Plan to share: No
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