Clinical trial NCT04506294: Evaluating an eHealth Solution for Screening in Pediatric Care
Official title: Evaluating an eHealth Solution for Screening in Pediatric Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Stress Disorders, Post-Traumatic
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Kentucky
name: Radiant Creative Group, LLC
First posted: 2020-08-10
Enrollment: 320
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will evaluate the predictive validity of a game-based screening system based on child self-report measures.

The core study hypotheses are that (1) in-game assessments will predict problematic recovery (child pain and posttraumatic stress symptoms \[PTSS\]) and (2) parents in the intervention group will report greater confidence in managing child recovery.

Detailed description: This study will evaluate the predictive validity of a game-based screening system based on child self-report measures.

The core study hypotheses are that (1) in-game assessments will predict problematic recovery (child pain and PTSS) and (2) parents in the intervention group will report greater confidence in managing child recovery.

Study Design:

This study is a randomized controlled trial that will examine validity of eScreen measures (primary aim) and assess the impact of the eScreen system on parent confidence in managing child symptoms and recovery (secondary aim).

At T1, after baseline assessment (questionnaires), children will be randomized to the usual care plus eScreen (eScreen) or usual care alone (Usual Care) groups. In the eScreen group, children will use the game-based screening component and parents the parent information component for 6 weeks. All participants will complete follow-up research assessments by phone, online, or mail at T2 (6 weeks) and T3 (12 weeks). Following their T3 research assessment, child participants in the Usual Care group will have the option to play and provide feedback on the game (with no in-game assessment and no parent information component).

Eligibility criteria: Inclusion Criteria:

* Child treated or admitted for injury or illness event that occurred within the past month
* Child has regular access to a compatible (IOS or Android) tablet at home
* Parent has an internet-capable smartphone and can receive text messages on that phone, OR has email account that can receive messages about child status
* Child and parent read or understand English well enough to consent / assent to participation and complete study tasks (e.g., checklists, use of screening system)

Exclusion Criteria:

* Index medical event is due to family violence

Primary outcomes:
measure: Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks
timeFrame: 6 weeks
measure: Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks
timeFrame: 6 weeks
measure: Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks
timeFrame: 6 weeks
measure: Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Kentucky Children's Hospital
state: Kentucky
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Center for Injury Research & Prevention, Children's Hospital of Philadelphia
name: Nancy Kassam-Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kassam-Adams N, Kohser KL, McLaughlin J, Winston F, Marsac ML. Evaluating the Acceptability and Validity of Assessing Pain and Posttraumatic Stress Symptoms in an Adaptable eHealth System for School-Age Children. Clin Pract Pediatr Psychol. 2019 Mar;7(1):9-19. doi: 10.1037/cpp0000261.