Evaluating an eHealth Solution for Screening in Pediatric Care

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Stress Disorders, Post-Traumatic; Pain

Treatments: Behavioral: eScreen system

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04506294

R42HD087021 (U.S. NIH Grant/Contract)

20-017351

Details and patient eligibility

About

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.

Full 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).

Enrollment: 320 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

eScreen Group

Experimental group

Description:

After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks.

Treatment:

Behavioral: eScreen system

Usual Care Group

No Intervention group

Description:

Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment (\~12 weeks)