Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT04506294
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating an eHealth Solution for Screening in Pediatric Care
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Evaluating an eHealth Solution for Screening in Pediatric Care
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R42HD087021 | NIH | None | https://reporter.nih.gov/quic… | View |