Evaluating an eHealth Solution for Screening in Pediatric Care

Pain Clinical Trial

Official title:

Evaluating an eHealth Solution for Screening in Pediatric Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506294
• Other study ID #: 20-017351
• Secondary ID: R42HD087021
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: July 21, 2022

Study information

• Verified date: January 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• eScreen system
The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.

Locations

Country	Name	City	State
United States	Kentucky Children's Hospital	Lexington	Kentucky
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Radiant Creative Group, LLC, University of Kentucky

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive validity of eScreen pain measure for clinically significant pain severity at 6 weeks	Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain intensity (score >=6 on the Numerical Rating Scale; NRSI) at 6 weeks.	6 weeks
Primary	Predictive validity of eScreen pain measure for clinically significant pain interference at 6 weeks	Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain interference (T score >=65 on the PROMIS Pediatric Pain Interference scale - child report) at 6 weeks.	6 weeks
Primary	Predictive validity of eScreen posttraumatic stress measure for clinically significant posttraumatic stress symptoms at 6 weeks	Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of clinically significant posttraumatic stress symptoms at 6 weeks, scored from symptom count on the Child PTSD Symptom Scale for DSM-5 [CPSS-5].	6 weeks
Primary	Predictive validity of eScreen posttraumatic stress measure for impairment from posttraumatic stress symptoms at 6 weeks	Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of impairment from posttraumatic stress symptoms at 6 weeks, scored from impairment items on the Child PTSD Symptom Scale for DSM-5 [CPSS-5].	6 weeks
Secondary	Impact of eScreen system on parent confidence in managing child symptoms and recovery	Examine difference between (randomly assigned) eScreen and usual care groups on a measure of parents' self-rated confidence in managing child symptoms and recovery. Effect size (Cohen's d) calculated as the between-group difference in summed ratings on the Parent Information / Confidence Questionnaire, standardized by the pooled standard deviation (SD) for the groups.	6 weeks