PainNCT04506294

Evaluating an eHealth Solution for Screening in Pediatric Care

A study testing eScreen system in people with Pain and Stress Disorders, Post-Traumatic, run by Children's Hospital of Philadelphia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Pain, Stress Disorders, Post-Traumatic
What is being tested?: eScreen system
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 2 sitesUnited States
Study dates: 17 Mar 2021to 21 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

Index medical event is due to family violence

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Kentucky Children's Hospital
Lexington, Kentucky, 40536
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

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.

Read the 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).

Conditions: Pain, Stress Disorders, Post-Traumatic
Being tested: eScreen system
Medical subject headings: Pain, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eScreen systemBehavioural
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.

Study groups in NCT04506294
Study group	Role	What they receive
eScreen Group	Experimental	After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks. Receives: Behavioral: eScreen system
Usual Care Group	No intervention	Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment (~12 weeks)

What is being measured

The primary outcome is the main question the study is designed to answer.

Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting rating >= 6 on 6-week Numerical Rating Scale for Pain Intensity (NRSI)
Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location.
Pain severity at 6 weeks: NRSI >= 6 Verbally-administered, child rates pain by choosing integer from 0 to 10 "where 0 = no pain or hurt and 10 = the most or worst pain/hurt" Rating >=6 validated as clinically significant.
Measured: 6 weeks
Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting T score >= 65 on 6-wk PROMIS Pain Interference scale Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location.
Pain interference at 6 weeks: PROMIS Pediatric Pain Interference T score >=65 Brief questionnaire - Child rates pain interference with daily activities over past 7 days. Ratings lead to normed T scores where >=65 = significant interference.
Measured: 6 weeks
Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether child meets symptom criteria for posttraumatic stress disorder (PTSD) on 6-wk Child PTSD Symptom Scale for DSM-5 [CPSS-5] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity.
Child PTSD Symptom Scale for DSM-5 (CPSS-5) 20-item questionnaire assesses DSM-5 criteria for posttraumatic stress disorder (PTSD), scored here to determine whether child meets symptom criteria for PTSD at 6 wks.
Measured: 6 weeks
Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether or not child reports impairment from posttraumatic stress symptoms (PTSS) on 6-wk Child PTSD Symptom Scale for DSM-5 [CPSS-5] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity.
Child PTSD Symptom Scale for DSM-5 (CPSS-5) 7 items in the CPSS questionnaire assess impairment (in social/interpersonal or academic functioning or daily activities) related to posttraumatic stress symptoms. Impairment scored as present if child endorses impairment on any item at 6 wks.
Measured: 6 weeks

Secondary outcomes (1)

Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery
Examine difference between eScreen and usual care groups on parents' self-rated confidence (at 6 weeks) related to managing child symptoms and recovery after discharge.
Parent Confidence Scale - 9 Likert-scale items in which parents rate (from 1 to 5) the extent to which they have felt prepared to manage their ill or injured child's symptoms and recovery after hospital or clinic discharge. Summed total scores range from 5 to 45, higher scores indicate greater confidence.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 202121 Jul 2022

First posted10 Aug 2020
Study start17 Mar 2021
Primary completion21 Jul 2022
Study completion21 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04506294
Sponsor's protocol ID: 20-017351
Other IDs: R42HD087021
Status last verified: May 2024
First submitted: 15 Jul 2020
Last updated: 26 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Will share de-identified individual participant data, at minimum including key variables relevant to describing participants and assessing primary and secondary outcomes.

Publications

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.
PubMed 31275781

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating an eHealth Solution for Screening in Pediatric Care
ClinicalTrials.gov ID: NCT04506294
Acronym / sponsor ID: 20-017351
Conditions: Pain, Stress Disorders, Post-Traumatic
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Kentucky, Radiant Creative Group, LLC
Study start: 17 Mar 2021 (actual)
Primary completion: 21 Jul 2022 (actual)
Study completion: 21 Jul 2022 (actual)
First posted: 10 Aug 2020 (actual)
Results: Posted 26 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study Design:

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
eScreen Group	Experimental	Behavioral: eScreen systemAfter randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks.
Usual Care Group	No intervention	–Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment (~12 weeks)

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (1 listed)

Index medical event is due to family violence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
eScreen systemThe 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.	Behavioural	eScreen Group

Primary outcome

Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks
Time frame: 6 weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting rating >= 6 on 6-week Numerical Rating Scale for Pain Intensity (NRSI) Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location. Pain severity at 6 weeks: NRSI >= 6 Verbally-administered, child rates pain by choosing integer from 0 to 10 "where 0 = no pain or hurt and 10 = the most or worst pain/hurt" Rating >=6 validated as clinically significant.
Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks
Time frame: 6 weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting T score >= 65 on 6-wk PROMIS Pain Interference scale Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location. Pain interference at 6 weeks: PROMIS Pediatric Pain Interference T score >=65 Brief questionnaire - Child rates pain interference with daily activities over past 7 days. Ratings lead to normed T scores where >=65 = significant interference.
Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks
Time frame: 6 weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether child meets symptom criteria for posttraumatic stress disorder (PTSD) on 6-wk Child PTSD Symptom Scale for DSM-5 [CPSS-5] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity. Child PTSD Symptom Scale for DSM-5 (CPSS-5) 20-item questionnaire assesses DSM-5 criteria for posttraumatic stress disorder (PTSD), scored here to determine whether child meets symptom criteria for PTSD at 6 wks.
Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks
Time frame: 6 weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether or not child reports impairment from posttraumatic stress symptoms (PTSS) on 6-wk Child PTSD Symptom Scale for DSM-5 [CPSS-5] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity. Child PTSD Symptom Scale for DSM-5 (CPSS-5) 7 items in the CPSS questionnaire assess impairment (in social/interpersonal or academic functioning or daily activities) related to posttraumatic stress symptoms. Impairment scored as present if child endorses impairment on any item at 6 wks.

1 secondary outcome

Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery
Time frame: 6 weeks

Results and safety

Results posted to the registry on 26 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
eScreen Group	214	128
Usual Care Group	106	84

Primary outcome: Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks

Time frame: 6 weeks

Population analysed: At 6 weeks no children reported NRSI \>=6 (ie clinically significant pain, thus planned analyses could not be conducted.

Primary outcome: Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: Probability

Measure	eScreen Group n = 45	Usual Care Group n = 0
Value	.756 (.613 to .900)	–

Population analysed: This outcome pertains only to children (not parents); only in the eScreen group.

Primary outcome: Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: Probability

Measure	eScreen Group n = 44	Usual Care Group n = 0
Value	.822 (.650 to .994)	–

Population analysed: This outcome pertains only to child participants, and only to those in eScreen group.

Primary outcome: Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: Probability

Measure	eScreen Group n = 44	Usual Care Group n = 0
Value	.691 (.531 to .850)	–

Population analysed: This outcome pertains only to child participants, and only to those in the eScreen group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
eScreen Group	0 of 214 (0%)	0 of 214 (0%)	0 of 214
Usual Care Group	0 of 106 (0%)	0 of 106 (0%)	0 of 106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31275781Kassam-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.
Individual participant dataSharing planned: Yes. Will share de-identified individual participant data, at minimum including key variables relevant to describing participants and assessing primary and secondary outcomes.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy Kassam-Adams, PhD principal investigator

Center for Injury Research & Prevention, Children's Hospital of Philadelphia

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing eScreen system in people with Pain and Stress Disorders, Post-Traumatic, run by Children's Hospital of Philadelphia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04506294, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.