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Power of Play Study

NCT07926984, Not applicable, Not yet recruiting, University of Minnesota

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitlePower of Play StudyClinicalTrials.gov
NCT numberNCT07926984ClinicalTrials.gov
StatusNot yet recruitingClinicalTrials.gov
PhasesNot applicableClinicalTrials.gov
Enrollment90 participants, estimatedClinicalTrials.gov
Lead sponsorUniversity of MinnesotaClinicalTrials.gov
ConditionsHospitalization in ChildrenClinicalTrials.gov
InterventionsSuperTeeClinicalTrials.gov
First posted2026-11-09ClinicalTrials.gov
Last updated2026-11-09ClinicalTrials.gov

Registered outcomes 5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryParent-Reported Child Anxiety as assessed using the Spence Preschool Anxiety Scale
SuperTee intervention group: Parents will complete this scale in weeks 1, 9, and 15 (intervention occurs in week 3). SuperTee waitlist group: Parents will complete this scale in weeks 1, 7, and 15 (intervention occurs in week 9).
Parents will be asked to describe if a series of statements "never," "sometimes," "often," or "always" describe their child. Example items include "my child worries about things" and "my child is scared of the dark." This scale generates a sum score; participants' sum scores from different time points will be compared. Sum scores can range from 0 (low anxiety/better outcome) to 114 (high anxiety/worse outcome).
ClinicalTrials.gov
PrimaryParent-Reported Child Coping Skills as assessed using the Children's Coping Scale- Revised
SuperTee intervention group: Parents will complete this scale in weeks 1, 9, and 15 (intervention occurs in week 3). SuperTee waitlist group: Parents will complete this scale in weeks 1, 7, and 15 (intervention occurs in week 9).
Parents will be asked to describe how frequently their child uses a number of both positive and negative coping strategies, with response options comprising "never," "sometimes," or "a lot." All coping strategies are asked about within three different contexts: in general, when saying goodbye, and when the child has to do something that they do not want to do. Positive coping strategies include "spend a lot of time with a good friend" and "ask a teacher for help." Negative example coping strategies, which are reverse-coded, include "keep feelings to self/not show how he/she feels" and "get stomach aches or headaches." A sum-score will also be generated from this scale; participants' sum scores from different time points will be compared. Sum scores can range from 0 (weaker parent-reported coping skills/worse outcome) to 174 (stronger parent-reported coping skills/better outcome).
ClinicalTrials.gov
PrimaryParent-Reported Child Anxiety as assessed using the Spence Preschool Anxiety Scale
For the SuperTee Intervention group, parents will complete this scale for their child 2 weeks before they receive their SuperTee (8 and 2 weeks for waitlist). They will also complete this scale 6 & 12 weeks after the intervention (6 weeks for waitlist).
Parents will be asked to describe if a series of statements "never," "sometimes," "often," or "always" describe their child. Example items include "my child worries about things" and "my child is scared of the dark." This scale generates a sum score; participants' sum scores from different time points will be compared. Sum scores can range from 0 (low anxiety/better outcome) to 114 (high anxiety/worse outcome).
ClinicalTrials.gov
SecondaryParent-Reported Psychological DistancingParents will complete this scale 6 weeks after their child receives the SuperTee intervention (week 9 for the SuperTee intervention group, week 15 for the SuperTee waitlist group).
Because no existing developmentally appropriate measure of psychological distancing was identified, to investigate the proposed mechanism, the study team has created an exploratory quantitative measure asking parents to report on how much their child engages in various psychological distancing behaviors when facing a difficult medical situation. For example, one item asks: "When my child is facing a difficult medical situation, they look at the situation from the outside and separate themselves from what is happening." The study team has written several items to help establish the reliability of this measure, all of which will be endorsed on a 4-point scale. An average score on the items of this scale will be created for each participant. Thus, average scores on this scale will range between 0-4 , with higher scores corresponding to higher parent-reported psychological distancing.
ClinicalTrials.gov
SecondaryMeasures to Guage Parent/Child Reaction to SuperTeeParents will also complete this scale 6 weeks after their child receives the SuperTee intervention (week 9 for the SuperTee intervention group, week 15 for the SuperTee waitlist group).
The study team has also created a measure to gauge parent and child reactions to the SuperTee medical garment. Parents will be asked to respond to 8 items measured on a 4-point scale, such as "My child wanted to wear the SuperTee during their hospital visit." An average score on the items of this scale will be created for each participant. Thus, average scores on this scale will range between 0-4 , with higher scores corresponding to higher parent-reported satisfaction with SuperTee. Parents will also be asked to report, on average, how many days per week their child wore their SuperTee. Parents will be asked to reply to one open-ended item ("Please use this space to write anything that you would like for our team to know about your child's experience using SuperTee"). Parents will also be instructed to ask their children four open-ended questions (e.g., "What did you pretend when you wore your SuperTee?") and will be asked to type their child's responses to these questions.
ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)