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Power of Play Study

5 de novembro de 2026 atualizado por: University of Minnesota

The Power of Play: Evaluating an Imagination-Inspired Medical Garment for Children

This project will evaluate whether SuperTee, an imaginative hospital gown designed to help children embody empowering characters (e.g., superheroes), can reduce anxiety and improve coping skills among young children receiving hospital care.

Research Question 1: Is receiving the SuperTee garment associated with lower parent-reported levels of children's anxiety compared to baseline?

Research Question 2: Does receiving the SuperTee garment promote improvements in parent-reported levels of children's coping skills compared to baseline?

This study will also investigate the initial feasibility of SuperTee, as well as a potential mechanism through which it works (psychological distancing) .

Secondary Question 1: Do parent-reported levels of their child's ability to psychologically distance themselves from difficult situations explain differences in children's responses to the SuperTee intervention?

Secondary Question 2: Do parents and children like the SuperTee medical garment and find it to be practical and easy to use? How often do the children use it?

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Descrição detalhada

Hospitalization can be highly distressing for children, particularly those with chronic illness who experience repeated medical visits. This project will evaluate the initial effectiveness and feasibility of the SuperTee medical garment, an imaginative hospital gown designed to help children embody empowering characters (e.g., superheroes), in reducing anxiety and improving coping skills while receiving hospital care.

The project will use a randomized controlled design involving children ages 4-7 years receiving treatment at M Health Fairview Masonic Children's Hospital. Participants will be randomly assigned to an intervention or a waitlist group. In both groups, parents will complete surveys before and after the intervention assessing children's anxiety and coping skills and provide qualitative feedback about their child's experience with their SuperTee.

This study will provide the first empirical test of a cost-effective, portable, imagination-based intervention for reducing anxiety and promoting coping skills in this population without requiring trained personnel. If successful, this work would establish a foundation for larger-scale trials and could improve these children's quality of life.

Tipo de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Isabella M Viducich, Master of Social Welfare
  • Número de telefone: 7247993926
  • E-mail: viduc001@umn.edu

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

4 anos a 7 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • The study participants will be children, aged 4-7 years, undergoing medical treatment at the Fairview Masonic Children's Hospital in Minneapolis, MN for chronic health conditions.

Exclusion Criteria:

  • Children who do not speak English, have an intellectual disability, have uncorrected vision or hearing disabilities, are terminally ill or do not have access to a smartphone, tablet, or computer that is able to run online surveys will be excluded from the final study sample.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: SuperTee Condition

Two weeks before their child's next hospital visit, Qualtrics surveys will be sent to participants' parent/guardian to capture baseline values of the dependent variables, demographic characteristics, and illness severity information. During the scheduled hospital visit, a member of the study team will be present to administer the SuperTee intervention. The child will receive their SuperTee, will be given time to play with it freely, and then will be guided through an imaginal exercise to encourage them to begin to embody their character. Following the intervention, participants' parents will receive bi-weekly text messages sent via the Mosio platform reminding them to encourage their child to wear their SuperTee. After 6 weeks, a follow-up survey will be sent to capture change on the dependent variables, feedback on the SuperTee (from parent and child), and frequency of use. After an additional 6 weeks, parents will complete a survey version of the dependent variables one final time.

The intervention will utilize the SuperTee medical garment. Each garment, in addition to being Magnetic Resonance Imaging safe and medically accessible, is designed to encourage children to embody an inspiring character, with options including a ballerina, a space commander, and Marvel superhero characters (Spiderman, Captain America, and Captain Marvel). These medical garments, which are donated to hospitals by the Fair Fight Foundation, are a relatively low-cost, portable, and easy to implement intervention for children who are undergoing a hospitalization.

Experimental: SuperTee Waitlist Condition

This arm is the same as the Intervention arm, except they will have a delayed start to receiving the SuperTee intervention.

The intervention will utilize the SuperTee medical garment. Each garment, in addition to being Magnetic Resonance Imaging safe and medically accessible, is designed to encourage children to embody an inspiring character, with options including a ballerina, a space commander, and Marvel superhero characters (Spiderman, Captain America, and Captain Marvel). These medical garments, which are donated to hospitals by the Fair Fight Foundation, are a relatively low-cost, portable, and easy to implement intervention for children who are undergoing a hospitalization.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Parent-Reported Child Anxiety as assessed using the Spence Preschool Anxiety Scale
Prazo: 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).

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).
Parent-Reported Child Coping Skills as assessed using the Children's Coping Scale- Revised
Prazo: 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).

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).
Parent-Reported Child Anxiety as assessed using the Spence Preschool Anxiety Scale
Prazo: 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).

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).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Parent-Reported Psychological Distancing
Prazo: Parents 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.

Parents 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).
Measures to Guage Parent/Child Reaction to SuperTee
Prazo: Parents 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.

Parents 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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Stephanie M Carlson, Developmental Psychology PhD, Institute of Child Development, University of Minnesota Twin Cities

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de dezembro de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

14 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de novembro de 2026

Primeira postagem (Real)

9 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • ICD-2026-35363
  • 35363 (Outro identificador: University of Minnesota Clinical and Translational Science Institute (CTSI))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

De-identified data will be shared upon reasonable request. Because this research is testing a novel and exploratory research question, we do not have plans to upload the data to a repository at this time.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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