Power of Play Study
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?
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Isabella M Viducich, Master of Social Welfare
- 電話番号:7247993926
- メール:viduc001@umn.edu
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55413
- M Health Fairview Masonic Children's Hospital
-
コンタクト:
- Mikaela Olson, Masters in Child Life
- メール:Mikaela.Olson@fairview.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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. |
|
実験的: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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parent-Reported Child Anxiety as assessed using the Spence Preschool Anxiety Scale
時間枠: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
時間枠: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
時間枠: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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parent-Reported Psychological Distancing
時間枠: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
時間枠: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).
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Stephanie M Carlson, Developmental Psychology PhD、Institute of Child Development, University of Minnesota Twin Cities
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ICD-2026-35363
- 35363 (その他の識別子:University of Minnesota Clinical and Translational Science Institute (CTSI))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。