The TRAIN Study: A Concussion Prevention Strategy in Middle Schools
Popular Opinion Leaders as a Sports Concussion Prevention Strategy in Middle Schools-The TRAIN Study, a Randomized Control Study
Purpose: The purpose of this study is to evaluate the effectiveness of a theory-driven intervention (TRAIN concussion education) to improve parental concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy.
Participants: 180 parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years.
Procedures: The study is a single-blind (participants) randomized control trial. The investigators will randomize eligible parents into two groups: (1) control (standard concussion education); and treatment (standard concussion education AND TRAIN concussion education) to evaluate the effectiveness of the TRAIN concussion education intervention.
調査の概要
詳細な説明
A convenience sample of participants will be recruited from parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years. Interested parents will contact study stuff, who will ensure eligibility criteria are met.
Upon this, and completing the written informed consent process, participants will be assigned a unique identifier and randomized (simple) without replacement to one of the two study arms (control vs. treatment), using a predetermined random number generator in Excel.
Participants in the control group will receive standard concussion education materials focused on concussion prevention in youth sport. Participants in the treatment group will receive the same standard concussion education materials AND the TRAIN concussion education module. The TRAIN education module is grounded in a theoretical structure inclusive of the original intervention tenants of the Popular Opinion Leader (POL) and Diffusion of Innovations frameworks, and within the context of the socioecological model.
Participants will complete a self-administered online pre-test survey, which includes assessments of concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy. After completion of the pre-test survey, participants will complete their assigned intervention (TRAIN concussion education module + standard concussion education materials versus standard concussion education materials only).
Upon completion of their assigned intervention, participants will complete the online survey again to obtain post-test measures (post-test survey). Participants will also be scheduled to complete individual semi-structured interviews.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27514
- University of North Carolina Injury Prevention Research Center
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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:
- Adult with a child/children enrolled in a United States middle school
- Adult whose child has participated in organized sports in the past 2 years
Exclusion Criteria:
• Adult without a child/children enrolled in a United States middle school
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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アクティブコンパレータ：Standard Concussion Education
Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.
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Participants will receive a standard concussion education module.
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実験的：TRAIN Concussion Education
After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.
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Participants will receive the TRAIN concussion education module.
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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 |
|---|---|---|
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Concussion-Related Beliefs Change Score
時間枠：Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Participants are asked 6 questions concerning beliefs related to concussion risk, symptoms, and management.
These items are added together to compute an overall score.
Scoring scale ranges from a minimum of 6 to a maximum 24, where a higher score indicated more favorable beliefs.
A change score will be computed post score-pre score.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Concussion-Related Attitudes Change Score
時間枠：Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Participants are asked 20 survey items identifying an individual's attitudes about a certain behavior (e.g., seeking care).
Each item is added together to compute an overall attitude score.
Scoring scale ranges from a minimum of 20 to a maximum of 140, where higher scores indicate more favorable attitudes.
A change score will be computed post score-pre score.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Confidence in Concussion-Related Knowledge Change Score
時間枠：Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Participants are asked 2 questions concerning confidence in knowing and recognizing concussion symptoms.
These items are added together to compute an overall score.
Scoring scale ranges from a minimum of 2 to a maximum 8, where a higher score indicated better confidence in concussion knowledge.
A change score will be computed post score-pre score.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Concussion-Related Intentions Change Score
時間枠：Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Participants are asked 4 questions assessing intention to engage in or talk with others about concussion prevention.
The items are totaled to compute an overall behavioral intention score.
Scoring scale ranges from a minimum of 4 to a maximum of 16, where a higher score indicates a better likelihood to engage in favorable behaviors related to concussion prevention.
A change score will be computed post score-pre score.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Concussion-Related Self-Efficacy Change Score
時間枠：Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Participants are asked 8 questions assessing their self-efficacy regarding engaging in or talking with others about concussion prevention.
The items are totaled to compute an overall self-efficacy score.
Scoring scale ranges from a minimum of 8 to a maximum of 32, where a higher score indicates higher self-efficacy.
A change score will be computed post score-pre score.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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協力者と研究者
捜査官
- 主任研究者：Zachary Kerr, PhD, MPH、University of North Carolina, Chapel Hill
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 21-0314
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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