小児臨床試験に関する親リソース

実験的：小児臨床試験（PCT）ポケットガイド

参加者は事前評価と事後評価の間に介入にアクセスできます。 この介入であるPCTポケットガイドは、保護者が小児臨床試験について学び、自身と子供の将来の小児臨床試験への参加に関する意思決定を情報に基づいて行えるように設計された、オンラインのインタラクティブなリソースです。

行動：小児臨床試験（PCT）ポケットガイド

保護者は、小児臨床試験に関する情報を提供するマルチメディア教育リソースと対話し、参加者の権利と安全性、役割、家族・研究者・医療提供者とのコミュニケーションに関するトピックを含み、共有意思決定のための戦略を提供します。

アクティブコンパレータ：活性対照リソース

親御様は、小児臨床試験に関する記事や動画を含む、かつてNIHが支援したウェブサイト（Children and Clinical Studies）のコンテンツにアクセスできます。

行動：活性対照リソース

保護者は、小児臨床試験に関する記事やビデオを含む、元NIH支援ウェブサイト（Children and Clinical Studies）のコンテンツにアクセスできます。

Change From Baseline in Knowledge About Clinical Trials at Week 3

Parents will respond to 8 questions that will assess their factual knowledge about pediatric clinical research (e.g., What does giving 'assent' mean?). Questions are in multiple choice format (some questions have multiple correct answers), and the total score could range from 0-19 correct. Higher scores indicate more knowledge about clinical research.

Change From Baseline in Attitudes About Clinical Trials at Week 3

Parents will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about children and teens participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate more positive attitudes toward clinical trials.

Change From Baseline in Beliefs About Clinical Trials at Week 3

Parents will be asked to respond to 5 questions about their beliefs about pediatric clinical trials (e.g., I believe that clinical trials are safe for children and teens.; 1=Strongly disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly agree). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate more positive beliefs about clinical trials.

Change From Baseline in Likelihood of Participation at Week 3

Parents will be asked to respond to one question about the likelihood of allowing their child to participate in a clinical trial (i.e., If your child were asked to be in a clinical trial, how likely would you be to let them participate?; 1 = Not likely; 2 = Somewhat likely; 3 = Moderately likely; 4 = Very likely; 5 = Extremely likely). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater likelihood of allowing child to participate in a clinical trial.

Change From Baseline in Likelihood of Fear Preventing Participation at Week 3

Parents will be asked to respond to one question about the likelihood of their fear preventing them from allowing their child to participate in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from allowing your child to participate in a clinical trial in the future?; 1 = Not likely; 2 = Somewhat likely; 3 = Moderately likely; 4 = Very likely; 5 = Extremely likely). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater likelihood of fear preventing participation in a clinical trial.

Change From Baseline in Familiarity With Clinical Trials at Week 3

Parents will be asked to respond to one question about their familiarity with clinical trials [How much do you know about pediatric clinical trials (research studies with children under 18; 1 = I don't know anything about them; 2 = I know a little about them; 3 = I know some things about them; 4 = I know a lot about them; 5 = I know all there is to know about them]. Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater familiarity with pediatric clinical trials.

Change From Baseline in Willingness to Participate at Week 3

Parents will review up to five research protocols related to a fictitious disease ('meditis') and respond to questions about their willingness to let their child participate in each research study (i.e., "If your child had meditis, would you agree to enroll them in this study?"; 1 = Definitely not to 7 = Definitely yes). Responses will be averaged across the five protocols and the minimum scale score is 1 and the maximum scale score is 7. Higher scores indicate greater willingness to allow their child to participate in the research studies.

Change From Baseline in Decision Self-efficacy at Week 3

Parents will be asked to respond to 11 questions about their confidence in obtaining information, asking questions, and making an informed decision about their child's participation in a clinical trial (e.g., Get the facts about the risk and side effects of each choice.; 0 = Not at all confident; 4 = Very confident). Responses will be averaged and the minimum scale score is 0 and the maximum scale score is 4. Higher scores indicate greater decision self-efficacy.

Change From Baseline in Research Trust/Mistrust at Week 3

Parents will be asked to respond to 10 questions regarding their trust/mistrust in research (My attitude towards medical research can best be described as positive.; 1 = Strongly disagree; 4 = Strongly agree). The measure has four factors: General Trustworthiness; Perception of Deception; Perception of Exploitation; and Perception of Discriminatory Treatment. Responses will be averaged across each factor and the minimum scale score is 1 and the maximum scale score is 4. Higher scores indicate greater general trustworthiness, greater perceptions of deception, greater perceptions of exploitation, and greater perceptions of discriminatory treatment.