Using a Cartoon Questionnaire to Improve Consent of Children

Child Development Clinical Trial

Official title:

Using a Cartoon Questionnaire to Improve Consent of Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179240
• Other study ID #: SCMCIRB-K2016069
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Shijian Liu
• Phone: 86-21-38625637
• Email: liushijian[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, a prospective, multicenter, randomized, and controlled trial will be performed to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation.

Description:

In this study, we will evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation. A prospective, multicenter, randomized, and controlled trial will be performed at some hospitals in China. Three hundred children will be randomly asked to participate in our survey to investigate the participants' willingness and attitudes for donating biospecific nonspecimen specimen.The participants will be randomly allocated to the AACQ group and the text questionnaire (TQ) group. A separate knowledge test to assess the amount of knowledge acquired is included in the questionnaires. Additionally, participants' demographic data and basic information will be also collected. In our present study, we aim to test whether an audio and animated cartoon could help the child to understand the information about our research of biospecific nonspecimen specimen donation, reduce differences in their understanding, and use that information to make an appropriate decision for themselves. Meanwhile, we will exam factors that may influence a Chinese child's willingness to donate biospecific nonspecimen specimen before pediatric surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients without obvious communication difficulties in the pediatric surgery wards were invited to participate in this survey.

Exclusion Criteria:

• Patients with obvious communication difficulties

Related Conditions & MeSH terms

• Child Development
• Ethics, Narrative

Intervention

Other:
• audio and animated cartoon questionnaire
participants were asked to complete a questionnaire audio and animated cartoon on a platform

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correction rates	A knowledge test to assess the acquired comprehension of biospecific nonspecimen specimens donated was given at the end of the questionnaire	1 hour after completing the questionnaire
Primary	attitudes toward biospecific nonspecimen specimens	children's attitudes toward whether they would like to donate a particular kind of biospecific nonspecimen specimens	1 hour after completing the questionnaire