Using a Cartoon Questionnaire to Improve Consent of Children

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT04179240

Collaborator

(none)

300

Enrollment

Location

Arms

11.1

Anticipated Duration (Months)

26.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Child Development Ethics, Narrative	Other: audio and animated cartoon questionnaire	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 26, 2019

Anticipated Primary Completion Date :

Aug 31, 2020

Anticipated Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: audio and animated cartoon questionnaire group After a brief introduction to our survey, participants(children) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with audio and animated cartoon questionnaire. The animation was an 8-minute cartoon video divided into different parts according to different questions. The first part of the animation was the introduction of biospecific nonspecimen specimen and our survey, while the other parts showed the content of the questionnaire about donating biospecific nonspecimen specimen in a vivid way. The background music built a relaxed and pleasant atmosphere, and some cartoon pictures were made into question options to simplify the understanding and data analysis.	Other: audio and animated cartoon questionnaire participants were asked to complete a questionnaire audio and animated cartoon on a platform
No Intervention: text questionnaire group After a brief introduction to our survey, participants(children) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with text questionnaire.
Other: Parent group After a brief introduction to our survey, participants(parent) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with text questionnaire.	Other: audio and animated cartoon questionnaire participants were asked to complete a questionnaire audio and animated cartoon on a platform

Arm

Intervention/Treatment

Experimental: audio and animated cartoon questionnaire group

After a brief introduction to our survey, participants(children) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with audio and animated cartoon questionnaire. The animation was an 8-minute cartoon video divided into different parts according to different questions. The first part of the animation was the introduction of biospecific nonspecimen specimen and our survey, while the other parts showed the content of the questionnaire about donating biospecific nonspecimen specimen in a vivid way. The background music built a relaxed and pleasant atmosphere, and some cartoon pictures were made into question options to simplify the understanding and data analysis.

Other: audio and animated cartoon questionnaire

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

No Intervention: text questionnaire group

After a brief introduction to our survey, participants(children) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with text questionnaire.

Other: Parent group

After a brief introduction to our survey, participants(parent) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with text questionnaire.

Other: audio and animated cartoon questionnaire

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

Outcome Measures

Primary Outcome Measures

correction rates [1 hour after completing the questionnaire]
A knowledge test to assess the acquired comprehension of biospecific nonspecimen specimens donated was given at the end of the questionnaire
attitudes toward biospecific nonspecimen specimens [1 hour after completing the questionnaire]
children's attitudes toward whether they would like to donate a particular kind of biospecific nonspecimen specimens

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

Principal Investigator: Shijian Liu, Shanghai Children's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sijia Gu, Clinical Professor, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT04179240

Other Study ID Numbers:

SCMCIRB-K2016069

First Posted:

Nov 27, 2019

Last Update Posted:

Dec 2, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sijia Gu, Clinical Professor, Shanghai Jiao Tong University School of Medicine

biospecific nonspecimen specimen

Study Results

No Results Posted as of Dec 2, 2019