Child DevelopmentNCT04179240
Using a Cartoon Questionnaire to Improve Consent of Children
A study testing audio and animated cartoon questionnaire in people with Child Development and Ethics, Narrative, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Child Development, Ethics, Narrative
- What is being tested?
- audio and animated cartoon questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients without obvious communication difficulties in the pediatric surgery wards were invited to participate in this survey.
Who cannot join
- Patients with obvious communication difficulties
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Shijian Liu, Ph.D, 21-38625637, liushijian@scmc.com.cn
About this study
Official title: Using a Cartoon Questionnaire to Improve Consent of Children: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Child Development, Ethics, Narrative
- Being tested
- audio and animated cartoon questionnaire
- Keywords
- biospecific nonspecimen specimen, child and adolescent, cartoon, questionnaire, concent
- Medical subject headings
- Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audio and animated cartoon questionnaireOther
participants were asked to complete a questionnaire audio and animated cartoon on a platform
| Study group | Role | What they receive |
|---|---|---|
| audio and animated cartoon questionnaire group | Experimental | 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. Receives: Other: audio and animated cartoon questionnaire |
| text questionnaire group | No intervention | 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. |
| Parent group | Other | 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. Receives: Other: audio and animated cartoon questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction rates
A knowledge test to assess the acquired comprehension of biospecific nonspecimen specimens donated was given at the end of the questionnaire
Measured: 1 hour after completing the questionnaire
attitudes toward biospecific nonspecimen specimens
children's attitudes toward whether they would like to donate a particular kind of biospecific nonspecimen specimens
Measured: 1 hour after completing the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start26 Nov 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Shijian Liu, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179240
- Sponsor's protocol ID
- SCMCIRB-K2016069
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Cartoon Questionnaire to Improve Consent of Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04179240
- Acronym / sponsor ID
- SCMCIRB-K2016069
- Conditions
- Child Development, Ethics, Narrative
- Keywords
- biospecific nonspecimen specimen, child and adolescent, cartoon, questionnaire, concent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| audio and animated cartoon questionnaire group | Experimental | Other: audio and animated cartoon questionnaireAfter 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. |
| text questionnaire group | No intervention | –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. |
| Parent group | Other | Other: audio and animated cartoon questionnaireAfter 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients without obvious communication difficulties in the pediatric surgery wards were invited to participate in this survey.
Key exclusion criteria (1 listed)
- Patients with obvious communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audio and animated cartoon questionnaireparticipants were asked to complete a questionnaire audio and animated cartoon on a platform | Other | Parent group, audio and animated cartoon questionnaire group |
Primary outcome
correction rates
Time frame: 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
Time frame: 1 hour after completing the questionnaire
children's attitudes toward whether they would like to donate a particular kind of biospecific nonspecimen specimens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shijian Liu principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing audio and animated cartoon questionnaire in people with Child Development and Ethics, Narrative, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shijian Liu (86-21-38625637, liushijian@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correction rates (time frame: 1 hour after completing the questionnaire). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.