Dementiadementia careNCT07004348
Animation-based Storytelling Education in Relation to Moral Development in 8-12 Year Olds With Dementia-affected Caregivers
An observational study of Dementia, run by Northumbria University at 1 site in United Kingdom.
Trial summary
This retrospective, single-blind, parallel group study investigates the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Animation group will receive 4 sessions of animation as education media as intervention.
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 25 Apr 2025
- Phase
- Observational
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: young people in the community
Who may be able to join
- full time students in public education. Live with family members who have dementia. Can keep attention for a 15-min animation
Who cannot join
- any major neurological illness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle, Newcastle upon Tyne, NE7 7XA.
About this study
This retrospective, single-blind, parallel group study investigates the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.
Read the detailed description
With the measure of moral reasoning and empathy-related traits to investigate the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.
- Conditions
- Dementia
- Being tested
- Animation group will receive 4 sessions of animation as education media as intervention.
- Keywords
- young people, caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation group will receive 4 sessions of animation as education media as intervention.Other
Wait list group will receive the conventional session of education
| Study group | Role | What they receive |
|---|---|---|
| Animation group and wait-list group | Animation group will receive 4 sessions of animation as education media as intervention. Wait list group will receive the conventional session of education Receives: Other: Animation group will receive 4 sessions of animation as education media as intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Chinese Prosocial Reasoning Objective Measure (PROM) was used to assess children's moral reasoning. The PROM presents five stories and asks participants to rate the importance of various reasons for helping or not helping in these ethical dilemmas sc
The Chinese Prosocial Reasoning Objective Measure (PROM) was used to assess children's moral reasoning. The PROM presents five stories and asks participants to rate the importance of various reasons for helping or not helping in these ethical dilemmas scenarios.
Measured: baseline and 1 week after intervention
Secondary outcomes (1)
The Chinese interpersonal reactivity index(C-IRI)
The Chinese interpersonal reactivity index(C-IRI) is a 21-item self- reported questionnaire measuring empathy-related responses and it has three subscales of personal distress, empathy, and fantasy scale
Measured: baseline and 2 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Sep 2021
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Frank Lai, Northumbria University
- Investigators
- Frank Lai, Phd, Principal investigator, The Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004348
- Sponsor's protocol ID
- Northumbria
- Acronym
- dementia care
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animation-based Storytelling Education in Relation to Moral Development in 8-12 Year Olds With Dementia-affected Caregivers
- ClinicalTrials.gov ID
- NCT07004348
- Acronym / sponsor ID
- dementia care / Northumbria
- Conditions
- Dementia
- Keywords
- young people, caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 4 Jun 2025 (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.
This retrospective, single-blind, parallel group study investigates the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.
Detailed description
With the measure of moral reasoning and empathy-related traits to investigate the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Animation group and wait-list group | – | Other: Animation group will receive 4 sessions of animation as education media as intervention.Animation group will receive 4 sessions of animation as education media as intervention. Wait list group will receive the conventional session of education |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- young people in the community
Key inclusion criteria (1 listed)
- full time students in public education. Live with family members who have dementia. Can keep attention for a 15-min animation
Key exclusion criteria (1 listed)
- any major neurological illness
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 |
|---|---|---|
| Animation group will receive 4 sessions of animation as education media as intervention.Wait list group will receive the conventional session of education | Other | Animation group and wait-list group |
Primary outcome
The Chinese Prosocial Reasoning Objective Measure (PROM) was used to assess children's moral reasoning. The PROM presents five stories and asks participants to rate the importance of various reasons for helping or not helping in these ethical dilemmas sc
Time frame: baseline and 1 week after intervention
The Chinese Prosocial Reasoning Objective Measure (PROM) was used to assess children's moral reasoning. The PROM presents five stories and asks participants to rate the importance of various reasons for helping or not helping in these ethical dilemmas scenarios.
1 secondary outcome
The Chinese interpersonal reactivity index(C-IRI)
Time frame: baseline and 2 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- 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.
Frank Lai, Phd principal investigator
The Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Northumbria University at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 4 Jun 2025. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chinese Prosocial Reasoning Objective Measure (PROM) was used to assess children's moral reasoning. The PROM presents five stories and asks participants to rate the importance of various reasons for helping or not helping in these ethical dilemmas sc (time frame: baseline and 1 week after intervention). 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 4 Jun 2025.