UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039681 |
|---|---|
| Receipt number | R000045260 |
| Scientific Title | Effect of Rational Digital Storytelling Intervention on Depression among Adolescent-Athletes with Special Educational Needs |
| Date of disclosure of the study information | 2020/03/03 |
| Last modified on | 2020/03/03 22:22:41 |
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Basic information
Public title
Effect of Rational Digital Storytelling Intervention on Depression among Adolescent-Athletes with Special Educational Needs
Acronym
Effect of Rational Digital Storytelling Intervention on Depression among Adolescent-Athletes with Special Educational Needs
Scientific Title
Effect of Rational Digital Storytelling Intervention on Depression among Adolescent-Athletes with Special Educational Needs
Scientific Title:Acronym
Effect of Rational Digital Storytelling Intervention on Depression among Adolescent-Athletes with Special Educational Needs
Region
| Africa |
Condition
Condition
Depression
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to determine the effect of a rational digital storytelling intervention on depression among a sample of adolescent-athletes with special educational needs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The Beck Depression Inventory-II (BDI II): Time 1, Time 2, Time 3
Key secondary outcomes
The Child and Adolescent Scale of Irrationality (CASI): Time 1, Time 2, Time 3
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The treatment group participated in the rational digital storytelling intervention, over a twelve-week period whereas the control group was exposed to oral storytelling at precisely the same timeframe, with the meeting sessions holding 2 times weekly.
Interventions/Control_2
Experimental, n=30; Control, n=30
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Prospective participants were included if their self-reported mean depression score was moderate to severe as measured by Beck Depression Inventory-II (BDI-II); completed the informed consent form; and were not currently enrolled in another depression management intervention.
Key exclusion criteria
A prospective participant was considered ineligible for the study if their self-reported mean depression score was normal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Uche |
| Middle name | D. |
| Last name | Asogwa |
Organization
University of Nigeria Nsukka
Division name
Faculty of Education,
Zip code
410001
Address
Faculty of Education, University of Nigeria Nsukka
TEL
08068792704
uche.asogwa@unn.edu.ng
Public contact
Name of contact person
| 1st name | Chiedu |
| Middle name | |
| Last name | Eseadi |
Organization
University of Nigeria Nsukka
Division name
Faculty of Education,
Zip code
410001
Address
Educational Foundations
TEL
08137258914
Homepage URL
chiedu.eseadi@unn.edu.ng
Sponsor or person
Institute
Otusum Consult Training & Services Nigeria
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Education Research Ethics Committee
Address
University of Nigeria Nsukka
Tel
2348157702756
education.faculty@unn.edu.ng
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
depressive symptoms, irrational thinking
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 26 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 26 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045260
