UMIN-CTR Clinical Trial

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
Email	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
Email	chiedu.eseadi@unn.edu.ng

Sponsor
Institute	Otusum Consult Training & Services Nigeria
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045260