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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name