UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040887
Receipt number R000046690
Scientific Title Cognitive Behavioural Language Therapy for Online Hate Speech Experience, and Reduction of Posttraumatic Related Stress Response among Nigerian University Students
Date of disclosure of the study information 2020/06/25
Last modified on 2020/06/24 21:51:17

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Basic information

Public title

Cognitive Behavioural Language Therapy for Online Hate Speech Experience, and Reduction of Posttraumatic Related Stress Response among Nigerian University Students

Acronym

CBLT for Online Hate Speech Experience and Posttraumatic Related Stress Response

Scientific Title

Cognitive Behavioural Language Therapy for Online Hate Speech Experience, and Reduction of Posttraumatic Related Stress Response among Nigerian University Students

Scientific Title:Acronym

CBLT for Online Hate Speech Experience and Posttraumatic Related Stress Response

Region

Africa


Condition

Condition

Online Hate Speech Experience and Posttraumatic Related Stress Response

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Cognitive Behavioural Language Therapy for Online Hate Speech Experience, and Reduction of Posttraumatic Related Stress Response among Nigerian University Students

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Online Hate Speech Scale (OHSS) at Time 1, Time 2 and Time 3
Cyberbullying Coping Questionnaire (CCQ) at Time 1, Time 2 and Time 3
The Survey for Coping with Rejection Experiences (SCORE) at Time 1, Time 2 and Time 3
Trauma-Related Irrational Belief Scale at Time 1, Time 2 and Time 3

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

The participants in intervention group received cognitive behavioural language therapy programme packed with how to overcome and challenge abusive speech. Cognitive behavioral language therapy program (CBLTP) is an 8-program that lasted for two months, one session per week.

Interventions/Control_2

Participants in the comparison group received the treatment after the study.

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

17 years-old <=

Age-upper limit

25 years-old >=

Gender

Male and Female

Key inclusion criteria

Inclusion criteria included, 1) must be a student in any Nigerian university and a Nigerian citizen, 2) must have an account with social networking sites (e.g Twitter, Facebook, YouTube, Whatsapp), 3) willingness to participate, and 4) the language of expression be English.

Key exclusion criteria

The exclusion criteria were 1) foreign students and 2) internet non-compliance.

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Moses
Middle name Onyemaechi
Last name Ede

Organization

University of Nigeria, Nsukka

Division name

Department of Educational Foundations

Zip code

410001

Address

Moses O. Ede, Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria

TEL

07066725165

Email

moses.ede@unn.edu.ng


Public contact

Name of contact person

1st name Moses
Middle name Onyemaechi
Last name Ede

Organization

University of Nigeria, Nsukka

Division name

Department of Educational Foundations

Zip code

410001

Address

Moses O. Ede, Educational Foundations, Faculty of Education.

TEL

07066725165

Homepage URL


Email

moses.ede@unn.edu.ng


Sponsor or person

Institute

Mosco Consult

Institute

Department

Personal name



Funding Source

Organization

University of Nigeria

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Faculty of Education, University of Nigeria

Address

Faculty of Education, University of Nigeria

Tel

+2348137258914

Email

chiedu.eseadi@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 06 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications

Not applicable

Number of participants that the trial has enrolled

110

Results

The results of ANCOVA showed that there is positive study outcomes for the participants in the treatment group compared to the waitlist control group over the 3 periods. Additionally, we found a consistent significant impact of cognitive behavioural language therapy on online hate speech experience, and posttraumatic related stress response among Nigerian university students.

Results date posted

2020 Year 06 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2018 Year 05 Month 11 Day

Baseline Characteristics


Participant flow


Adverse events

There is no adverse events associated with the study

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 04 Month 19 Day

Date of IRB

2018 Year 04 Month 25 Day

Anticipated trial start date

2019 Year 07 Month 18 Day

Last follow-up date

2019 Year 11 Month 25 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2020 Year 01 Month 16 Day

Date analysis concluded

2020 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2020 Year 06 Month 24 Day

Last modified on

2020 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name