Condition category
Mental and Behavioural Disorders
Date applied
06/12/2017
Date assigned
24/05/2018
Last edited
24/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The researchers are conducting a study to determine the effectiveness of a school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia. The aim of this study is to find out whether the school-based anxiety prevention program is effective in reducing anxiety symptoms, as well as to improve the participants’ worry coping skill and self-esteem.

Who can participate?
Children aged 10-11 who are attending selected primary schools in Jerantut, Pahang, Malaysia

What does the study involve?
Participants complete an assessment and are randomly allocated to either the intervention group or the control group. Participants in the intervention group attend four sessions of a school-based anxiety prevention program over 4 weeks. After the participants in the intervention group complete all the sessions, the participants in the control group are offered the same program. Participants in both groups are followed up immediately and three months after the program.

What are the possible benefits and risk of participating?
The possible benefits of participating in the study are the participants will be able to know their current anxiety status and increase their worry coping skill and self-esteem. This possibly may help to reduce the symptoms of anxiety. There are no risks involved in this study.

Where is the study run from?
Primary schools in Jerantut, Pahang, Malaysia in collaboration with Universiti Putra Malaysia

Who is funding the study?
Universiti Putra Malaysia

Who is the main contact?
Prof. Dr Sherina Mohd Sidik

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sherina Mohd Sidik

ORCID ID

Contact details

Cancer Resource & Education Centre (CaRE)
Universiti Putra Malaysia
Selangor
43400
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized controlled trial on a school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia

Acronym

Study hypothesis

It is hypothesized that the symptoms of anxiety will reduce in the intervention group as compared to the control group. Worry coping skill and self-esteem of the participants are also expected to improve after the intervention. The null hypothesis is there is no significant difference between the intervention and control groups, in terms of reduction of anxiety symptoms and improvement of worry coping skill and self-esteem.

Ethics approval

University Putra Malaysia, 04/09/2015, ref: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F2

Study design

Parallel two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Anxiety

Intervention

The study enrolled 584 participants who have not participated in the first phase of this study (A cross-sectional study on associated factors of anxiety among primary school children in Jerantut, Pahang, Malaysia). Method for randomisation is simple randomisation method.

Participants in the intervention group were invited to participate in a 4-weeks school-based anxiety prevention program. The intervention program consists of 4 sessions, with each session implemented on each week.

The control group is a wait-list control group. After the participants in the intervention group completed all the sessions of the school-based anxiety prevention program, the participants in the control group were offered the same program thereafter.

Participants in both groups were followed-up immediately and at three months post intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Anxiety symptoms, measured using the sum score on the short version of Revised Child Anxiety and Depression Scale (RCADS-25) at baseline and follow-up assessments immediately and at three months post intervention

Secondary outcome measures

Worry coping skill and self-esteem, measured using the total score on the Children's Worry Management Scale (CWMS) and the Rosenberg Self-Esteem Scale (RSES) at baseline and follow-up assessments immediately and at three months post intervention

Overall trial start date

01/05/2016

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary school children who are attending selected primary schools in Jerantut, Pahang, Malaysia
2. Aged 10-11 years old

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

This study aimed for 12 clusters (mean of participants in each cluster is 55) (6 clusters for intervention and 6 clusters for control group)

Participant exclusion criteria

1. Cannot comprehend and write English and Malay language
2. Non Malaysian

Recruitment start date

06/02/2017

Recruitment end date

17/07/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

Government Primary School
Jerantut
Pahang
27000
Malaysia

Sponsor information

Organisation

University Putra Malaysia

Sponsor details

c/o Sherina Mohd Sidik
Cancer Resource & Education Centre (CaRE)
Universiti Putra Malaysia
UPM Serdang
Selangor
43400
Malaysia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Universiti Putra Malaysia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository. Type of data will be stored is the data gathered from the questionnaire, the process for requesting access is by obtaining permission through email, consent from participants was obtained and ethics approval was obtained from the Ethics Committee for Research involving Human Subjects of Universiti Putra Malaysia (JKEUPM) and Ministry of Education Malaysia.

Intention to publish date

31/07/2018

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes