World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 29 August 2022
Main ID:  ISRCTN10083640
Date of registration: 24/05/2018
Prospective Registration: No
Primary sponsor: University Putra Malaysia
Public title: A school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia
Scientific title: A randomized controlled trial on a school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia
Date of first enrolment: 06/02/2017
Target sample size: 660
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN10083640
Study type:  Interventional
Study design:  Parallel two-arm randomized controlled trial (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Malaysia
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Sherina    Mohd Sidik
Address:  Cancer Resource & Education Centre (CaRE) Universiti Putra Malaysia 43400 Selangor Malaysia
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
Current inclusion criteria as of 16/01/2019:
1. Primary school children who are attending selected primary schools in Jerantut, Pahang, Malaysia
2. Standard 4 and 5 primary school children

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

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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Anxiety
Mental and Behavioural Disorders
Anxiety disorder, unspecified
Intervention(s)

Current interventions as of 16/01/2019:
The study enrolled twelve primary schools which have not participated in the first phase of this study (An analytical 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.

Previous interventions:
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 there
Primary Outcome(s)
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(s)
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
Secondary ID(s)
N/A
Source(s) of Monetary Support
Universiti Putra Malaysia
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
University Putra Malaysia, 04/09/2015, ref: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F2
Results
Results available: Yes
Date Posted:
Date Completed: 31/12/2017
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history