Main
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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:
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ISRCTN |
Last refreshed on:
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29 August 2022 |
Main ID: |
ISRCTN10083640 |
Date of registration:
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24/05/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia
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Scientific title:
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A randomized controlled trial on a school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia |
Date of first enrolment:
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06/02/2017 |
Target sample size:
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660 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN10083640 |
Study type:
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Interventional |
Study design:
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Parallel two-arm randomized controlled trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Sherina
Mohd Sidik |
Address:
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Cancer Resource & Education Centre (CaRE)
Universiti Putra Malaysia
43400
Selangor
Malaysia |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Anxiety Mental and Behavioural Disorders Anxiety disorder, unspecified
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Universiti Putra Malaysia
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Ethics review
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Status:
Approval date:
Contact:
University Putra Malaysia, 04/09/2015, ref: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F2
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/12/2017 |
URL:
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