A school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia
| ISRCTN | ISRCTN10083640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10083640 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/12/2017
- Registration date
- 24/05/2018
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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?
Standard 4 and 5 children 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
Contact information
Scientific
Cancer Resource & Education Centre (CaRE)
Universiti Putra Malaysia
Selangor
43400
Malaysia
Study information
| Study design | Parallel two-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomized controlled trial on a school-based anxiety prevention program for primary school children in Jerantut, Pahang, Malaysia |
| Study objectives | 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(s) | University Putra Malaysia, 04/09/2015, ref: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F2 |
| Health condition(s) or problem(s) studied | Anxiety |
| Intervention | 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 thereafter. Participants in both groups were followed-up immediately and at three months post intervention. |
| Intervention type | Behavioural |
| 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 study start date | 01/05/2016 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Sex | 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) |
| Key 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 |
| Key exclusion criteria | 1. Cannot comprehend and write English and Malay language 2. Non Malaysian |
| Date of first enrolment | 06/02/2017 |
| Date of final enrolment | 17/07/2017 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Pahang
27000
Malaysia
Sponsor information
University/education
c/o Sherina Mohd Sidik
Cancer Resource & Education Centre (CaRE)
Universiti Putra Malaysia
UPM Serdang
Selangor
43400
Malaysia
"ROR" |
https://ror.org/02e91jd64 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/01/2019 | 16/01/2019 | No | No | |
| Results article | 05/12/2019 | 16/08/2022 | Yes | No |
Additional files
- ISRCTN10083640_BasicResults_16Jan19.pdf
- Uploaded 16/01/2019
Editorial Notes
16/08/2022: Publication reference added.
23/01/2019: The intention to publish date has been changed from 31/07/2018 to 31/12/2019
16/01/2019: The following changes have been made to the trial record:
1. The interventions have been changed
2. Participant inclusion criteria have been changed
3. The plain English summary has been changed to reflect the changes above
4. The basic results of this trial have been uploaded as an additional file
