Feasibility Evaluation of Intervention for Anxiety using CBT among Secondary School Children in Pakistan: A randomized Controlled Trial

Last registered on February 28, 2023

Pre-Trial

Trial Information

General Information

Title
Feasibility Evaluation of Intervention for Anxiety using CBT among Secondary School Children in Pakistan: A randomized Controlled Trial
RCT ID
AEARCTR-0009551
Initial registration date
June 18, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
June 21, 2022, 10:57 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
February 28, 2023, 3:47 AM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
Foundation University Islamabad

Other Primary Investigator(s)

PI Affiliation
Foundation University Islamabad
PI Affiliation
Foundation University Islamabad
PI Affiliation
Air University Islamabad
PI Affiliation
Foundation University Islamabad
PI Affiliation
Foundation University Islamabad

Additional Trial Information

Status
Completed
Start date
2022-07-04
End date
2022-11-15
Secondary IDs
HEC
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Anxiety is highly prevalent among adolescents, which can lead to serious problems in adulthood if left untreated. The global prevalence of anxiety disorders among children and adolescents is found to be 6.5%. As per the National Institutes of Health, over one-third of all adolescents between the ages of 13 and 18 will suffer from anxiety. Despite the existence of various treatments, this goes unrecognized and untreated. This highlights the critical need for indigenous, evidence-based intervention to promptly address these risk factors. Thus, the present study aimed to evaluate the acceptability and feasibility of delivering the cognitive-behavioral therapy-based intervention in a Pakistani school setting. The present study was a single-blind, two arms, feasibility randomized controlled trial which was be conducted in Urban schools of Rawalpindi. A total sample of 34 secondary school children (17 in each arm) with elevated scores of anxiety upon assessment from the four participating schools were included in the study. Randomization was done by an independent researcher. Since it was feasibility research, so no power calculations were performed, but it was ensured that the sample would be sufficient to predict the acceptance, uptake of the intervention, recruitment, and retention rates of participants for a future definitive trial. Primarily, the experimental group received therapy that comprised eight sessions and each session lasting for up to fifty minutes. Results were found to be significant with a reduction in the level of anxiety at post assessment (╬Ěp2= .32) as well as in follow-up when compared to baseline assessment. The intervention had a positive influence on young people, with the primary result being a reduction in anxiety, and the secondary outcomes being increased self-regulation and personal adjustment. Moreover, at the end of the trial, the willing participants of the wait-list control group were also accommodated for therapy. Results of this feasibility randomized control trial will further be beneficial in the capacity building of teachers who can identify the risk factors of anxiety and be able to take precautionary measures in time.
External Link(s)

Registration Citation

Citation
Rohail, Iffat et al. 2023. "Feasibility Evaluation of Intervention for Anxiety using CBT among Secondary School Children in Pakistan: A randomized Controlled Trial ." AEA RCT Registry. February 28. https://doi.org/10.1257/rct.9551-4.1
Sponsors & Partners

Sponsors

Experimental Details

Interventions

Intervention(s)
CBT based intervention is used in present study to reduce anxiety among school children. This intervention aimed to alter faulty cognitions that can become the root cause of anxiety in later stages. This intervention includes strategies that help students in following areas:
1. Restructuring faulty cognitions
2. Relaxation techniques
3. Exposure based techniques
4. Self-assessment and management
5. How to prevent relapse.
Intervention Start Date
2022-08-15
Intervention End Date
2022-10-31

Primary Outcomes

Primary Outcomes (end points)
levels of anxiety should decrease when the CBT Techniques will be applied to students for eight weeks
Primary Outcomes (explanation)
Cognitive behavior therapy is a pertinent therapy for many emotional problems and this trial is meant to see the feasibility of combination of CBT techniques for the reduction of anxiety in secondary school children

Secondary Outcomes

Secondary Outcomes (end points)
CBT based therapy will also help in improving other emotional behavioral problems as well.
Secondary Outcomes (explanation)
children will learn to channelize their emotions in a healthier and positive way.

Experimental Design

Experimental Design
Pre-post and follow up/baseline design
stratified
Experimental Design Details
A two arm parallel group, single blind randomized control trial was done. Stratified Random design was used for that purpose. Four schools were selected from Rawalpindi district and screening of a 651 students were done using BASC-BESS 3. Students with elevated scores of anxiety upon assessment included in the study after were screening and informed consent was obtained. 34 students were available for recruitment in treatment and control group. Simple random sampling was used to allocate students in two arms. 17 students were allocated in treatment and 17 were allocated in control group
Randomization Method
stratified random design
Randomization Unit
student, group level randomization for treatment
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
4
Sample size: planned number of observations
34 students
Sample size (or number of clusters) by treatment arms
17 control, 17 treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Foundation University Review Board
IRB Approval Date
Details not available
IRB Approval Number
Details not available

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
October 17, 2022, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
August 15, 2022, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
4 schools.
A total of 34 students were selected for final trial.
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
4 schools and 34 students in total.
Final Sample Size (or Number of Clusters) by Treatment Arms
17 in experimental arm and 17 in control arm.
Data Publication

Data Publication

Is public data available?
No

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Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials