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

Last registered on August 01, 2022

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
August 01, 2022, 2:04 AM EDT

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

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Primary Investigator

Affiliation
Foundation University Islamabad

Other Primary Investigator(s)

PI Affiliation
Foundation University Islamabad
PI Affiliation
Foundation University Islamabad

Additional Trial Information

Status
In development
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 aims to evaluate the acceptability and feasibility of delivering the cognitive-behavioral therapy-based intervention in a Pakistani school setting. The present study is a single-blind, two arms, feasibility randomized controlled trial which will be conducted in Urban schools of Rawalpindi. A sample of 24, secondary school children, aged 14 -18 years, will be approached from 4 private schools located in Rawalpindi. Initial screening will be carried out and then participants are going to be randomized into the intervention arm and control arm. Participants in the intervention arm will receive cognitive-behavioral therapy. A total of 8 group therapy sessions, each lasting for at least 50-60 minutes will be given. While participants in the control arm will receive no such treatment. The feasibility investigation demonstrates a lower level of anxiety among participants and the acceptability of the design. Results of this feasibility randomized control trial will further be beneficial in the capacity building of teachers who can further identify the risk factors of anxiety and be able to take precautionary measures on time.
External Link(s)

Registration Citation

Citation
Ijaz, Saman, Shahid Irfan and Iffat Rohail. 2022. "Feasibility Evaluation of Intervention for Anxiety using CBT among Secondary School Children in Pakistan: A randomized Controlled Trial ." AEA RCT Registry. August 01. https://doi.org/10.1257/rct.9551
Experimental Details

Interventions

Intervention(s)
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)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Pre-post and follow up/baseline designstratified
Experimental Design Details
Not available
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
24 students
Sample size (or number of clusters) by treatment arms
12 control, 12 treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number