FEASIBILITY EVALUATION OF INTERVENTION FOR SELF REGULATION USING CBT AMONG SECONDARY SCHOOL CHILDREN IN PAKISTAN: A RANDOMIZED CONTROLLED TRIAL

Last registered on November 14, 2022

Pre-Trial

Trial Information

General Information

Title
FEASIBILITY EVALUATION OF INTERVENTION FOR SELF REGULATION USING CBT AMONG SECONDARY SCHOOL CHILDREN IN PAKISTAN: A RANDOMIZED CONTROLLED TRIAL
RCT ID
AEARCTR-0009754
Initial registration date
July 15, 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
July 21, 2022, 11:30 AM EDT

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

Last updated
November 14, 2022, 1:58 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

Additional Trial Information

Status
In development
Start date
2022-08-15
End date
2022-12-12
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Self-regulation plays an important role in adolescent development, predicting success in multiple domains including school and social relationships. Adolescents with better self-regulatory abilities are also less likely to engage in transgressive behaviors and more likely to engage in prosocial behaviors. Aggressive behavior expressed by adolescents is a worrying phenomenon. There might be circumstances underlying this aggression, such as adaptive or maladaptive emotional conditions. This requires the critical need for indigenous, evidence-based intervention to address the stated problem of adolescents and provide the intervention in the future. Thus, this clinical trial provides an intervention plan using cognitive behavior therapy techniques for the self-regulation and emotion regulation. 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 self control 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 self control issues and be able to take precautionary measures on time.
External Link(s)

Registration Citation

Citation
Rohail, Iffat et al. 2022. "FEASIBILITY EVALUATION OF INTERVENTION FOR SELF REGULATION USING CBT AMONG SECONDARY SCHOOL CHILDREN IN PAKISTAN: A RANDOMIZED CONTROLLED TRIAL." AEA RCT Registry. November 14. https://doi.org/10.1257/rct.9754-2.0
Experimental Details

Interventions

Intervention(s)
Cognitive Behavior therapy for management of Self regulation issues like aggression etc
Intervention Start Date
2022-08-22
Intervention End Date
2022-10-17

Primary Outcomes

Primary Outcomes (end points)
The primary outcome of this trial will be to develop insight and management of the self and emotion regulation in children who are at risk.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Experimental Design
Pre-post and follow up/baseline designs stratified
Experimental Design Details
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 schools
Sample size: planned number of observations
24 students
Sample size (or number of clusters) by treatment arms
12 treatment arm
12 control
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

Post-Trial

Post Trial Information

Study Withdrawal

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials