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

Last registered on March 01, 2023

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
March 01, 2023, 1:59 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

Additional Trial Information

Status
Completed
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. 2023. "FEASIBILITY EVALUATION OF INTERVENTION FOR SELF REGULATION USING CBT AMONG SECONDARY SCHOOL CHILDREN IN PAKISTAN: A RANDOMIZED CONTROLLED TRIAL." AEA RCT Registry. March 01. https://doi.org/10.1257/rct.9754-4.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
CBT based intervention is used in present study to enhance self-regulation among school children. This intervention aimed to alter faulty cognitions that can become the root cause of behavioral and emotional problems in later stages.
Intervention (Hidden)
This CBT based intervention includes strategies that help students in following areas:
1. Leading and Living with Integrity
2. Being Open to Change
3. Identifying Your Triggers
4. Practicing Self-Discipline
5. Reframing Negative Thoughts
6. Keeping Calm Under Pressure
7. Considering the Consequences
8. Believing in Yourself

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)
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 improvement of self-regulation in secondary school children

Secondary Outcomes

Secondary Outcomes (end points)
self regulation training program will also help in reduction in other behavioral and emotional risk problems.
Secondary Outcomes (explanation)
Children will lean to manage their emotions and behaviors in social contexts.

Experimental Design

Experimental Design
Mixed Design
Experimental Design
Experimental Design Details
This study was a randomized controlled trial with a parallel group design that compared the effects of Self-Regulation CBT Intervention along with a controlled group. After baseline assessment using BASC III, participants were randomly assigned to Self-Regulation CBT Intervention Trial. Successively, Intervention for Self-Regulation using CBT was provided in 8 sessions.

The participants of the current study included Secondary School Children (SSC), (8th, 9th & 10th grades students) from various campuses of Fauji Foundation Schools, Islamabad. The sample for the current trial of Self-Regulation Intervention included a total of 23 students. However, the Control Group comprised of n=11 students and in Experimental Group n=12. Age of the students yielded from 13 to 16 years old.
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
23 students
Sample size (or number of clusters) by treatment arms
12 treatment arm
11 control
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
n/a

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
October 22, 2022, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
4 schools.
23 students. A total of 23 students were selected for final trial.
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
23
Final Sample Size (or Number of Clusters) by Treatment Arms
12 in experimental group and 11 in control group
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