Back to History

Fields Changed

Registration

Field Before After
Trial Status in_development completed
Last Published November 14, 2022 01:58 AM March 01, 2023 01:58 AM
Study Withdrawn No
Intervention Completion Date October 17, 2022
Data Collection Complete Yes
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
Is there a restricted access data set available on request? Yes
Restricted Data Contact [email protected]
Program Files No
Data Collection Completion Date October 22, 2022
Is data available for public use? No
Intervention (Public) Cognitive Behavior therapy for management of Self regulation issues like aggression etc 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.
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
Experimental Design (Public) Experimental Design Pre-post and follow up/baseline designs stratified Mixed Design Experimental Design
Planned Number of Observations 24 students 23 students
Sample size (or number of clusters) by treatment arms 12 treatment arm 12 control 12 treatment arm 11 control
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
Did you obtain IRB approval for this study? No Yes
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.
Back to top

Irbs

Field Before After
IRB Name Foundation University Review Board
IRB Approval Number n/a
Back to top