|
Field
Trial Status
|
Before
completed
|
After
on_going
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|
Field
Trial Start Date
|
Before
March 03, 2025
|
After
January 25, 2026
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|
Field
Trial End Date
|
Before
May 26, 2025
|
After
September 30, 2026
|
|
Field
Last Published
|
Before
April 11, 2026 10:22 AM
|
After
April 11, 2026 11:03 AM
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|
Field
Intervention Start Date
|
Before
March 17, 2025
|
After
May 04, 2026
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|
Field
Intervention End Date
|
Before
May 26, 2025
|
After
June 30, 2026
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|
Field
Primary Outcomes (End Points)
|
Before
To check the effectiveness of Virtual-Reality Based Treatment to reduce aggression in children.
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After
To check the efficacy of Virtual-Reality Based Treatment to reduce aggression in children.
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|
Field
Primary Outcomes (Explanation)
|
Before
The outcome will be constructed by comparing the scores on the aggression scale at three-time points: baseline (before the intervention), immediately after the intervention, and during follow-up periods (e.g., 3 and 6 months post-intervention).
|
After
The outcome will be constructed by comparing the scores on the aggression scale at 2 points: baseline (before the intervention-baseline) and immediately after the intervention (Post-intervention)
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|
Field
Experimental Design (Public)
|
Before
Randomized Controlled Trial
|
After
Pilot Randomized Controlled Trial
|
|
Field
Was the treatment clustered?
|
Before
Yes
|
After
No
|
|
Field
Planned Number of Clusters
|
Before
3-4 schools
|
After
1 school
|
|
Field
Planned Number of Observations
|
Before
128 students
|
After
40 students
|
|
Field
Sample size (or number of clusters) by treatment arms
|
Before
3-4 schools both treatment
|
After
1 schools both treatment
|
|
Field
Intervention (Hidden)
|
Before
The intervention will consist of 8-10 sessions, each lasting 45 minutes, where children will engage with virtual reality-based scenarios. Initially, their aggression levels will be assessed using a questionnaire. Parents and teachers will also participate to provide additional insights about the child. The VR-based intervention is designed to be repetitive, allowing children to interact, communicate, and play with virtual peers in various situations, all under the therapist's guidance. In each session, a new skill will be introduced, and the child will practice applying it in situations that may arouse anger.
|
After
The intervention will consist of 8 sessions, once a week for an hour, where children will engage with a virtual reality-based Cognitive behavior therapy intervention. Initially, their aggression levels will be assessed using a questionnaire. Parents and teachers will also participate to provide additional insights about the child. The VR-based intervention is designed and adapted by allowing children to interact, communicate, and immerse themselves in a virtual environment, all under the therapist's guidance. In each session, a new skill will be introduced, and the child will practice applying it in situations in real life to reduce anger.
|
|
Field
Did you obtain IRB approval for this study?
|
Before
No
|
After
Yes
|
|
Field
Secondary Outcomes (Explanation)
|
Before
this outcome will assess how effectively children acquire and apply new skills in anger-arousing situations, as practised in the VR sessions. Observations and feedback from therapists, parents, and teachers will be used to measure this.
|
After
This outcome will assess how effectively children acquire and apply new skills in anger-arousing situations, as practised in the VR sessions. Observations and feedback from therapists, parents, and teachers will be used to measure this.
|