Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

Study Overview
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Brief Summary
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This research study aims to test the feasibility and effectiveness of using an entertaining video game as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.

Detailed Description
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The purpose of this research is to learn whether or not youth with social anxiety find a therapeutic video game engaging and useful. Children between the ages of 7 & 17 who have been diagnosed with a social anxiety disorder will be invited to participate in this study.

Official Title
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Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

Conditions
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Anxiety

Intervention / Treatment
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* Device: Entertaining Video Game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 7 to 17 Primary diagnosis of: social phobia, separation anxiety disorder A parent or other primary care giver available to participate with the child in all assessment and treatment activities Estimated average intelligence English speaking Received les than 3 treatment sessions for social anxiety disorder Exclusion Criteria: History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism, or major depressive disorder Current suicidality or recent suicidal behavior Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties Starting or changing the dosage of a psychiatric medication in the last two months

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm - Entertaining Video Game<br>The children in this study will have a single visit. During this visit they will be introduced to the game. The child will then interact with the game and after they have finished, they will be asked questions about their experience with the game. Parents will observe and provide their own feedback about the game. | Device: Entertaining Video Game<br>* Children between 7 & 17 with a social anxiety disorder will be invited to participate in this study. They will attend a single visit. During the visit they will use the therapeutic game. They will be monitored while using the game. After the completion, they will be asked questions regarding their experience with this therapeutic game.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session | Subjective Units of Distress Scale (SUDs) - of 0 to 10 ratings, where 0 indicates that they feel no anxiety whatsoever and 10 indicates that they are experiencing maximum distress. The child interacts with the game for up to 30 minutes. The interviewer observes and records the child's interaction with the game. The child then has an opportunity to perform a real life exposure. For the remainder of the time, the interviewer will interview the child about his/her experience with the game. They will also get feedback from the parent. | approximately 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Child Rating of Preferring the Game to Not Having the Game | rating of 0(without) to 10 (with) preference to use game | approximately 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GAD, Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, Phobia, video game, teen, youth, child, adolescent