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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm - Entertaining Video Game | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entertaining Video Game | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Age 7 to 17
Primary diagnosis of:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Whiteside, Ph.D., L.P. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm - Entertaining Video Game | 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. Entertaining Video Game: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We had a total of 20 children complete the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm - Entertaining Video Game | 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. Entertaining Video Game: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | approximately 10 minutes |
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The patients were assessed over an approximately two to three hour period
Participants were monitored during the study for AE/SAE's. None of the patients experienced an AE or SAE. The parent and child has been combined due to the parent having to answer just a couple of questions at the end of the study where as the child participated in the whole study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm - Entertaining Video Game | 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. Entertaining Video Game: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen P. Whiteside, PhD, LP | Mayo Clinic | 507-284-2933 | Whiteside.Stephen@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2019 | Apr 15, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 4, 2016 | Apr 15, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000072861 | Phobia, Social |
| D001010 | Anxiety, Separation |
| D000098647 | Generalized Anxiety Disorder |
| D010698 | Phobic Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Average Child Rating of Preferring the Game to Not Having the Game | rating of 0(without) to 10 (with) preference to use game | children with anxiety piloting game | Posted | Mean | Standard Deviation | units on a scale | approximately 30 minutes |
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| 20 |
| 0 |
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| 20 |
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