Back to resultsPediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Entertaining Video Game
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, video game, teen, youth, child, adolescent
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm - Entertaining Video Game
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Average Child Rating of Preferring the Game to Not Having the Game
rating of 0(without) to 10 (with) preference to use game
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02713425
Brief Title
Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
Official Title
Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, video game, teen, youth, child, adolescent
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm - Entertaining Video Game
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Entertaining Video Game
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session
Description
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.
Time Frame
approximately 10 minutes
Secondary Outcome Measure Information:
Title
Average Child Rating of Preferring the Game to Not Having the Game
Description
rating of 0(without) to 10 (with) preference to use game
Time Frame
approximately 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Whiteside, Ph.D., L.P.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
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