Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •bipolar disorder,
- •mental retardation,
- •oppositional defiant disorder,
- •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
Arms & Interventions
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. Parents will observe and provide their own feedback about the game.
Intervention: Entertaining Video Game (Device)
Outcomes
Primary Outcomes
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session
Time Frame: approximately 10 minutes
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 Outcomes
- Average Child Rating of Preferring the Game to Not Having the Game(approximately 30 minutes)
Investigators
Stephen Whiteside
Associate Professor of Psychology
Mayo Clinic