Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Device: Entertaining Video Game

• Registration Number: NCT02713425
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-18
• Study Start: 2016-10-01
• Primary Completion: 2017-06-15
• Study Completion: 2017-07-15
• Results First Submitted: 2019-03-14
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Results First Posted: 2019-09-04
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 7 to 17

2. Primary diagnosis of:

   1. social phobia,
   2. separation anxiety disorder

3. A parent or other primary care giver available to participate with the child in all assessment and treatment activities

4. Estimated average intelligence

5. English speaking

6. Received les than 3 treatment sessions for social anxiety disorder

Exclusion Criteria

1. History of and/or current diagnosis of:

   1. psychosis,
   2. autism,
   3. bipolar disorder,
   4. mental retardation,
   5. oppositional defiant disorder,
   6. PTSD,
   7. selective mutism, or
   8. major depressive disorder

2. Current suicidality or recent suicidal behavior

3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties

4. Starting or changing the dosage of a psychiatric medication in the last two months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm - Entertaining Video Game	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.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session	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 Outcome Measures

Name	Time	Method
Average Child Rating of Preferring the Game to Not Having the Game	approximately 30 minutes	rating of 0(without) to 10 (with) preference to use game

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States