Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

Anxiety Clinical Trial

Official title:

Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713425
• Other study ID #: 14-000162
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: July 15, 2017

Study information

• Verified date: August 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	approximately 10 minutes
Secondary	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