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Clinical Trials/NCT02713425
NCT02713425
Completed
Not Applicable

Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

Mayo Clinic1 site in 1 country20 target enrollmentOctober 1, 2016
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Mayo Clinic
Enrollment
20
Locations
1
Primary Endpoint
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
July 15, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Whiteside

Associate Professor of Psychology

Mayo Clinic

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:
  • 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

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)

Study Sites (1)

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