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OpenTrials
Completed

NCT Number: NCT02713425

Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

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.

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Key information

Conditions

Anxiety Anxiety Disorders Anxiety, Separation Generalized Anxiety Disorder Mental Disorders Neurodevelopmental Disorders Phobia, Social Phobic Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entertaining Video Game

Device

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 outcomes

  1. 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

  1. Average Child Rating of Preferring the Game to Not Having the Game

    Time frame: approximately 30 minutes

    rating of 0(without) to 10 (with) preference to use game

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2016
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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