Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

NCT02713425 | Completed Results

• 1 other identifier: 14-000162
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; Social Phobia; Separation Anxiety; Generalized Anxiety; GAD; Phobia; video game; teen; youth; child; adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Average Child Rating of Preferring the Game to Not Having the Game

  approximately 30 minutes

Study Arms (1)

Single Arm - Entertaining Video Game

EXPERIMENTAL

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.

Device: Entertaining Video Game

Interventions

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.

Single Arm - Entertaining Video Game

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social; Anxiety, Separation; Generalized Anxiety Disorder; Phobic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Results Point of Contact

• Title: Stephen P. Whiteside, PhD, LP
• Organization: Mayo Clinic

Whiteside.Stephen@mayo.edu

507-284-2933

Study Officials

• Stephen Whiteside, Ph.D., L.P.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: October 1, 2016
• Primary Completion: June 15, 2017
• Study Completion: July 15, 2017
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)