Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02713425
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Device: Entertaining Video Game	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Jun 15, 2017
• Actual Study Completion Date: Jul 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm - 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 7 to 17

2. Primary diagnosis of:

3. social phobia,

4. separation anxiety disorder

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

6. Estimated average intelligence

7. English speaking

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

Exclusion Criteria:

1. History of and/or current diagnosis of:

2. psychosis,

3. autism,

4. bipolar disorder,

5. mental retardation,

6. oppositional defiant disorder,

7. PTSD,

8. selective mutism, or

9. major depressive disorder

10. Current suicidality or recent suicidal behavior

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Stephen Whiteside, Ph.D., L.P., Mayo Clinic

Study Documents (Full-Text)

• Statistical Analysis Plan - Mar 14, 2019
• Study Protocol - Oct 4, 2016

More Information

Publications

None provided.

• Responsible Party: Stephen Whiteside, Associate Professor of Psychology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02713425
• Other Study ID Numbers: 14-000162
• First Posted: Mar 18, 2016
• Last Update Posted: Sep 4, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Stephen Whiteside, Associate Professor of Psychology, Mayo Clinic: Anxiety; Social Phobia; Separation Anxiety; Generalized Anxiety; GAD; Phobia; video game; teen; youth; child; adolescent
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	Single Arm - Entertaining Video Game
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Single Arm - Entertaining Video Game
Arm/Group Description	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. 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.
Overall Participants	20
Age (Count of Participants)
<=18 years	20 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	11 55%
Male	9 45%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	19 95%
More than one race	0 0%
Unknown or Not Reported	1 5%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session
Description	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.
Time Frame	approximately 10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm - Entertaining Video Game
Arm/Group Description	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. 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.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	0.74 (2.4)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

children with anxiety piloting game

Arm/Group Title	Single Arm - Entertaining Video Game
Arm/Group Description	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. 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.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	6.22 (2.6)

Adverse Events

Time Frame	The patients were assessed over an approximately two to three hour period
Adverse Event Reporting Description	Participants were monitored during the study for AE/SAE's. None of the patients experienced an AE or SAE. The parent and child has been combined due to the parent having to answer just a couple of questions at the end of the study where as the child participated in the whole study.
Arm/Group Title	Single Arm - Entertaining Video Game
Arm/Group Description	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. 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.
All Cause Mortality
	Single Arm - Entertaining Video Game
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Single Arm - Entertaining Video Game
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm - Entertaining Video Game
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.