Anxiety
Conditions
Keywords
Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, video game, teen, youth, child, adolescent
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.
Interventions
DEVICEEntertaining 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Arm - Entertaining Video Game |
|---|---|
| Age, Categorical <=18 years | 20 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: approximately 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Entertaining Video Game | Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session | 0.74 score on a scale | Standard Deviation 2.4 |
Secondary
Average Child Rating of Preferring the Game to Not Having the Game
rating of 0(without) to 10 (with) preference to use game
Time frame: approximately 30 minutes
Population: children with anxiety piloting game
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Entertaining Video Game | Average Child Rating of Preferring the Game to Not Having the Game | 6.22 units on a scale | Standard Deviation 2.6 |