AnxietyNCT02713425
Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
A study testing Entertaining Video Game in people with Anxiety, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Entertaining Video Game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 15 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- History of and/or current diagnosis of:
- psychosis,
- autism,
- bipolar disorder,
- mental retardation,
- oppositional defiant disorder,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Entertaining Video Game
- Keywords
- Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, video game, teen, youth, child, adolescent
- Medical subject headings
- Anxiety Disorders, Phobia, Social, Anxiety, Separation, Generalized Anxiety Disorder, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entertaining Video GameDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Entertaining Video Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 10 minutes
Secondary outcomes (1)
Average Child Rating of Preferring the Game to Not Having the Game
rating of 0(without) to 10 (with) preference to use game
Measured: approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start1 Oct 2016
- Primary completion15 Jun 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Whiteside, Mayo Clinic
- Investigators
- Stephen Whiteside, Ph.D., L.P., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713425
- Sponsor's protocol ID
- 14-000162
- Status last verified
- Aug 2019
- First submitted
- 15 Mar 2016
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
- ClinicalTrials.gov ID
- NCT02713425
- Acronym / sponsor ID
- 14-000162
- Conditions
- Anxiety
- Keywords
- Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, video game, teen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 4 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Entertaining Video Game | Experimental | Device: Entertaining Video GameThe 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 7 to 17
- Primary diagnosis of:
- A parent or other primary care giver available to participate with the child in all assessment and treatment activities
- Estimated average intelligence
- English speaking
Key exclusion criteria (12 listed)
- History of and/or current diagnosis of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entertaining Video GameChildren 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. | Device | Single Arm - Entertaining Video Game |
Primary outcome
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.
1 secondary outcome
Average Child Rating of Preferring the Game to Not Having the Game
Time frame: approximately 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Whiteside, Ph.D., L.P. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entertaining Video Game in people with Anxiety, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session (time frame: approximately 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.