N/A
N=20
Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02713425 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session — 0.74 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Entertaining Video Game (Device)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session |
0.74 | — |
| SECONDARY Average Child Rating of Preferring the Game to Not Having the Game |
6.22 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02713425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.