Trial Outcomes & Findings for Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study (NCT NCT02713425)

Last Updated: 2019-09-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

approximately 10 minutes

Results posted on

2019-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm - Entertaining Video Game n=20 Participants 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.
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 10 minutes

Outcome measures

Outcome measures
Measure	Single Arm - Entertaining Video Game n=20 Participants 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.
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 outcome

Timeframe: approximately 30 minutes

Population: children with anxiety piloting game

rating of 0(without) to 10 (with) preference to use game

Outcome measures

Outcome measures
Measure	Single Arm - Entertaining Video Game n=20 Participants 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.
Average Child Rating of Preferring the Game to Not Having the Game	6.22 units on a scale Standard Deviation 2.6

Adverse Events

Single Arm - Entertaining Video Game

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen P. Whiteside, PhD, LP

Mayo Clinic

Phone: 507-284-2933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place