Trial Outcomes & Findings for Reducing Internet Gaming (NCT NCT02726880)
NCT ID: NCT02726880
Last Updated: 2022-01-28
Results Overview
Completion of sessions is an indicator of treatment acceptability and feasibility
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-01-28
Participant Flow
Participant milestones
| Measure |
Referral for Care
Referral for care: Referral for mental health issues and family support services
|
Behavioral Therapy
Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Referral for Care
Referral for care: Referral for mental health issues and family support services
|
Behavioral Therapy
Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Reducing Internet Gaming
Baseline characteristics by cohort
| Measure |
Referral for Care
n=17 Participants
Referral for care: Referral for mental health issues and family support services
|
Behavioral Therapy
n=19 Participants
Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.06 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
50.58 years
STANDARD_DEVIATION 6.05 • n=7 Participants
|
47.97 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Number of days of gaming in the past week - reported by parent
|
6.41 days
STANDARD_DEVIATION 1.73 • n=5 Participants
|
6.42 days
STANDARD_DEVIATION 1.73 • n=7 Participants
|
6.42 days
STANDARD_DEVIATION 1.46 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This outcome is only reported for the Behavioral Therapy group because it is not relevant to the Referral to Care group. The Referral to Care group was not assigned to a structured 6 session intervention; thus, this outcome could not be measured in that group.
Completion of sessions is an indicator of treatment acceptability and feasibility
Outcome measures
| Measure |
Behavioral Therapy
n=19 Participants
6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors
|
Behavioral Therapy
Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
|
|---|---|---|
|
Percentage of Participants Who Complete All 6 Sessions
|
78.9 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The sample size for this analysis is smaller than the overall sample because several participants were lost to follow up.
Number of days of gaming is an indicator of the severity of the gaming problem.
Outcome measures
| Measure |
Behavioral Therapy
n=14 Participants
6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors
|
Behavioral Therapy
n=18 Participants
Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
|
|---|---|---|
|
Number of Days of Gaming in the Past Week - Reported by Parent
|
5.79 days
Standard Deviation 2.19
|
5.06 days
Standard Deviation 2.34
|
Adverse Events
Referral for Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Referral for Care
n=17 participants at risk
Referral for care: Referral for mental health issues and family support services
|
Behavioral Therapy
n=19 participants at risk
Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
|
|---|---|---|
|
Surgical and medical procedures
hernia operation
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
Other adverse events
| Measure |
Referral for Care
n=17 participants at risk
Referral for care: Referral for mental health issues and family support services
|
Behavioral Therapy
n=19 participants at risk
Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
|
|---|---|---|
|
Injury, poisoning and procedural complications
ER visit for car accident
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place