Trial Outcomes & Findings for A Psychotherapy Development Study for Internet Gaming (NCT NCT03220581)

NCT ID: NCT03220581

Last Updated: 2022-02-07

Results Overview

Completion of sessions is an indicator of treatment acceptability and feasibility

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-02-07

Participant Flow

Children were required to participate with a parent; therefore, all children had a parent enrolled in the study. A total of 60 dyads were enrolled in the study. The participant flow table represents the number of children enrolled in the study, as they were the primary target of the intervention.

Participant milestones

Participant milestones
Measure	Referral for Care Referral for mental health issues and family support services Referral for care: referral for addictions support	Behavioral Therapy 8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Overall Study STARTED	28	32
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Referral for Care Referral for mental health issues and family support services Referral for care: referral for addictions support	Behavioral Therapy 8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	3	6

Baseline Characteristics

A Psychotherapy Development Study for Internet Gaming

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Referral for Care n=28 Participants Referral for mental health issues and family support services Referral for care: referral for addictions support	Behavioral Therapy n=32 Participants 8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	13.18 years STANDARD_DEVIATION 2.29 • n=5 Participants	13.84 years STANDARD_DEVIATION 2.20 • n=7 Participants	13.53 years STANDARD_DEVIATION 2.25 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	27 Participants n=7 Participants	48 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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	32 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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

Outcome measures
Measure	Behavioral Therapy n=32 Participants 6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills	Behavioral Therapy 6 session behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Percentage of Participants Who Completed All 6 Sessions	40.6 percentage of participants	—

PRIMARY outcome

Timeframe: 12 weeks

Number of days of game playing in past week is an indicator of severity of the gaming problem.

Outcome measures

Outcome measures
Measure	Behavioral Therapy n=25 Participants 6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills	Behavioral Therapy n=25 Participants 6 session behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Number of Days of Gaming in Past Week - Reported by Child	5.04 days/week Standard Deviation 1.81	3.24 days/week Standard Deviation 2.28

PRIMARY outcome

Timeframe: 12 weeks

Population: The participants included in these analyses were all participants who completed the post-treatment (12 week) assessment. This number differs from the Participant Flow module, which reports the number of participants who completed the final follow-up at 24 weeks.

Number of days of gaming is an indicator of the severity of the gaming problem.

Outcome measures

Outcome measures
Measure	Behavioral Therapy n=26 Participants 6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills	Behavioral Therapy n=25 Participants 6 session behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Number of Days of Gaming in the Past Week - Reported by Parent	6.19 days/week Standard Deviation 1.58	4.04 days/week Standard Deviation 3.02

PRIMARY outcome

Timeframe: 12 weeks

Examines whether the treatment group showed greater reductions in symptoms of Internet gaming disorder than the control group. Ratings of Internet gaming disorder symptoms were assessed using a clinical interview with the child, conducted by trained assessors blind to treatment condition.

Outcome measures

Outcome measures
Measure	Behavioral Therapy n=25 Participants 6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills	Behavioral Therapy n=26 Participants 6 session behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Number of Symptoms of Internet Gaming Disorder - Assessed Through a Clinical Interview With Child	1.28 Symptoms at post-treatment Standard Deviation 1.34	0.65 Symptoms at post-treatment Standard Deviation 1.09

PRIMARY outcome

Timeframe: 12 weeks

Examines whether the treatment group showed greater reductions in symptoms of Internet gaming disorder than the control group. Ratings of Internet gaming disorder symptoms were assessed using a clinical interview with the parent, conducted by trained assessors blind to treatment condition.

Outcome measures

Outcome measures
Measure	Behavioral Therapy n=26 Participants 6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills	Behavioral Therapy n=25 Participants 6 session behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Number of Symptoms of Internet Gaming Disorder - Assessed Through a Clinical Interview With Parent	2.81 Symptoms at post-treatment Standard Deviation 1.81	1.84 Symptoms at post-treatment Standard Deviation 1.65

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: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Referral for Care n=28 participants at risk Referral for mental health issues and family support services Referral for care: referral for addictions support	Behavioral Therapy n=32 participants at risk 8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Referral for care: referral for addictions support Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
Injury, poisoning and procedural complications Inpatient Hospitalization	3.6% 1/28 • Number of events 1 • From baseline to 24 week follow-up	0.00% 0/32 • From baseline to 24 week follow-up

Other adverse events

Adverse event data not reported

Additional Information

Kristyn Zajac, PhD

UConn Health

Phone: 860-679-8572

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place