- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03220581
A Psychotherapy Development Study for Internet Gaming
February 3, 2022 updated by: Kristyn Zajac, UConn Health
A Psychotherapy Development Study for a New Addictive Disorder
The fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) introduces Internet Gaming disorder (IGD) as a Substance-Related and Addictive Disorder in Section 3, Conditions for Further Study.
Although research is in the nascent stages, existing studies demonstrate that IGD is associated with psychosocial distress including suicidality, and adverse vocational and educational outcomes in youth.
Internet gaming disorder also shares substantial overlap with substance use, and it primarily affects adolescents, who rarely seek treatment on their own.
Parents more often express concerns about their child's game playing behaviors, and data suggest that parents can have strong influences on it.
This psychotherapy development study will evaluate feasibility, acceptability, and effect sizes of a behavioral intervention designed to help parents reduce gaming problems in their children.
Sixty concerned parents and their children will complete parental and self-report inventories and structured diagnostic interviews regarding the child's gaming behaviors, substance use and psychosocial functioning.
Participants will be randomized to either a control condition consisting of referral for mental health issues and family support services or to the same plus a 6-week family-based behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors and encouraging and rewarding alternatives to game playing.
Gaming and other problems will be assessed pre-treatment, mid-treatment, at the end of treatment, and at a 4-month follow-up.
This study is unique in evaluating initial psychometric properties of a parental version of a measure that uses the DSM-5 criteria for IGD in a clinical sample, and it will also assess associations of IGD with substance use, psychological symptoms, and family functioning over time.
Most importantly, this study will be the first randomized trial of an intervention designed to reduce gambling problems, and results are likely to guide future research and treatment efforts related to this condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- UConn Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- parent/guardian of a 10-19 year old residing in the same household >8 months/year
- reports significant problems with game playing
Exclusion Criteria:
- have a condition that may hinder study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Referral for care
Referral for mental health issues and family support services
|
referral for addictions support
|
|
Experimental: Behavioral therapy
8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors
|
referral for addictions support
therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Who Completed All 6 Sessions
Time Frame: 12 weeks
|
Completion of sessions is an indicator of treatment acceptability and feasibility
|
12 weeks
|
|
Number of Days of Gaming in Past Week - Reported by Child
Time Frame: 12 weeks
|
Number of days of game playing in past week is an indicator of severity of the gaming problem.
|
12 weeks
|
|
Number of Days of Gaming in the Past Week - Reported by Parent
Time Frame: 12 weeks
|
Number of days of gaming is an indicator of the severity of the gaming problem.
|
12 weeks
|
|
Number of Symptoms of Internet Gaming Disorder - Assessed Through a Clinical Interview With Child
Time Frame: 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.
|
12 weeks
|
|
Number of Symptoms of Internet Gaming Disorder - Assessed Through a Clinical Interview With Parent
Time Frame: 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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristyn Zajac, PhD, UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
July 14, 2017
First Submitted That Met QC Criteria
July 14, 2017
First Posted (Actual)
July 18, 2017
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
February 3, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-028-2
- R21DA042900 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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