Internet Gaming DisorderNCT03220581
A Psychotherapy Development Study for Internet Gaming
A study testing Referral for care and Behavioral therapy in people with Internet Gaming Disorder, run by UConn Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- Referral for care and Behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- parent/guardian of a 10-19 year old residing in the same household >8 months/year
- reports significant problems with game playing
Who cannot join
- have a condition that may hinder study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Internet Gaming Disorder
- Being tested
- Referral for care, Behavioral therapy
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral for careBehavioural
referral for addictions support
Behavioral therapyBehavioural
therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
| Study group | Role | What they receive |
|---|---|---|
| Referral for care | Active comparator | Referral for mental health issues and family support services Receives: Behavioral: Referral for care |
| Behavioral therapy | Experimental | 8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors Receives: Behavioral: Referral for care; Behavioral: Behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Completed All 6 Sessions
Completion of sessions is an indicator of treatment acceptability and feasibility
Measured: 12 weeks
Number of Days of Gaming in Past Week - Reported by Child
Number of days of game playing in past week is an indicator of severity of the gaming problem.
Measured: 12 weeks
Number of Days of Gaming in the Past Week - Reported by Parent
Number of days of gaming is an indicator of the severity of the gaming problem.
Measured: 12 weeks
Number of Symptoms of Internet Gaming Disorder - Assessed Through a Clinical Interview With Child
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.
Measured: 12 weeks
Number of Symptoms of Internet Gaming Disorder - Assessed Through a Clinical Interview With Parent
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Oct 2017
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Internet Gaming DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kristyn Zajac, UConn Health
- Investigators
- Kristyn Zajac, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220581
- Sponsor's protocol ID
- 17-028-2
- Other IDs
- R21DA042900
- Status last verified
- Feb 2022
- First submitted
- 14 Jul 2017
- Last updated
- 7 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychotherapy Development Study for a New Addictive Disorder
- ClinicalTrials.gov ID
- NCT03220581
- Acronym / sponsor ID
- 17-028-2
- Conditions
- Internet Gaming Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral for care | Active comparator | Behavioral: Referral for careReferral for mental health issues and family support services |
| Behavioral therapy | Experimental | Behavioral: Referral for care, Behavioral: Behavioral therapy8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- parent/guardian of a 10-19 year old residing in the same household >8 months/year
- reports significant problems with game playing
Key exclusion criteria (1 listed)
- have a condition that may hinder study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral for carereferral for addictions support | Behavioural | Behavioral therapy, Referral for care |
| Behavioral therapytherapy focused on monitoring gaming behavior and replacing it with other activities and communication skills | Behavioural | Behavioral therapy |
Primary outcome
Percentage of Participants Who Completed All 6 Sessions
Time frame: 12 weeks
Completion of sessions is an indicator of treatment acceptability and feasibility
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristyn Zajac, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral for care and Behavioral therapy in people with Internet Gaming Disorder, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Completed All 6 Sessions (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022; AzTrials last refreshed its copy on 27 Oct 2026.