Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21DA042900 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referral for care | Active Comparator | Referral for mental health issues and family support services |
|
| Behavioral therapy | Experimental | 8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Referral for care | Behavioral | referral for addictions support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Completed All 6 Sessions | Completion of sessions is an indicator of treatment acceptability and feasibility | 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. | 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. | 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. | 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. | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristyn Zajac, PhD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Referral for Care | Referral for mental health issues and family support services Referral for care: referral for addictions support |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Referral for Care | Referral for mental health issues and family support services Referral for care: referral for addictions support |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Completed All 6 Sessions | Completion of sessions is an indicator of treatment acceptability and feasibility | 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. | Posted | Number | percentage of participants | 12 weeks |
|
From baseline to 24 week follow-up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Referral for Care | Referral for mental health issues and family support services Referral for care: referral for addictions support |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
Not provided
There were no major limitations of the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristyn Zajac, PhD | UConn Health | 860-679-8572 | zajac@uchc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2020 | Jun 22, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2019 | Jun 23, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000082424 | Internet Addiction Disorder |
| ID | Term |
|---|---|
| D000088942 | Technology Addiction |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D011613 | Psychotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral therapy | Behavioral | therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | days/week | 12 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | days/week | 12 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Symptoms at post-treatment | 12 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Symptoms at post-treatment | 12 weeks |
|
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 0 |
| 28 |
| EG001 | 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 | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
Not provided
| D001519 |
| Behavior |
| D004191 | Behavioral Disciplines and Activities |