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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009241 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The fifth revision of the Diagnostic and Statistical Manual for Mental Disorders includes in its research appendix a potential new diagnosis-Internet gaming disorder. This condition primarily affects adolescent boys and young adult men, who rarely seek treatment on their own. More often, parents express concerns about their child's game playing behaviors. This psychotherapy development study will evaluate feasibility and effect sizes of an intervention designed to help parents reduce their child's gaming problems; the intervention allows for child participation, but it is geared toward parents, regardless of whether or not their child is willing to participate. A total of 40 parents concerned about their child's gaming behaviors will complete self and parental report inventories and structured diagnostic interviews regarding gaming, substance use and psychosocial functioning. Children who elect to participate will complete parallel versions of the instruments. Participants will be randomized to a control condition consisting of referral for mental health issues and family support services or to a 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors. Gaming and other problems will be assessed pre-treatment, at the end of treatment and at a 4-month follow-up. This study will be the first to evaluate the reliability and validity of a parental version of the fifth revision of the Diagnostic and Statistical Manual for Mental Disorders criteria for internet gaming disorder in a clinical sample, and it will assess associations of internet gaming disorder with substance use, mental health conditions, and family functioning as well. This study will be the first randomized trial of an intervention designed to assist parents in reducing their child's gaming problems, and results will help guide future development of interventions for Internet gaming disorder. To evaluate the feasibility and acceptability of this intervention, the proportion of parents assigned to the intervention who complete 6 sessions will be examined, as will the proportion of youth who attend the sessions. Parent and child ratings of satisfaction with the intervention will be assessed. To examine the effect size of the intervention on reducing gaming, parental reports of proportion of days on which their child played games and durations of game playing will be compared between conditions, controlling for baseline indices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referral for care | Active Comparator |
| |
| Behavioral therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral therapy | Behavioral | 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Complete All 6 Sessions | Completion of sessions is an indicator of treatment acceptability and feasibility | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristyn Zajac, Ph.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Referral for Care | Referral for care: Referral for mental health issues and family support services |
| FG001 | Behavioral Therapy | Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Referral for Care | Referral for care: Referral for mental health issues and family support services |
| BG001 | Behavioral Therapy | Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors. |
| 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 Complete 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 |
|
|
16 weeks
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| 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 care: Referral for mental health issues and family support services |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hernia operation | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit for car accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristyn Zajac, PhD | UConn Health | 860-679-8572 | zajac@uchc.edu |
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| 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 | May 9, 2020 | Jun 25, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2020 | Jun 25, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000082424 | Internet Addiction Disorder |
| ID | Term |
|---|---|
| D000088942 | Technology Addiction |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
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| Referral for care | Behavioral | Referral for mental health issues and family support services |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age in years is reported for the parents who participated in the study. The intervention was focused on child gaming behavior but the children were not required to participate in the study. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of days of gaming in the past week - reported by parent | Mean | Standard Deviation | days |
|
| Counts |
|---|
| Participants |
|
|
| 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 sample size for this analysis is smaller than the overall sample because several participants were lost to follow up. | Posted | Mean | Standard Deviation | days | 12 weeks |
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|
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| 0 |
| 17 |
| EG001 | Behavioral Therapy | Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors. | 0 | 19 | 0 | 19 | 1 | 19 |
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| D001519 |
| Behavior |
| D006298 | Health Services Administration |