NCT03220581

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 9, 2021

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

July 14, 2017

Results QC Date

June 23, 2021

Last Update Submit

February 3, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Referral for care

ACTIVE COMPARATOR

Referral for mental health issues and family support services

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

Behavioral: Referral for careBehavioral: Behavioral therapy

Interventions

referral for addictions support

Behavioral therapyReferral for care

therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills

Behavioral therapy

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • parent/guardian of a 10-19 year old residing in the same household \>8 months/year
  • reports significant problems with game playing

You may not qualify if:

  • have a condition that may hinder study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

Referral and ConsultationBehavior Therapy

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

There were no major limitations of the trial.

Results Point of Contact

Title
Kristyn Zajac, PhD
Organization
UConn Health

Study Officials

  • Kristyn Zajac, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

October 1, 2017

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 7, 2022

Results First Posted

September 9, 2021

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations