NCT02726880

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 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

March 31, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 28, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

4.5 years

First QC Date

March 31, 2016

Results QC Date

December 22, 2021

Last Update Submit

January 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Referral for care

ACTIVE COMPARATOR
Behavioral: Referral for care

Behavioral therapy

EXPERIMENTAL
Behavioral: Behavioral therapy

Interventions

6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.

Behavioral therapy

Referral for mental health issues and family support services

Referral for care

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 10-22 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

Behavior TherapyReferral and Consultation

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesProfessional PracticeOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Kristyn Zajac, PhD
Organization
UConn Health

Study Officials

  • Kristyn Zajac, Ph.D.

    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
Associate Professor

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 4, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 28, 2022

Results First Posted

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations