NCT05506384

Brief Summary

The aim of the study is twofold: 1) to evaluate an Relaps Prevention(RP) treatment for Problematic Gaming (PG) and Internet Gaming Disorder (IGD) patients recruited from child and youth psychiatry (CAP) clinics and 2) to test whether the quality of parent-child relationships plays role in the effect of RP treatment and vice versa - whether the RP treatment has a spillover effect on the quality of parent-child relationships.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

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

Study Start

First participant enrolled

May 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

August 8, 2022

Last Update Submit

February 29, 2024

Conditions

Keywords

GamingGamblingAdolescentChildren

Outcome Measures

Primary Outcomes (2)

  • Gaming changes

    Changes in gaming measured with Game Addiction Scale for Adolescents (GASA) . GASA applies to gaming behavior during the last 6 months with 7 items. Each question covers one criterion in the Diagnostic and Statistical Manual 5 (DSM-5), answered on a 5-point Likert scale ranging from 1 (never) to 5 (very often) and should according to the developer be counted as endorsed when rated 3 or higher. Min: 0 Max: 35 A higher outcome means worse gaming problems

    treatment and 3 months

  • Gambling changes

    Changes in gambling measured with National Opinion Research Center (NORC) Diagnostic Screen for Gambling Disorders (NODS), three NODS questions, pertaining to loss of Control, Lying, and Preoccupation (CLiP). NODS-CLiP is the shorter form of NODS. Min: 0 Max:3 A higher outcome means worse gambling problems.

    treatment and 3 months

Secondary Outcomes (1)

  • Family climate/communication

    treatment and 3 months

Study Arms (2)

Relaps prevention treatment

EXPERIMENTAL

The treatment will be administered in an individual format and consist of seven to nine sessions of 45 minutes over a period of seven to nine weeks. The number of sessions can vary to be able to accommodate the fact that participants may have different levels of motivation for changing their primary problem behavior, which is why some participants may require one or two extra sessions at the start of the treatment. The treatment will be offered to participants both in person and via video link to facilitate participation for children and adolescents living further away from the participating clinics.

Behavioral: Relaps Preventions Therapy

Treatment as usual

OTHER

The patients in this arm will get treatment as usual at their Child and Adolescent psychiatry clinic.

Behavioral: Treatment as usual

Interventions

The treatment consists of three parts: 1) setting goals, 2) understanding and identifying high-risk situations and problem behaviors, and 3) consolidating the new activity schedule and identifying future high-risk behaviors. The first part is focused on examining the patient's undesirable behavior, his/her motivation for change, and establishing goals with the. The second part, drawing more from traditional Cognitive Behavioral Therapy (CBT) techniques, consists of exploring problematic situations, identifying high-risk situations and events, emotions and cognitions that induce the problematic gaming behavior or result in a relapse; managing game time with activity scheduling and practicing problem-solving skills. The final part consists of recognizing early warning signals that may indicate that the primary problem behavior is more likely to occur and consolidating the parts of the treatment that have been most helpful in maintaining the new activity schedule.

Relaps prevention treatment

This group will receive treatment as usual at their Child and Adolescent Psychiatry Clinic.

Treatment as usual

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 12-18
  • over cut-off on GASA
  • over cut-off on CLiP

You may not qualify if:

  • not being able to speak Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and adolescent Clinic Rehion Skane

Lund, Sweden

Location

Related Publications (2)

  • Andre F, Kapetanovic S, Einarsson I, Trebbin Harvard S, Franzen L, Mottus A, Hakansson A, Claesdotter-Knutsson E. Relapse prevention therapy for internet gaming disorder in Swedish child and adolescent psychiatric clinics: a randomized controlled trial. Front Psychiatry. 2023 Oct 20;14:1256413. doi: 10.3389/fpsyt.2023.1256413. eCollection 2023.

  • Kapetanovic S, Gurdal S, Einarsson I, Werner M, Andre F, Hakansson A, Claesdotter-Knutsson E. Relapse Prevention Therapy for Problem Gaming or Internet Gaming Disorder in Swedish Child and Youth Psychiatric Clinics: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 5;12:e44318. doi: 10.2196/44318.

MeSH Terms

Conditions

GamblingInternet Addiction Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersTechnology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive Behavior

Study Officials

  • Emma Claesdotter-Knutsson, MD;PhD

    emma.claesdotter-knutsson@skane.se

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 18, 2022

Study Start

May 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations