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Treatment Study for Problematic Gaming and Gambling

Primary Purpose

Pathological Gambling, Internet Gaming Disorder

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Relaps Preventions Therapy
Treatment as usual
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling focused on measuring Gaming, Gambling, Adolescent, Children

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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

Exclusion criteria

  • not being able to speak Swedish

Sites / Locations

  • Child and adolescent Clinic Rehion Skane

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Relaps prevention treatment

Treatment as usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Family climate/communication
Changes in family climate/communication. Parent-child communication includes six subscales. Items are rated on a five-point Likert scale ranging from 1 (often) to 5 (Never). Min: 0 Max: 30 A higher outcome means worse communication. Family climate , includes two subscales, family cohesion and conflict. While family cohesion assesses the bonds between family members, family conflict assesses the conflicts between family members. A total of 11 questions. Items are rated on a four-point scale, ranging from 1 (not true at all) to 4 (very true). Min: 0 Max: 44 A higher outcome means worse family climate.

Full Information

First Posted
August 8, 2022
Last Updated
January 31, 2023
Sponsor
Region Skane
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT05506384
Brief Title
Treatment Study for Problematic Gaming and Gambling
Official Title
Treatment Study for Problematic Gaming and Gambling
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is a two-arm, parallel-group, single-blind, early-stage Randomized Clinical Trial (RCT) with embedded qualitative components. Participants will be randomized in a 1:1 ratio to either intervention or control, with a total of 162 participants (81+81) in the trial. The primary outcomes are measures of gaming and gambling behavior pre- and post-intervention, and the secondary outcomes include child ratings of parent-child communication, including parental knowledge, control and solicitousness about child gaming, as well as child disclosure and secrecy related to gaming. Preliminary analyses will be conducted with regression analyses, paired sample t-tests and ANOVAs and performed in Mplus. In addition to the RCT, the study will be supplemented with a qualitative component with semi-structured individual interviews to capture participants' and clinicians' experiences of the treatment, as well as attitudes about parent-child relationships and parenting needs in carers whose children completed the RP treatment. The qualitative data will be analyzed with thematic analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling, Internet Gaming Disorder
Keywords
Gaming, Gambling, Adolescent, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relaps prevention treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
The patients in this arm will get treatment as usual at their Child and Adolescent psychiatry clinic.
Intervention Type
Behavioral
Intervention Name(s)
Relaps Preventions Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
This group will receive treatment as usual at their Child and Adolescent Psychiatry Clinic.
Primary Outcome Measure Information:
Title
Gaming changes
Description
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
Time Frame
treatment and 3 months
Title
Gambling changes
Description
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.
Time Frame
treatment and 3 months
Secondary Outcome Measure Information:
Title
Family climate/communication
Description
Changes in family climate/communication. Parent-child communication includes six subscales. Items are rated on a five-point Likert scale ranging from 1 (often) to 5 (Never). Min: 0 Max: 30 A higher outcome means worse communication. Family climate , includes two subscales, family cohesion and conflict. While family cohesion assesses the bonds between family members, family conflict assesses the conflicts between family members. A total of 11 questions. Items are rated on a four-point scale, ranging from 1 (not true at all) to 4 (very true). Min: 0 Max: 44 A higher outcome means worse family climate.
Time Frame
treatment and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria age 12-18 over cut-off on GASA over cut-off on CLiP Exclusion criteria not being able to speak Swedish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Claesdotter-Knutsson, MD;PhD
Organizational Affiliation
emma.claesdotter-knutsson@skane.se
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and adolescent Clinic Rehion Skane
City
Lund
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment Study for Problematic Gaming and Gambling

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