Treatment Study for Problematic Gaming and Gambling

Pathological Gambling Clinical Trial

Official title:

Treatment Study for Problematic Gaming and Gambling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05506384
• Other study ID #: 2019-04797
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion criteria

• age 12-18

• over cut-off on GASA

• over cut-off on CLiP

Exclusion criteria

• not being able to speak Swedish

Related Conditions & MeSH terms

• Gambling
• Internet Gaming Disorder
• Pathological Gambling

Intervention

Behavioral:
• Relaps Preventions Therapy
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.
• Treatment as usual
This group will receive treatment as usual at their Child and Adolescent Psychiatry Clinic.

Locations

Country	Name	City	State
Sweden	Child and adolescent Clinic Rehion Skane	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	treatment and 3 months