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临床试验/NCT05506384
NCT05506384已完成不适用

Treatment Study for Problematic Gaming and Gambling

Region Skane1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
160
试验地点
1
主要终点
Gambling changes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Gambling changes

时间窗: treatment and 3 months

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.

Gaming changes

时间窗: treatment and 3 months

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

次要结局

  • Family climate/communication(treatment and 3 months)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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