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临床试验/NCT05211713
NCT05211713已完成不适用

Opp: The Development and Evaluation of a Mental Health App for Adolescents

University of Tromso1 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
399
试验地点
1
主要终点
Change in WHO-5 (WHO-Five Well-being Index)

研究概览

简要总结

The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.

详细描述

The intervention "Opp" will be delivered through a mobile application. The overall goals of Opp are to 1) increase well-being and mental well-being, 2) increase knowledge about mental health, 3) increase coping skills to deal with stress, 4) increase help-seeking behavior, 5) increase self-esteem, 6) increase sleep quality and 7) reduce mental health problems.

To evaluate the mobile application two studies will be conducted: A user survey and an effectiveness study with a follow-up examination after about six weeks. The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents under 16 years whose guardians have given consent

排除标准

  • severe developmental or cognitive challenges

研究组 & 干预措施

Intervention group receiving Opp

Experimental

The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group. Data will be collected at baseline (T1, pre intervention) and after about six weeks of intervention (T2, post intervention).

干预措施: Opp (Device)

Control group

No Intervention

The waiting list control group will receive the intervention after study completion.

结局指标

主要结局

Change in WHO-5 (WHO-Five Well-being Index)

时间窗: Change from baseline to six weeks after intervention.

WHO-5 (WHO, 1998): A five item self-report questionnaire assessing well-being on a six point scale.

Change in SDQ (Strengths and Difficulties Questionnaire)

时间窗: Change from baseline to six weeks after intervention.

SDQ (Goodman, 1997): A 25 item self-report assessing mental health and psychosocial functioning in 11-17 years old adolescents on a three point scale.

次要结局

  • General Self-efficacy scale (GSE)(Change from baseline to six weeks after intervention.)
  • Help-seeking behavior(Change from baseline to six weeks after intervention.)
  • Sleeping quality(Change from baseline to six weeks after intervention.)
  • Self-liking and Competence Scale(Change from baseline to six weeks after intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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