跳至主要内容
临床试验/NCT04094324
NCT04094324Enrolling By Invitation不适用

Mental Health in Children and Youth Within Pediatric Care.

Region Skane2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Region Skane
入组人数
200
试验地点
2
主要终点
Changes in ISO-BMI

研究概览

简要总结

Over the last decades, there has been an increase in the number of children and youth with mental illness, such as anxiety and depression. Mental illness in youth has a strong negative influence on the youth's quality of life and generally leads to dysfunction in several important areas, such as school and social activities. Early detection and treatment of mental illness entails great treatment benefits, and thus provide opportunity to prevent or reduce individual suffering.

Youth who suffer från Medical conditions, such as diabetes, epilepsy, gastro-intestinal disease, and obesity, show an increased risk of developing mental illness. There are well-established, careful programs for examining somatic co-morbidities to diseases in children and youth. Currently, despite the fact that mental illness is more common in these children than medical sequelae and despite that such a procedure is recommended, no routine exist for examining mental health in children and youth presenting for treatment at pediatric clinics in Skåne. The absence of such a general screening entails that mental illness rarely is recognized by medical care providers until it has become severe.

The purpose of this study is to describe the prevalence of mental illness in children and adolescents, 11-18 years of age, that undergo Medical treatment at a Clinic for children and youth. Groups recruited for the first part of the study are obesity clinics and gastro clinics. In addition, we want to examine if mental health affects outcome success in their medical treatment. The long-term main objective of this project is early discovery and treatment of mental illness in somatically ill children and youth, thereby preventing the development of severe mental illness, and to reduce suffering.

By the end of the project we will have a well-functioning routine for examining mental health status in 11-18 years olds that present for and undergo treatment in Clinics for children and youth in Skåne. Furthermore, we hope that the screening tool can contribute to, and affect, nationally established guide-lines regarding the discovery and treatment of mental illness in children and adolescents within pediatric care.

详细描述

Children and youth, 11-18 years of age, that receive treatment for obesity or Irritable Bowel Disease (IBD), will be asked to fill out three questionnaires on an iPad during a regular visit at their clinic. Information about the study will be sent home before the visit, and will be repeated again at the clinic.

The questionnaires takes about 10-15 minutes in total to answer, and the Child will be able to sit in a separate room while answering. The questionnaires are well validated screening tools for various forms of mental illness; General anxiety disorder 7 item scale (GAD-7) (anxiety), Psycic Health questionnaire 8 items (PHQ-8) (depression), The Child Eating Disorder Examination 8 items (ChEDE-Q8) (eating habits), and Pediatric quality of Life inventory (PedsQL).

Patients that receive high scores will be offered a psychologist appointment for further evaluation and treatment (e. g. individual- or family centered therapy).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Children and youth who are patients at a pediatric clinic in Region Skåne SUS(obesity, gatronomy)

排除标准

  • Children who are unable to reply qustions on an iPad, due to language difficulties or cognitive challenges.

结局指标

主要结局

Changes in ISO-BMI

时间窗: 2021-2022

Measures treatment outcome in obese Children by comparing ISO-BMi levels 1y apart.

General anxiety scale 7 items (GAD-7)

时间窗: 2020-2022

Self-reported signs of anxiety Minimum maximum score: 0-3 Total: 21 Better or worse score: 0= never (never experiences anxiety) 4=daily (experiences anxiety daily). High score = excessive feelings of anxiety

The Eating Disorder Examination-Questionnaire for children (ChEDE-Q8)

时间窗: 2020-2022

Self-reported eating habits Minimum maximum score: 0-6 Total: 48 Better or worse score: 0= never (no problematic eating habits) 6=daily (very problematic eating habits). High svore = very problematic eating habits

The psychic health questionnaire 8 items (PHQ-8)

时间窗: 2020-2022

Self-reported signs of depression Minimum maximum score: 0-3 Total: 24 Better or worse score: 0= never (never experiences depressive thoughts) 4=daily (experiences depressive thoughts daily). High score = high levels of depression

Changes in F-kalprotectin levels

时间窗: 2021-2022

Measures treatment outcome in Children with iriitable bowel disease (IBD) by comparing levels 1y apart.

Pediatric quality of Life scale (PedsQL) 23 items

时间窗: 2020-2022

Self-reported quality of life. Measures feelings of generel well-being Minimum maximum score: 0-4 Total: 92 Better or worse score: 0= never (never experiences well-being) 4=daily (experiences well-being daily). High score = good genereal well-being

次要结局

未报告次要终点

研究者

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

研究点 (2)

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