跳至主要内容
临床试验/NCT02773706
NCT02773706已完成不适用

Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties

Indiana University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Quality of life (baseline)

研究概览

简要总结

The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.

详细描述

SPECIFIC AIMS: Mental Health and Quality of Life in Children with Gastrointestinal Disorders Depression and anxiety are two of the most common and dangerous disorders in childhood and adolescence. Currently, a large proportion of children with these disorders remain unrecognized or untreated resulting in considerable morbidity and mortality. The rates of depression and anxiety are significantly higher in children with chronic illnesses, including gastrointestinal disorders, than in the general population. Furthermore, children with depression or anxiety are far more likely to have somatic complaints, and have greater utilization of subspecialty care, especially in gastroenterology. Functional gastrointestinal disorders such as irritable bowel syndrome, chronic recurrent abdominal pain, and functional dyspepsia frequently have comorbid anxiety or depression.

Efforts to recognize and treat mental health problems in children with chronic medical illness, such as gastrointestinal disorders, have been shown to improve adherence to therapy, as well as other clinical outcomes. More importantly, improving such mental health problems might go far to addressing the outcomes patients care about most with respect to their gastroenterological disease. Unfortunately, mental health resources are often difficult for families to access, even when these disorders are recognized.

Validated screening tools exist to screen for anxiety and depression in children and adolescents, including the Screen for Childhood Anxiety Related Emotional Disorders (SCARED) and the Patient Health Questionnaire (PHQ-9). Despite the established importance of depression and anxiety in the gastrointestinal health of children and adolescents, few data exist describing the treatment of anxiety and depression by pediatric gastroenterologists. Furthermore, little is known about how families or patients view the subspecialty office as the setting to detect or care for mental illness. Additionally, if anxiety and depression are identified by the gastroenterologist, many practitioners find either they have limited training and expertise in the management of adolescent mental health disorders, or they encounter barriers to referral to a mental health specialist, especially in children with public insurance.

Therefore, the specific aims of this research project are to:

Aim 1: Determine family and patient attitudes towards tools to screen for mental illness in a pediatric subspecialty office utilizing structured interviews.

研究设计

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

入排标准

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

入选标准

  • All patients seen at the pediatric GI office who are screened for anxiety and depression as part of usual care.

排除标准

  • Patients over the age of 18 or under the age of 10.

结局指标

主要结局

Quality of life (baseline)

时间窗: Baseline

Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)

Quality of life (followup)

时间窗: Within 6 months

Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)

次要结局

  • Utilization of endoscopy(Within 6 months)
  • Utilization of outpatient gastroenterology(6 months)
  • Utilization of laboratory testing(6 months)
  • Utilization of radiologic testing(6 months)
  • Utilization of emergency department visits(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William E. Bennett, Jr.

Assistant Professor of Pediatrics

Indiana University

研究点 (2)

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