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The Pilot Study "Home Treatment in Child and Adolescent Psychiatry" Aims to Evaluate the Effectiveness of a 3-month Home-based Intervention as an Alternative to an Inpatient Stay at a Psychiatric Clinic. Participants Are Children and Adolescents With Current Psychiatric Conditions.

2026年4月27日 更新者:Medical University Innsbruck

Pilot Study: Home Treatment in Child and Adolescent Psychiatry

This study investigates the effectiveness of an intervention for children and adolescents with psychiatric disorders. The core concept is the provision of treatment in the patient's home environment as an alternative to, and substitute for, inpatient psychiatric care. Patients receive between 3 and 7 treatment sessions per week over a period of 3 months. A multidisciplinary team-comprising a physician, psychologist, social worker, occupational therapist, dietitian, and educational specialist-delivers assessments and interventions on site. Participation in the program is offered as a voluntary alternative to hospitalization.

The study is designed as a single-arm pragmatic trial. The primary outcome is the change in clinical symptom severity and psychosocial functioning, as assessed by the study physician. A follow-up assessment will be conducted after 6 months to evaluate long-term effectiveness.

In addition to the primary outcome, both patients and their legal guardians provide self-reports on psychosocial functional impairment. Changes in functional impairment constitute the secondary outcome.

For comparative purposes, outcomes will be contrasted with a historical control group consisting of inpatient participants.

研究概览

地位

主动,不招人

条件

研究类型

介入性

注册 (实际的)

43

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tyrol
      • Innsbruck、Tyrol、奥地利、6020
        • Medical University of Innsbruck

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Sufficient proficiency in the German language
  • Age between 6 and 18 years
  • Residence within approximately a 30-minute driving distance from the hospital
  • Willingness and ability of patient and caregivers to comply with treatment appointments
  • Clinical indication for psychiatric treatment

Exclusion Criteria:

  • Immediate threats to the child's safety or well-being in the home environment
  • Current risk of harm to self or others
  • Current violent behavior
  • Inability of patient or caregivers to adhere to treatment appointments
  • Lack of motivation or insufficient engagement leading to inability to participate in treatment
  • No exclusion based on specific psychiatric diagnoses

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:home treatment
Participants in this arm take part in the home treatment intervention.
Participants receive an intensive home-based psychiatric treatment program as an alternative to inpatient hospitalization. The intervention is delivered in the participants' home environment over a period of 3 months and consists of 3 to 7 treatment sessions per week. A multidisciplinary team composed of a physician, psychologist, social worker, occupational therapist, dietitian, and educational specialist provides integrated on-site assessment and treatment. The intervention includes clinical evaluation, psychotherapeutic and psychosocial interventions, medication management, functional support, and family involvement as needed.
其他名称:
  • Outreach treatment

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in biopsychosocial symptom severity
大体时间:From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended.
The Health of the Nation Outcome Scale for Children (HoNOSCA) (Gowers et al., 1999) is a clinician-rated scale used to assess the biopsychosocial severity of mental health problems in children and adolescents. The scale is composed of two sections and 15 items. Section one, comprising items 1-13, relates to different types of well-being issues, such as behavioral difficulties, clinical symptoms, social difficulties, and impairment. Section two, comprising items 14-15, relates to difficulties in understanding the nature of the underlying issues as well as knowledge of available resources. Symptoms are rated on a 5-point Likert scale, ranging from 0 (no problem at all) to 4 (severe problem); thus, higher scores imply greater severity of difficulties with a score range of 0-60. A sum score is calculated to represent the overall psychopathological state. Initial psychometric testing showed satisfactory reliability and validity, and the scale is sensitive to change.
From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended.

次要结果测量

结果测量
措施说明
大体时间
Change in Self- and Caregiver-Reported Functional Impairment
大体时间:From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended
The Columbia Impairment Scale (CIS) (Bird et al., 1993) is an instrument used to measure psychological functional impairment. Functional impairment refers to the extent to which presenting symptoms affect an individual's capacity to function adaptively across multiple contexts, such as at home, at school, at work, or in relationships with others, including parents, siblings, or friends. The scale is composed of 13 items, with responses given on a 4-point Likert scale ranging from zero (no problem at all) to four (very severe problem). These items are divided into four domains: interpersonal relations, broad psychopathological domains, use of leisure time, and functioning in school or at work. Sum scores are reported as an overall indicator of impairment; higher scores imply greater impairment with a score range of 0-52
From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年11月1日

初级完成 (实际的)

2025年12月31日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年4月15日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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