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.

April 27, 2026 updated by: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University of Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: home treatment
Participants in this arm take part in the home treatment intervention.
Behavioral: 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.
Other Names:
  • Outreach treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in biopsychosocial symptom severity
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self- and Caregiver-Reported Functional Impairment
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0746-St

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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