NCT07559838

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

April 15, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

home treatmentHome-Based CareOutreach TreatmentAssertive Community TreatmentChildren and AdolescentsPsychiatric DisordersCommunity-Based Mental Health

Outcome Measures

Primary Outcomes (1)

  • Change in biopsychosocial symptom severity

    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 Outcomes (1)

  • Change in Self- and Caregiver-Reported Functional Impairment

    From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended

Study Arms (1)

home treatment

EXPERIMENTAL

Participants in this arm take part in the home treatment intervention.

Behavioral: Home treatment intervention

Interventions

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.

Also known as: Outreach treatment
home treatment

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 30, 2026

Study Start

November 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations