Psychiatric DisorderNCT07559838
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.
A study testing Home treatment intervention in people with Psychiatric Disorder, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Home treatment intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Psychiatric Disorder
- Being tested
- Home treatment intervention
- Keywords
- home treatment, Home-Based Care, Outreach Treatment, Assertive Community Treatment, Children and Adolescents, Psychiatric Disorders, Community-Based Mental Health
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home treatment interventionBehavioural
Also called Outreach treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| home treatment | Experimental | Participants in this arm take part in the home treatment intervention. Receives: Behavioral: Home treatment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Nov 2023
- Primary completion31 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559838
- Sponsor's protocol ID
- 2025-0746-St
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Home Treatment in Child and Adolescent Psychiatry
- ClinicalTrials.gov ID
- NCT07559838
- Acronym / sponsor ID
- 2025-0746-St
- Conditions
- Psychiatric Disorder
- Keywords
- home treatment, Home-Based Care, Outreach Treatment, Assertive Community Treatment, Children and Adolescents, Psychiatric Disorders, Community-Based Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| home treatment | Experimental | Behavioral: Home treatment interventionParticipants in this arm take part in the home treatment intervention. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home treatment interventionAlso: Outreach treatmentParticipants 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. | Behavioural | home treatment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home treatment intervention in people with Psychiatric Disorder, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.