- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07559838
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.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tyrol
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Innsbruck, Tyrol, Oostenrijk, 6020
- Medical University of Innsbruck
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: home treatment
Participants in this arm take part in the home treatment intervention.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in biopsychosocial symptom severity
Tijdsspanne: From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended.
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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.
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From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Self- and Caregiver-Reported Functional Impairment
Tijdsspanne: From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended
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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
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From enrollment to the end of treatment at 12 weeks as well as 6 months after treatment has ended
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025-0746-St
Plan Individuele Deelnemersgegevens (IPD)
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