- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Medical University of Innsbruck
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in biopsychosocial symptom severity
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Self- and Caregiver-Reported Functional Impairment
Lasso di tempo: 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
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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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-0746-St
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