Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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15 November 2021 |
Main ID: |
ISRCTN02672532 |
Date of registration:
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11/08/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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BeZuHG - Being treated at home for mental reconvalescence (Behandelt zu Hause Gesund Werden)
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Scientific title:
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Effectiveness of home treatment supplemented by clinical elements versus regular in-patient care in children and adolescents with psychiatric disorders |
Date of first enrolment:
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01/10/2011 |
Target sample size:
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292 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN02672532 |
Study type:
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Interventional |
Study design:
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Part one and three: randomized controlled trial Part two: case-series (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Germany
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Contacts
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Name:
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Isabel
Boege |
Address:
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Child and Adolescent Psychiatry ZfP-Suedwuerttemberg
Weingartshoferstrasse 2
88212
Ravensburg
Germany |
Telephone:
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+49 (0)751 7601 2405 |
Email:
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Isabel.Boege@zfp-zentrum.de |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Part one and two: Hospital inpatient stay for more than 72 hours
All parts: 1. Age: Between 5 and 18 years 2. Psychiatric diagnosis (DSM IV/ICD10) 3. Child/adolescent lives in a family setting 4. Youth and family live within the catchment area in a reasonable distance (max 1 hour travel) to allow home treatment on a regular basis 5. IQ> 70
Exclusion criteria: 1. Youth lives in a youth welfare setting 2. Absence of consent of parents or child/youth 3. Limited language skills in families whose first language is not German
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mental disorders in children and adolescents requiring inpatient care Mental and Behavioural Disorders
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Intervention(s)
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Control: 146 adolescents will receive usual inpatient care Intervention: 96 patients will be discharged early with intensive community support in combination with clinical elements provided by BeZuHG. 50 patients will receive directly the intensive community support via BeZuHG, without inpatient admission.
BeZuHG is a newly established service for children and adolescents with a psychiatric disorder requiring inpatient admission, which is aiming to improve: 1. Familial and peer-group reintegration 2. Minimize school disruption 3. Decrease stigma 4. Reduce / or avoid overall length of stay by providing an alternative care pathway BeZuHG is provided by a team of Band 7/8 nurses, a psychologist and a psychiatrist offering intensive community support as well as access to clinical structures usually unavailable for outpatients. In summary the aim of BeZuHG is: 1. To facilitate early discharge or even avoid admission at all by offering intensive community support 2. To enhance therapeutic engagement 3. To enable and enhance early reintegration into the familial, social and school environment 4. To reduce the risk of future readmission 5. To reduce financial cost associated with children and adolescents requiring in-patient care due to mental illness 6. To improve patient and carer satisfaction
BeZuHG treatment is individualized according to need (patient and carer). Elements are intensive case management including cooperation with schools and social services, home treatment, day care, hospital schooling, group therapies,
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Primary Outcome(s)
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Generally there are 3 timepoints for both primary and secondary outcomes at which data is collected: T1 - within 14 days after inclusion into the study T2 - after completion of treatment (control group: discharge from inpatient stay, intervention group: completion of BeZuHG treatment) T3 - 6 month follow up
1. Duration of psychiatric inpatient stay during treatment and a 6 month follow-up period (i.e. T2 and T3) 2. CGAS (Childrens global assessment Scale) This is a paediatric measure of general functioning (T1, T2 and T3)
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Secondary Outcome(s)
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1. SDQ (strengths and difficulties questionnaire, childrens and parents version) This is a broad measure of psychopathology in children and adolescents (T1, T2 and T3) 2. HoNOSCA (Health of the Nation Outcome Scales for Children and Adolescents). It is a clinician rated tool, that assesses symptom severity and function across a range of psychosocial domains (T1, T2 and T3) 3. ZUF 8 (Fragebogen zur Patientenzufriedenheit - Questionnaire for service satisfaction) (T2 and T3) 4. Qualitative semi-structured interview regarding patient satisfaction (T3) 5. Cost: Information on the use of inpatient hospital services, community services, out-patient services, social services, school support will be collected over the study period (T2 and T3) 6. Clinical diagnosis: K-SADS-PL (schedule for affective disorders and Schizophrenia for school-age children, Present and Lifetime Version) (T1) 7. Columbia Impairment Scale (T1, T2 and T3)
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Secondary ID(s)
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Versorgungsforschung Baden-Wurttemberg D.3747, ZfP-Suedwuerttemberg Kostenstelle 2562088
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Source(s) of Monetary Support
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Health Services Research Baden-Württemberg, Junior academy, subdivision University of Ulm, Baden-Württemberg [Versorgungsforschung Baden Wuerttemberg, Nachwuchsakademie, University of Ulm] (Germany), Zfp-Südwürttemberg (Germany)
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committee of the University of Ulm, 20/09/2011, ref. 214/11
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/09/2016 |
URL:
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