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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: ISRCTN
Last refreshed on: 15 November 2021
Main ID:  ISRCTN02672532
Date of registration: 11/08/2014
Prospective Registration: No
Primary sponsor: University of Ulm
Public title: BeZuHG - Being treated at home for mental reconvalescence (Behandelt zu Hause Gesund Werden)
Scientific title: Effectiveness of home treatment supplemented by clinical elements versus regular in-patient care in children and adolescents with psychiatric disorders
Date of first enrolment: 01/10/2011
Target sample size: 292
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN02672532
Study type:  Interventional
Study design: 
Part one and three: randomized controlled trial
Part two: case-series (Treatment)
 
Phase:  Not Applicable
Countries of recruitment
Germany
Contacts
Name: Isabel    Boege
Address:  Child and Adolescent Psychiatry ZfP-Suedwuerttemberg Weingartshoferstrasse 2 88212 Ravensburg Germany
Telephone: +49 (0)751 7601 2405
Email: Isabel.Boege@zfp-zentrum.de
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Mental disorders in children and adolescents requiring inpatient care
Mental and Behavioural Disorders
Intervention(s)

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,
Primary Outcome(s)

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)
Secondary Outcome(s)

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)
Secondary ID(s)
Versorgungsforschung Baden-Wurttemberg D.3747, ZfP-Suedwuerttemberg Kostenstelle 2562088
Source(s) of Monetary Support
Health Services Research Baden-Württemberg, Junior academy, subdivision University of Ulm, Baden-Württemberg [Versorgungsforschung Baden Wuerttemberg, Nachwuchsakademie, University of Ulm] (Germany), Zfp-Südwürttemberg (Germany)
Secondary Sponsor(s)
ZfP-Suedwuerttemberg
Ethics review
Status:
Approval date:
Contact:
Ethics Committee of the University of Ulm, 20/09/2011, ref. 214/11
Results
Results available: Yes
Date Posted:
Date Completed: 30/09/2016
URL:
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