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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05162287
Other study ID # 2021-100618-BO-FF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date December 5, 2022

Study information

Verified date July 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study plan outlined here represents an investigation of instruments on the patients treated in the acute ward of child and adolescent psychiatry at the University Medical Center Hamburg Eppendorf (UKE). The psychosocial burden of the affected children and adolescents is evident due to the severity of the disorders leading to specific admission. The psychosocial burden can be defined as "psychological, social, or school-occupational functional impairment [...] that has arisen as a consequence of a mental disorder, a specific developmental disorder, or an intellectual impairment". The current research project aims to survey the severity of psychosocial distress, personality functioning impairment, and social withdrawal. A better knowledge of these factors may contribute to a more suitable, specialized treatment offer on the acute ward in the medium term.


Description:

Children and adolescents who receive inpatient psychiatric treatment are counted among the most impaired in society. In addition to the usually very severe mental disorders, the patient:s often have psychosocial risk factors and traumatic life events in their history. As demand for psychiatric-psychotherapeutic care increases, many inpatient services have been driven to reduce costs, while parallel pressures to measure outcomes and effectiveness have increased. The call for evidence-based practice underscores the need to use valid and reliable measurement tools to capture changes in symptoms and functionality during short-term interventions and their effectiveness. Measuring this change allows for the evaluation of the interventions as a whole and identifying areas for improvement. Acute care units are a particular type of inpatient setting. The main goal of treatment is to stabilize the patient:s by reducing acute psychiatric symptoms, suicide risk, and danger to others. The challenge of care for this target group is to do justice to heterogeneous initial situations and offer customized help for each child and adolescent. The use of instruments to record psychosocial stress and personality disorders increases the chance that at least some of those affected can be prevented from developing a chronic course and thus long-term psychosocial impairment utilizing tailored interventions.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date December 5, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion criteria - Patients treated in the acute ward of the Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics at the University Medical Center Hamburg-Eppendorf - Patients with a principal diagnosis of a psychiatric disorder (ICD-10-GM-2016: F10 - F90). - Patients under 18 years of age. Exclusion criteria - Patients with organic, including symptomatic mental disorders (F00 - F09) - Dementia / cognitive impairment (IQ < 70) - lack of German language skills - severe visual or hearing impairment (uncorrected).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (9)

Chanen A, Sharp C, Hoffman P; Global Alliance for Prevention and Early Intervention for Borderline Personality Disorder. Prevention and early intervention for borderline personality disorder: a novel public health priority. World Psychiatry. 2017 Jun;16(2):215-216. doi: 10.1002/wps.20429. No abstract available. — View Citation

Fonagy P, Speranza M, Luyten P, Kaess M, Hessels C, Bohus M. ESCAP Expert Article: borderline personality disorder in adolescence: an expert research review with implications for clinical practice. Eur Child Adolesc Psychiatry. 2015 Nov;24(11):1307-20. doi: 10.1007/s00787-015-0751-z. Epub 2015 Aug 14. — View Citation

Goth K, Birkholzer M, Schmeck K. Assessment of Personality Functioning in Adolescents With the LoPF-Q 12-18 Self-Report Questionnaire. J Pers Assess. 2018 Nov-Dec;100(6):680-690. doi: 10.1080/00223891.2018.1489258. — View Citation

Hall CL, Moldavsky M, Taylor J, Sayal K, Marriott M, Batty MJ, Pass S, Hollis C. Implementation of routine outcome measurement in child and adolescent mental health services in the United Kingdom: a critical perspective. Eur Child Adolesc Psychiatry. 2014 Apr;23(4):239-42. doi: 10.1007/s00787-013-0454-2. Epub 2013 Jul 30. No abstract available. — View Citation

Kronstrom K, Ellila H, Kuosmanen L, Kaljonen A, Sourander A. Changes in the clinical features of child and adolescent psychiatric inpatients: a nationwide time-trend study from Finland. Nord J Psychiatry. 2016 Aug;70(6):436-41. doi: 10.3109/08039488.2016.1149617. Epub 2016 Mar 22. — View Citation

Remschmidt, H., Schmidt, M. H., & Poustka, F. (2017). Multiaxiales Klassifikationsschema für psychische Störungen des Kindes- und Jugendalters nach ICD-10 (7th ed.). Hogrefe AG.

Schmeck, K., & Schlüter-Müller, S. (2021). Identitätsentwicklung als Fokus von psychodynamischer Kinder- und Jugendpsychotherapie. PDP - Psychodynamische Psychotherapie, 20(1), 28-39. https://doi.org/10.21706/pdp-20-1-28

Tharayil PR, Sigrid J, Morgan R, Freeman K. Examining Outcomes of Acute Psychiatric Hospitalization among Children. Soc Work Ment Health. 2012;10(3):205-232. doi: 10.1080/15332985.2011.628602. — View Citation

Yuan JM. HoNOSCA in an adolescent psychiatric inpatient unit: an exploration of outcome measures. Psychiatr Danub. 2015 Sep;27 Suppl 1:S357-63. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psychosocial distress HoNOSCA-D (Dölitzsch et al., 2020; von Wyl et al., 2017) The Health of the Nation Outcomes Scales for Children and Adolescents (HoNOSCA) is a questionnaire assessing psychosocial distress in children and adolescents. The 13-item instrument is a viable tool for differentiating the severity and social functioning of those with mental illness and can be used as a meaningful outcome instrument. It parallels a clinician's external assessment with a self-assessment. 7 minutes
Primary Psychosocial distress CGAS (Shaffer et al., 1983): adapted from the Global Assessment Scale for adults, the Children's Global Assessment Scale (CGAS) assesses functioning aimed at children and adolescents aged 6-17 years. The child or adolescent receives a single score ranging from 1 to 100 based on a clinician's assessment of several aspects of the child's psychological and social functioning. The score can be placed in one of ten categories ranging from "extremely impaired" to "very good" 3 minutes
Secondary Level of personality functioning SEFP (Falkai & Wittchen, 2015b): The level of personality functioning is dimensionally classified in the alternative DSM-5-PS model using the Level of Personality Functioning Scale. Criterion A is based on a normative functioning model of personality, from which there can be defined deviations, divided into four degrees of severity, regarding identity, self-control, empathy, and closeness. The SEFP is determined by an assessment by a clinician. 5 minutes
Secondary Level of personality functioning LoPF-Q 12-18 (Goth et al., 2018b): The Levels of Personality Functioning 12-18 Questionnaire (LoPF-Q 12-18) instrument assesses self-report impairments in personality functioning in the four domains of identity, self-control, empathy, and closeness in children and adolescents between the ages of 12 and 18. The test allows a dimensional differentiation between healthy and impaired personality functions, which are associated with a high risk of an existing personality disorder. 10 minutes
Secondary Social withdrawal YSR/11-18 (Döpfner et al., 2014): Social withdrawal is measured with nine items from the Youth Self-Report 11-18 (YSR/11-18), the social withdrawal subscale. The YSR is a widely used 112-item self-report scale of emotional and behavioral problems developed for children and adolescents ages 11 to 18. Items can be rated on a 3-point scale, where 0=not at all; 1=sometimes or not at all; and 2=always or often true in the past 6 months. 3 minutes
Secondary Social withdrawal 3-item Loneliness Scale (Klein et al., 2021): Social withdrawal is also measured by the 3-item Loneliness Scale. The scale is an economic measure derived from the R-UCLA Loneliness Scale (Russell et al., 1980) that captures basic aspects of loneliness: A sense of isolation, disconnectedness, and not belonging. Items are rated on 5-point Likert scales (0=never, 1=sometimes, 2=sometimes, 3=often, 4=very often). Responses are summed for a total score ranging from 0 to 12, with higher scores indicating higher levels of loneliness. 2 minutes
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