- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05162287
Child and Adolescent Psychiatric Personality Structure (CAPPS)
July 18, 2023 updated by: Johannes Boettcher, Universitätsklinikum Hamburg-Eppendorf
Psychosocial Distress, Levels of Personality Functioning, and Social Withdrawal in a Child and Adolescent Psychiatric Acute Inpatient Population
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.
Study Overview
Status
Completed
Detailed 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.
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Johannes Boettcher, M.Sc.
- Phone Number: 01781323472
- Email: j.boettcher@uke.de
Study Contact Backup
- Name: Carola Bindt, PD Dr.
- Phone Number: +49 40 7410 54585
- Email: bindt@uke.de
Study Locations
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Hamburg, Germany, 20251
- University Medical Center Hamburg-Eppendorf
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Clinical study participants for the diagnostic study are patients between the ages of 12 and 17 who are undergoing treatment for a psychiatric illness in the acute care unit of the Child and Adolescent Psychiatry Department at the University Medical Center Hamburg-Eppendorf.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients who are treated in the acute ward of the child and adolescent psychiatry
All children and adolescents aged 12 to 18 years who are treated in the acute ward of the Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics at the University Medical Center Hamburg-Eppendorf are recruited.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial distress
Time Frame: 7 minutes
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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.
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7 minutes
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Psychosocial distress
Time Frame: 3 minutes
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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"
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3 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of personality functioning
Time Frame: 5 minutes
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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.
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5 minutes
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Level of personality functioning
Time Frame: 10 minutes
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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.
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10 minutes
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Social withdrawal
Time Frame: 3 minutes
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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.
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3 minutes
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Social withdrawal
Time Frame: 2 minutes
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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.
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2 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Johannes Boettcher, M.Sc., Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
- Study Director: Carola Bindt, PD Dr., Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
- Principal Investigator: Ursula Völker, Dr., Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Remschmidt, H., Schmidt, M. H., & Poustka, F. (2017). Multiaxiales Klassifikationsschema für psychische Störungen des Kindes- und Jugendalters nach ICD-10 (7th ed.). Hogrefe AG.
- 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.
- 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.
- 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.
- Yuan JM. HoNOSCA in an adolescent psychiatric inpatient unit: an exploration of outcome measures. Psychiatr Danub. 2015 Sep;27 Suppl 1:S357-63.
- 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
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
December 5, 2022
Study Registration Dates
First Submitted
November 10, 2021
First Submitted That Met QC Criteria
December 4, 2021
First Posted (Actual)
December 17, 2021
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 18, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-100618-BO-FF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is not yet decided if there will be a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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