NCT05162287

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

November 10, 2021

Last Update Submit

July 18, 2023

Conditions

Keywords

acute adolescent psychiatric units

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Level of personality functioning

    5 minutes

  • Level of personality functioning

    10 minutes

  • Social withdrawal

    3 minutes

  • Social withdrawal

    2 minutes

Study Arms (1)

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.

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (9)

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

    BACKGROUND
  • 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.

    PMID: 27002640BACKGROUND
  • 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.

    PMID: 23896764BACKGROUND
  • 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.

    PMID: 23946699BACKGROUND
  • Yuan JM. HoNOSCA in an adolescent psychiatric inpatient unit: an exploration of outcome measures. Psychiatr Danub. 2015 Sep;27 Suppl 1:S357-63.

    PMID: 26417796BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 30907712BACKGROUND
  • 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.

    PMID: 26271454BACKGROUND
  • 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.

    PMID: 28498598BACKGROUND

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Johannes Boettcher, M.Sc.

    Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics

    PRINCIPAL INVESTIGATOR
  • Carola Bindt, PD Dr.

    Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics

    STUDY DIRECTOR
  • Ursula Völker, Dr.

    Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl.-Psych.

Study Record Dates

First Submitted

November 10, 2021

First Posted

December 17, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 5, 2022

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations