Personality DisordersCAPPSNCT05162287
Child and Adolescent Psychiatric Personality Structure
An observational study of Personality Disorders and Social Withdrawal of Childhood or Adolescence, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Personality Disorders, Social Withdrawal of Childhood or Adolescence, Psychosocial Impairment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 5 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Personality Disorders, Social Withdrawal of Childhood or Adolescence, Psychosocial Impairment
- Keywords
- acute adolescent psychiatric units
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
Measured: 3 minutes
Secondary outcomes (4)
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.
Measured: 5 minutes
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.
Measured: 10 minutes
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.
Measured: 3 minutes
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Personality DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Boettcher, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Johannes Boettcher, M.Sc., Principal investigator, Department of Child and Adolescent Psychiatry, Psychotherapy and PsychosomaticsCarola Bindt, PD Dr., Study director, Department of Child and Adolescent Psychiatry, Psychotherapy and PsychosomaticsUrsula Völker, Dr., Principal investigator, Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162287
- Sponsor's protocol ID
- 2021-100618-BO-FF
- Acronym
- CAPPS
- Status last verified
- Jul 2023
- First submitted
- 10 Nov 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided if there will be a plan to make IPD available.
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.
PubMed 27002640Hall 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.
PubMed 23896764Tharayil 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.
PubMed 23946699Yuan JM. HoNOSCA in an adolescent psychiatric inpatient unit: an exploration of outcome measures. Psychiatr Danub. 2015 Sep;27 Suppl 1:S357-63.
PubMed 26417796Schmeck, 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.
PubMed 30907712Fonagy 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.
PubMed 26271454Chanen 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.
PubMed 28498598
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Distress, Levels of Personality Functioning, and Social Withdrawal in a Child and Adolescent Psychiatric Acute Inpatient Population
- ClinicalTrials.gov ID
- NCT05162287
- Acronym / sponsor ID
- CAPPS / 2021-100618-BO-FF
- Conditions
- Personality Disorders, Social Withdrawal of Childhood or Adolescence, Psychosocial Impairment
- Keywords
- acute adolescent psychiatric units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychosocial distress
Time frame: 7 minutes
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.
Psychosocial distress
Time frame: 3 minutes
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"
4 secondary outcomes
Level of personality functioning
Time frame: 5 minutes
Level of personality functioning
Time frame: 10 minutes
Social withdrawal
Time frame: 3 minutes
Social withdrawal
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- BackgroundRemschmidt, H., Schmidt, M. H., & Poustka, F. (2017). Multiaxiales Klassifikationsschema für psychische Störungen des Kindes- und Jugendalters nach ICD-10 (7th ed.). Hogrefe AG.
- Background: PubMed 27002640Kronstrom 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.
- Background: PubMed 23896764Hall 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.
- Background: PubMed 23946699Tharayil 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.
- Background: PubMed 26417796Yuan JM. HoNOSCA in an adolescent psychiatric inpatient unit: an exploration of outcome measures. Psychiatr Danub. 2015 Sep;27 Suppl 1:S357-63.
- BackgroundSchmeck, 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: PubMed 30907712Goth 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.
- Background: PubMed 26271454Fonagy 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.
- Background: PubMed 28498598Chanen 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.
- Individual participant dataSharing planned: Undecided. It is not yet decided if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Boettcher, M.Sc. principal investigator
Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
Carola Bindt, PD Dr. study director
Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
Ursula Völker, Dr. principal investigator
Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personality Disorders and Social Withdrawal of Childhood or Adolescence, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial distress (time frame: 7 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162287, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.