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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Carola Bindt, PD Dr.
  • Phone Number: +49 40 7410 54585
  • Email: bindt@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • University Medical Center Hamburg-Eppendorf

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 minutes
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"
3 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of personality functioning
Time Frame: 5 minutes
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
Level of personality functioning
Time Frame: 10 minutes
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
Social withdrawal
Time Frame: 3 minutes
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
Social withdrawal
Time Frame: 2 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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