severe mental disorder
Conditions
Interventions
Group 1: NVF intervention group
Patient population: Children and adolescents with severe mental disorders with dysfunctional behaviour such as chronic suicidal tendencies, self-harm or drug use.
The
Sponsors
Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters der Uniklinik Köln
Eligibility
Sex/Gender
All
Age
11 Years to 20 Years
Inclusion criteria
Inclusion criteria: The patient: - is at least 11 and up to 17 years old at the time of study inclusion (early and middle adolescence) or - is at least 18 and up to 20 years old at the time of study inclusion (middle and late adolescence), and - is living in a family(-like) setting (with parents or guardians) and due to a not age-appropriate psychosocial development process an independent living situation is not possible - is insured with one of the participating health insurance companies - This new form of care can be used with the following clinical pictures (at least one of the following diagnosis has been determined): • F1x • F6x • F3x • F4x (without F40.2, F41.2, F43.2) • F9x (without F93.0, F95.0) - exhibits dysfunctional (possibly self-harming) behaviour (e.g. due to drug use, suicidal tendencies, self-harm, dissocial behaviour) Functional level: - No longer has an indication for full or partial inpatient treatment and, after ? partial inpatient or ? full inpatient or ? inpatient equivalent treatment no sufficient improvement in functional level (GAF = 40) or - within 3 months after ? partial inpatient or ? full inpatient or ? inpatient-equivalent treatment will be presented again because (re-)integration and the transition to regular outpatient care has not been successful or - has no options for partial inpatient or full inpatient treatment (no services available that could be reached with reasonable effort or no free hospital place available within a reasonable period of time) and the offers of outpatient standard care over 6 months have been exhausted (GAF = 40) or - refuses (partial) inpatient treatment (GAF = 40)
Exclusion criteria
Exclusion criteria: ? IQ < 50 ? Patients for whom the following clinical conditions are in the primary focus and for whom these are the guiding principle for treatment cannot participate in the care program due to the severity and severity of the clinical condition: o F84.0, F84.1, F84.5 o F2x o F50.0 ? Patients for whom these clinical conditions (with the exception of F84.0) are not the primary focus of treatment or only existed in the past and do not exclude outpatient treatment as a comorbidity can be included after clinical consideration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychosocial functioning level (mini-ICF - blinded clinical judgement) What is the primary endpoint: The level of functioning of the study participants was chosen as the primary endpoint in order to take into account the overarching objective of the NVF, which is to enable the study participants to control and regulate themselves in the everyday outpatient setting to such an extent that they can master their developmental tasks (school, family, personality development) and avoid inpatient readmissions. Measurement method: The mini-ICF-APP and an interview guide are used to record the results. The patient-oriented effect of being able to cope with everyday life again and being able to use regular outpatient care for the further course is best reflected in the functional level across all diagnoses. Attention is paid to clinically relevant effects. Expert ratings are based on the acoustic recordings of the interviews, which are masked with regard to relevant information (person, centre, study condition and time of measurement). Measurement plan: The individual study duration per study participant is 10 months. The measurements take place according to a fixed schedule (Table 2: Examinations during the clinical trial). The initial examination serves to check the inclusion and exclusion criteria. Randomisation takes place immediately after the positive assessment of these criteria. The first measurement (T1) takes place shortly before discharge from pre-treatment The T2 measurement takes place after the end of treatment, or four months after T1 in the TAU group. For the NVF group T3 takes place 6 months after T2. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary effect measure for the study, the GAF is intended to provide further information on psychosocial functionality. In addition, the mental health of the children/adolescents is assessed across all disorders (CBCL, YSR, ILF-SCREEN, DCL-SCREEN). This is supplemented by the diagnosis-specific questionnaires and interviews in the area of affective/external disorders (DISYPS III, C-SSRS, HB-BPD-Youth-Interview, BSL-23, SITBI, DADYS). For the intervention group the current problem list and information on suicidal behaviour and self-harm are included in the individual symptomatology on a weekly basis. A mood diary is on daily via the Jay APP. The patients' quality of life (KIDSCREEN, EQ5D) is also recorded. Health economic data will be collected using CAMHSRI-DE to determine the cost-benefit analysis. Measurement plan: The individual study duration per study participant is 10 months. The measurements take place according to a fixed schedule (Table 2: Examinations during the clinical trial). The first measurement (T1) takes place shortly before discharge from pre-treatment. The patient randomised to the intervention group will undergo outreach treatment for 16 weeks. During this time interval, daily monitoring is carried out using the JAY app (Journaling App for Youth), whereby the child/adolescent gives a current assessment of their mood, self-confidence, anxiety and pressure levels and tendency to interpersonal conflicts. Once a week, the problem list is collected from the patient, the parents and the therapist. In addition, the patient is asked about suicidal behaviour and self-harm. The treatment team documents the treatment services provided each day. The T2 measurement takes place after the end of treatment or, in the TAU group, four months after T1. This is followed by individual booster appointments (1-2 times per quarter) in order to catch relapses. This treatment performance is also documented. There are no interim measurements for the control gr | — |
Countries
Germany
Contacts
Public ContactIrini Papachristou
Zentrum für klinische Studien der Uniklinik Köln
Outcome results
None listed