1) children aged 6-11 years with a verified history of maltreatment or abuse who additionally show a psychiatric disorder according to ICD-10 axis 1
Conditions
Interventions
Group 1: Experimental intervention / index test:
Trauma-focused cognitive behavioral therapy (TF-CBT) for SP1, 4.
Duration of treatment TF-CBT: 16 sessions with 90min each (45min with the child, 45mi
12 weeks for KIDNET (SP2).
Follow-up per subject / patient: Baseline at T0 (pre intervention), post intervention at T1 (6 months after T0), follow-up at 6, 12, 18 months after T1.
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
3 Years to 11 Years
Inclusion criteria
Inclusion criteria: SP1: 1) for the children of the existing cohort of the Berlin Longitudinal Child Study and for newly recruited children aged 6-11 years with a history of maltreatment: the presence of a psychiatric disorder according to ICD-10 axis 1, as diagnosed by a structured clinical interview with the caregiver; for the new group of children aged 3-5 years: the presence of maltreatment according to the maltreatment classification system with severity scores =2. 2) timely availability for the participation in weekly therapy sessions over the course of 16 weeks; 3) sufficient German language skills 4) caretaker availability for TF-CBT 5) sufficiently stable psychosocial situation TP2: 1) presence of PTSD according to ICD-10 (defined by clinical interview) or PTSD or partial PTSD according to DSM-5, defined by the UCLA PTSD Reaction Index. Partial PTSD is defined by the presence of a traumatic event, the presence of 2 out of 4 symptom clusters and the presence of clinically significant distress or impairment in functioning. 2) timely availability for the participation in weekly therapy sessions over the course of 12 weeks; 3) sufficiently stable psychosocial situation SP4: 1) exposure to moderate ELS, including child maltreatment as defined by the maltreatment classification system with a severity score =2 or including prolonged separation from a parent, severe life-threatening illness in child, siblings, or parents, war-related trauma, natural disasters, and accidents, as assessed using structured interviews; 2) timely availability for the participation in weekly therapy sessions over the course of 16 weeks; 3) sufficient German language skills 4) caretaker availability for TF-CBT 5) sufficiently stable psychosocial situation
Exclusion criteria
Exclusion criteria: TP1, TP2 und TP4: 1) child currently in psychotherapy; 2) acute severe psychiatric disorder (e.g., psychosis); 3) acute and severe somatic disorder; 4) acute suicidality; 5) severe or life-threatening self-injuries during the last 6 months; 6) presence of a pervasive developmental disorder (e.g. autism); 7) mental retardation (IQ < 70); 8) further assessment needed due to complexity of symptoms; 9) indication for inpatient treatment or other further care/intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: Primary endpoint is child mental health, defined by symptom scores and by the presence of a psychiatric disorder according to ICD-10 and according to the level of clinical symptoms. Child mental health as primary endpoint will be assessed by a semistructured clinical interview (K-Sads-PL) and by validated questionnaires in child self report if child age is > 6 years and in parent report (SCARED, CES-DC, UCLA-RI, CBCL). Child mental health will be assessed at all time points of measurement, i.e., baseline pre intervention, T1 post intervention, 6-, 12-, and 18 months post intervention. In addition, we will test whether changes in embedding trajectories predict primary efficacy outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint(s): Health-related quality of life of the child as measured by KIDSCREEN-10, a validated questionnaire (child report if child age >= 6 years, parent report in all cases). Secondary endpoints are the presence of medical diagnoses and neurocognitive function assessed 6, 12, 18 and 24 months after baseline (SP1-2, 4) and the developmental status of the child (nonverbal and verbal intelligence, motor developmental skills), assessed 12 and 24 months after the baseline assessment (SP1-2, 4). Further secondary endpoints related to child physical health are anthropometric measures (height, weight), waist and hip circumference, skin fold thickness (triceps, biceps, subscapular skin folds). In TP4, body fat will be assessed. In addition, biological embedding markers including psychobiological, neural and molecular genetic markers (SP5-7) will be defined as secondary endpoints. Psychobiological markers (SP5) will be collected 12 and 24 months after baseline; neuronal (SP6) and molecular genetic markers (SP7) will be collected 24 months after baseline. | — |
Countries
Germany
Contacts
Public ContactChristine Heim
Charité Universitätsmedizin Berlin, Institut für Medizinische Psychologie
Outcome results
None listed