Clinical trial NCT03894774: Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children (MOSES)
Official title: Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children - Clinical Pilot Study Including Multimodal Mri (MOSES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Chronic Post-Traumatic Stress Disorder
Neuroses, Posttraumatic
PTSD
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: Max-Planck-Institute of Psychiatry
First posted: 2019-03-29
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study was conducted in the following randomized waiting control design:

After being included in the study at time T0 the children stay in Treatment-As-Usual (TAU) for at least three months and are then randomly assigned to the Intensive Inpatient Psychotherapy Treatment Group (IG) or the Waiting Control Group (WCG) after this TAU time period (This period is considered necessary and sufficient in order to reliably estimate possible trends of changes in the brain). The children in the WCG stay in TAU and are assigned to the IG as soon as a treatment place is available. The waiting period will be included in the analysis as a confounder. The third group is a Healthy Control Group (HCG) of matched pairs (matched for gender, age and handedness).
Primary purpose: TREATMENT

Brief summary: Evaluation of longitudinal treatment effects applying an intensive psychotherapeutic intervention for inpatients (age of participants: 6-13 years) with a multi-method-approach to address the complex nature of severe childhood trauma. (Chronic Post-Traumatic Stress Disorder)

Detailed description: Severe adversity and trauma in early childhood have been associated with a highly increased risk for a variety of psychiatric disorders, lasting into adulthood. This increased risk is accompanied by a set of biological changes ranging from changes in cortical thickness to endocrinological changes. At a behavioral level, children with complex PTSD (developmental trauma disorder) show severe and long-lasting negative effects. Such children exhibit a wide range of symptoms: affect dysregulation, attention difficulties, impairment in interpersonal relationships, aggressive and dissociative behaviour, disturbances of cognition. Corresponding alterations in neural networking and brain development are well studied. Although evidence-based treatment approaches for children with non-complex PTSD exist, complex-traumatized children have no well-evaluated treatments. Furthermore, early intervention can prevent the chronification and exacerbation of symptoms and promote social adaptation and participation.The following topics will be addressed: (1) brain development (Multimodal MRI (mMRI) including anatomical (T1-MPRAGE, T2-FLAIR, DTI-Diffusion Tensor Imaging) and functional MRI measurements (resting-state functional MRI, task fMRI (presenting affective pictures according to the International Affective Picture System, IAPS), EEG); (2) alterations in neuroendocrinological systems involved in stress regulation (Cortisol, Oxytocin, Vasopressin); (3) behavioral symptoms; (4) cognitive functioning; (5) attachment representations of children and their primary caregivers;

Eligibility criteria: Inclusion Criteria:

* Severe early traumatization with experiences of violence, neglect, abuse and chronic symptoms related to complex PTSD.

Exclusion Criteria:

* Autism spectrum disorder
* Addiction disorder
* Mental disability (IQ \< 85)
* Endangerment to themselves or others

Primary outcomes:
measure: Structural MRI (T1w, T2w, DTI)
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Resting state functional MRI connectivity (rsfcMRI)
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Task-based fMRI using the International affective picture system (IAPS)
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Secondary outcomes:
measure: Alterations in neuroendocrinological systems involved in stress regulation
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Alterations in neuroendocrinological systems involved in stress regulation 2
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Alterations in neuroendocrinological systems involved in stress regulation 3
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Other outcomes:
measure: Behavioral Symptoms 1: Child Behaviour Checklist (CBCL)
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Behavioral Symptoms 2: Child Behaviour Checklist (CBCL)
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Behavioral Symptoms 3: Child Behaviour Checklist (CBCL)
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Behavioral Symptoms 4: Strength and Difficulties Questionnaire (SDQ).
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Behavioral Symptoms 5: Strength and Difficulties Questionnaire (SDQ).
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Posttraumatic Symptoms
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Dissociation Symptoms
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Depression Symptoms
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Anxiety Symptoms
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Cognitive Functioning
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
measure: Attachment Representations
timeFrame: longitudinal (4 measurements, t0: at least 3 month before treatment, t1: at admission to treatment, t2: at discharge (average of 8 month), t3: 6 month post treatment)
Locations:
city: Munich
country: Germany
facility: Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
Study officials:
affiliation: Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
name: Ludwig Ebeling, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
name: Catherina Dehmel, M.sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich
name: Lukas Oberschneider, MD
role: PRINCIPAL_INVESTIGATOR
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