Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children (MOSES)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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;
    

Intervention name(s): Intensive in-patient psychotherapy treatment; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): Intensive non-pharmaceutical in-patient intervention with high degrees of individual psychotherapy (5 sessions a week, psychodynamic and specific trauma therapy), group therapy (music-, arts-, sports- and concentrative movement therapy - each one session a week) as well as an ongoing milieutherapeutic setting where patients live during the whole treatment (approximately a 1:1-Ratio caregiver per patient is given) of 6 to 8 month treatment duration.; Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy
Allocation: Non-Randomized
Intervention model: Factorial Assignment
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).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Post-Traumatic Stress Disorder; Neuroses, Posttraumatic; PTSD