Trials / Completed
CompletedNCT03894774
Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children (MOSES)
Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children - Clinical Pilot Study Including Multimodal Mri (MOSES)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- LMU Klinikum · Academic / Other
- Sex
- All
- Age
- 6 Years – 13 Years
- Healthy volunteers
- Accepted
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;
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Intensive in-patient psychotherapy treatment | 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. |
| OTHER | Treatment as usual | Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy |
Timeline
- Start date
- 2012-12-05
- Primary completion
- 2017-10-17
- Completion
- 2019-08-31
- First posted
- 2019-03-29
- Last updated
- 2020-02-20
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03894774. Inclusion in this directory is not an endorsement.