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Completed

NCT Number: NCT03894774

Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children (MOSES)

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)

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich

Munich, 80337, Germany

About this study

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;

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive in-patient psychotherapy treatment

Behavioral

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.

Treatment as Usual

Other

Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy

Primary outcomes

  1. Structural MRI (T1w, T2w, DTI)

    Time frame: 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)

    All structural images will be acquired in a 3 Tesla MR system using a 20- channel head-coil (Siemens, Erlangen). Data post-processing will be performed with lab-internal scripts developed for a multi-core cluster. For structural analyses of T1w, T2w and DTI data, freesurfer,FSL and workbench will be used. T1w and T2w data will be volumetrically analyzed and the results will be reported in mm3. DTI data will be processed using tbss-FSL and probtrackX-FSL. DTI will be quantified in regard of the number of white matter fiber bundles within regions-of-interest (ROIs) and from-ROI-to-ROI. The Dosenbach atlas (Dosenbach et al. 2010) and the multimodal Brainetome atlas (Fan et al. 2016) will be used for all structural analyses. It is an explorative study that follows a whole-brain approach. Changes in emotion-processing and trauma-associated brain regions such as the hippocampus,the amygdala,the orbitofrontal cortex and the insula are assumed

  2. Resting state functional MRI connectivity (rsfcMRI)

    Time frame: 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)

    EPI-sequence: fMRI will be carried out at 3 Tesla (Siemens) scanner using a 20- channel head-coil. For functional imaging, an EPI sequence with the following parameters will be used: repetition time (TR),2000 ms; echo time (TE),30 ms; flip angle (FA), 80°; spatial resolution, 3 × 3 × 3 mm3; imaging matrix, 64 × 64; field-of-view (FoV), 192 × 192 mm2; number of slices: 36; number of volumes: 200. Data post-processing will be performed with lab-internal scripts developed for a multicore cluster. For rsfcMRI analyses of freesurfer,FSL,AFNI and workbench will be used. rsfcMRI will be quantified as number of significant activated voxels (spatial extent) and connectivity strength (z-scores).Networks of interest (ICA-based): Salience network, Default Mode Network. Regions of interest (seed-based): hippocampus, the amygdala, the orbitofrontal cortex and the insula.In addition, a RS-EEG with 19 scalp electrodes is used to complement rsfcMRI,which is cortically evaluated using Brainstorm.

  3. Task-based fMRI using the International affective picture system (IAPS)

    Time frame: 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)

    For the task-based fMRI the same EPI sequence will be used as for the resting state (see outcome 2). The number of volumes: 180. Three different sets of each 45 (15 neutral, 15 negative, 15 positive rated pictures) pictures were created and randomly displayed during the scanning procedure and also afterward to control for personal affective valence and arousal with Self-Assessment Manikin (SAM).

    Data post-processing will be performed with FSL-FEAT using a block-design. Regions of interest follow the previous structural and rsfcMRI analyses ROIs: hippocampus, amygdala, orbitofrontal cortex and the insula.

Secondary outcomes

  1. Alterations in neuroendocrinological systems involved in stress regulation

    Time frame: 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)

    Oxytocin (pg/ml in Saliva) release of active stress regulation throughout relaxation using attachment interviews as stressors. Oxytocin will be analysed using radioimmunoassays in an external lab (Landgraf Riagnosis, MPI).

  2. Alterations in neuroendocrinological systems involved in stress regulation 2

    Time frame: 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)

    Cortisol (ng/mL in Saliva) release in active stress regulation throughout relaxation using attachment interviews as stressors. Cortisol will be analysed by Endocrine Laboratories, Department of Medicine IV, University Hospital, LMU Munich.

  3. Alterations in neuroendocrinological systems involved in stress regulation 3

    Time frame: 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)

    Vasopressin (pg/ml in Saliva) release of active stress regulation throughout relaxation using attachment interviews as stressors. Vasopressin will be analysed using radioimmunoassays in an external lab (Landgraf Riagnosis, MPI).

Other outcomes

  1. Behavioral Symptoms 1: Child Behaviour Checklist (CBCL)

    Time frame: 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)

    Total Problems Score: 0-28="normal", 29-37="borderline", 38-236="clinical"

  2. Behavioral Symptoms 2: Child Behaviour Checklist (CBCL)

    Time frame: 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)

    Externalizing Behaviour: 0-12="normal", 13-16="borderline", 17-66="clinical";

  3. Behavioral Symptoms 3: Child Behaviour Checklist (CBCL)

    Time frame: 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)

    Internalizing Behaviour: 0-7="normal", 8-9="borderline", 10-62="clinical";

  4. Behavioral Symptoms 4: Strength and Difficulties Questionnaire (SDQ).

    Time frame: 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)

    Total difficulties score: 0-13="normal", 14-16="borderline", 17-40="abnormal";

  5. Behavioral Symptoms 5: Strength and Difficulties Questionnaire (SDQ).

    Time frame: 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)

    hyperactivity score: 0-5="normal", 6="borderline", 7-10="abnormal"

  6. Posttraumatic Symptoms

    Time frame: 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)

    Parent Repot of Posttraumatic Symptoms (PROPS). If total testscore is greater than 16 a posttraumatic stress disorder is suspected. Total Score range: 0-60.

  7. Dissociation Symptoms

    Time frame: 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)

    Child Dissociation Scale (CDC). If total testscore is greater than 11 a dissociative disorder is suspected. Total Score range: 0-18.

  8. Depression Symptoms

    Time frame: 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)

    Depression Inventory for Children and Young People (DIKJ - Depressionsinventar für Kinder und Jugendliche) If the testscore is greater than 14 a depression is suspected. Testscore range: 0-58.

  9. Anxiety Symptoms

    Time frame: 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)

    Anxiety Questionnaire (FAS - Fragebogen für Angststörungen). If total testscore is greater than 24 a anxiety disorder is suspected. Total testscore range 0-82.

  10. Cognitive Functioning

    Time frame: 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)

    Working Memory form Wechsler Intelligence Scale for Children (WISC-IV).

    At t0/t1 a full-scale intelligence test was conducted (IQ). To minimize learning effects through rehearsal, we focused on subtests in the follow-up testing:

    • Digit Span (forward, backward)
    • Letter-Number Sequencing

    By combining both subtest scores we calculate the Working Memory Index Score. The Working Memory Index will be used to address changes in cognitive functioning.

  11. Attachment Representations

    Time frame: 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)

    Child Attachment Interview (CAI). Changes in attachment representations in a qualitative binary secure-insecure distinction and in a four category qualitative coding classification (secure, dismissing, preoccupied, disorganized).

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Collaborators

  • Max-Planck-Institute of Psychiatry

Registry information

Official study title

Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children - Clinical Pilot Study Including Multimodal Mri (MOSES)

Acronym: MOSES

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
Mar 29, 2019
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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