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

NCT ID: NCT03894774

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-05
• Study Completion Date: 2019-08-31

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;

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive InPatient Psychotherapy Treatment Group (IG)

Intensive non-pharmaceutical inpatient 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 frame where patients live over the whole treatment (approximately a 1:1-ratio caregiver per patient is given) of 6 to 8 month treatment duration.

Group Type: EXPERIMENTAL

Intensive in-patient psychotherapy treatment

Intervention Type: 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.

Waiting Control Group (WCG)

Treatment as usual (mostly combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy).

Duration: At least 3 month to a maximum of 6 month.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy

Healthy Control Group (HCG)

Matched Pairs design to control for gender, age and handedness. HCG measurements are planned and conducted according to the exact durations of their matched inpatient pair of the IG.

Mandatory to control for effects of factors such as brain maturation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as usual

Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Max-Planck-Institute of Psychiatry

OTHER

Sponsor Role: collaborator

LMU Klinikum

OTHER

Sponsor Role: lead

Responsible Party

Karl H Brisch

Head of the Department of Pediatric Psychosomatic Medicin and Psychotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ludwig Ebeling, M.A.

Role: PRINCIPAL_INVESTIGATOR

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

Catherina Dehmel, M.sc.

Role: PRINCIPAL_INVESTIGATOR

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

Lukas Oberschneider, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Munich, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

PMID: 22101006 (View on PubMed)

Hamilton, L., Micol-Foster, V., & Muzik, M. Childhood maltreatment trauma: Relevance for adult physical and emotional health. A Review. Trauma Cases and Reviews, 1(003), 2015.

Reference Type: BACKGROUND

D'Andrea W, Ford J, Stolbach B, Spinazzola J, van der Kolk BA. Understanding interpersonal trauma in children: why we need a developmentally appropriate trauma diagnosis. Am J Orthopsychiatry. 2012 Apr;82(2):187-200. doi: 10.1111/j.1939-0025.2012.01154.x.

Reference Type: BACKGROUND

PMID: 22506521 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 20865251 (View on PubMed)

Teicher MH, Samson JA, Anderson CM, Ohashi K. The effects of childhood maltreatment on brain structure, function and connectivity. Nat Rev Neurosci. 2016 Sep 19;17(10):652-66. doi: 10.1038/nrn.2016.111.

Reference Type: BACKGROUND

PMID: 27640984 (View on PubMed)

Gold AL, Sheridan MA, Peverill M, Busso DS, Lambert HK, Alves S, Pine DS, McLaughlin KA. Childhood abuse and reduced cortical thickness in brain regions involved in emotional processing. J Child Psychol Psychiatry. 2016 Oct;57(10):1154-64. doi: 10.1111/jcpp.12630.

Reference Type: BACKGROUND

PMID: 27647051 (View on PubMed)

Gillies D, Taylor F, Gray C, O'Brien L, D'Abrew N. Psychological therapies for the treatment of post-traumatic stress disorder in children and adolescents (Review). Evid Based Child Health. 2013 May;8(3):1004-116. doi: 10.1002/ebch.1916.

Reference Type: BACKGROUND

PMID: 23877914 (View on PubMed)

Other Identifiers

MOSES

Identifier Type: -

Identifier Source: org_study_id