Multimodal Music Therapy for Children With Anxiety Disorders
| Tracking Information | |||||
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| First Received Date ICMJE | February 3, 2010 | ||||
| Last Updated Date | February 3, 2010 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Diagnosis of an anxiety disorder (DSM IV) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Multimodal Music Therapy for Children With Anxiety Disorders | ||||
| Official Title ICMJE | A Randomized Controlled Trial of Multimodal Music Therapy for Children With Anxiety Disorders | ||||
| Brief Summary | Multimodal music therapy (MT) for children ages 8 to 12 years with anxiety disorders is compared to community treatment as usual (TAU). 36 children were randomized either to MT or to TAU. Primary outcome is presence of an anxiety disorder at the end of treatment. Secondary outcomes are self- and parent-/teacher reported anxiety, co-morbid psychological symptoms, and quality of life. Stability of outcome is assessed six months after the end of treatment. |
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| Detailed Description | Patients were enrolled in a community clinic and in an outpatient clinic for child and adolescent psychiatry/psychotherapy. Inclusion criteria: diagnosis of an anxiety disorder (separation anxiety disorder, general anxiety disorder, social phobia, specific phobia, or other anxiety disorder); age 8-12; no medication or stable medication during treatment; IQ>80; informed consent of caregivers and informed assent of patients. Outcome measures. Kiddie-SADS; STAIC-C, SPAIC, CDI; SDQ teacher report; CBCL 4-18; ILK quality of life inventory. Assessment time points: pre-intervention; post-intervention; 6-months follow-up. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Anxiety | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 36 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01062646 | ||||
| Other Study ID Numbers ICMJE | MUSICANXCHILD | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Dr. Goldbeck, University Ulm | ||||
| Study Sponsor ICMJE | University of Ulm | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Ulm | ||||
| Verification Date | May 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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