Multimodal Music Therapy for Children With Anxiety Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062646
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
Information provided by:
University of Ulm

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Multimodal music therapy Behavioral: Community treatment as usual Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Multimodal Music Therapy for Children With Anxiety Disorders
Study Start Date : May 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Multimodal music therapy
Multimodal music therapy comprises 16 sessions single music therapy, group music therapy (max. 6 children/group), parent-child sessions, and parent counseling. The manualized treatment integrates music therapy, behavioral interventions, and family-oriented interventions.
Behavioral: Multimodal music therapy
Active Comparator: community treatment as usual Behavioral: Community treatment as usual

Primary Outcome Measures :
  1. Diagnosis of an anxiety disorder (DSM IV)

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 8-12 years
  • diagnosis of an anxiety disorder
  • IQ>80
  • informed consent and assent

Exclusion Criteria:

  • anxiety disorder is not primary focus of treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01062646

Sponsors and Collaborators
University of Ulm
Principal Investigator: Lutz Goldbeck, Ph.D. University Ulm

Responsible Party: Prof. Dr. Goldbeck, University Ulm Identifier: NCT01062646     History of Changes
Other Study ID Numbers: MUSICANXCHILD
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: May 2006

Keywords provided by University of Ulm:
music therapy
multimodal psychotherapy
anxiety disorders
pediatric anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders