Multimodal Music Therapy for Children With Anxiety Disorders

Anxiety Clinical Trial

Official title:

A Randomized Controlled Trial of Multimodal Music Therapy for Children With Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062646
• Other study ID #: MUSICANXCHILD
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2010
• Last updated: February 3, 2010
• Start date: May 2006
• Est. completion date: September 2009

Study information

• Verified date: May 2006
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Multimodal music therapy

• Community treatment as usual

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of an anxiety disorder (DSM IV)