Multimodal Music Therapy for Children With Anxiety Disorders

Phase 3

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Multimodal music therapy; Behavioral: Community treatment as usual

• Registration Number: NCT01062646
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2006-05
• Study Start: 2006-05
• Primary Completion: 2008-12
• Study Completion: 2009-09
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Last Update Submitted: 2010-02-03
• Study First Posted: 2010-02-04
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal music therapy	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.
community treatment as usual	Community treatment as usual	-

Primary Outcome Measures

Name	Time	Method
Diagnosis of an anxiety disorder (DSM IV)