Multimodal Music Therapy for Children With Anxiety Disorders

February 3, 2010 updated by: University of Ulm

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Diagnosis of an anxiety disorder (DSM IV)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Lutz Goldbeck, Ph.D., University Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSICANXCHILD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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