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.
|
|
|
Active Comparator: 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
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
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.