NCT01062646

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3 anxiety

Timeline
Completed

Started May 2006

Longer than P75 for phase_3 anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
Last Updated

February 4, 2010

Status Verified

May 1, 2006

Enrollment Period

2.6 years

First QC Date

February 3, 2010

Last Update Submit

February 3, 2010

Conditions

Keywords

music therapymultimodal psychotherapychildrenanxiety disorderspediatric anxiety

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of an anxiety disorder (DSM IV)

Study Arms (2)

Multimodal music therapy

EXPERIMENTAL

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

community treatment as usual

ACTIVE COMPARATOR
Behavioral: Community treatment as usual

Interventions

Multimodal music therapy
community treatment as usual

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • anxiety disorder is not primary focus of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Lutz Goldbeck, Ph.D.

    University Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

May 1, 2006

Primary Completion

December 1, 2008

Study Completion

September 1, 2009

Last Updated

February 4, 2010

Record last verified: 2006-05