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Multimodal Music Therapy for Children With Anxiety Disorders

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Multimodal music therapy
Community treatment as usual
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring music therapy, multimodal psychotherapy, children, anxiety disorders, pediatric anxiety

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Multimodal music therapy

    community treatment as usual

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Diagnosis of an anxiety disorder (DSM IV)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2010
    Last Updated
    February 3, 2010
    Sponsor
    University of Ulm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01062646
    Brief Title
    Multimodal Music Therapy for Children With Anxiety Disorders
    Official Title
    A Randomized Controlled Trial of Multimodal Music Therapy for Children With Anxiety Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    September 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Ulm

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety
    Keywords
    music therapy, multimodal psychotherapy, children, anxiety disorders, pediatric anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multimodal music therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    community treatment as usual
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multimodal music therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Community treatment as usual
    Primary Outcome Measure Information:
    Title
    Diagnosis of an anxiety disorder (DSM IV)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lutz Goldbeck, Ph.D.
    Organizational Affiliation
    University Ulm
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Multimodal Music Therapy for Children With Anxiety Disorders

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