Multimodal Music Therapy for Children With Anxiety Disorders

NCT ID: NCT01062646

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-09-30

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Multimodal music therapy

Intervention Type: BEHAVIORAL

community treatment as usual

Group Type: ACTIVE_COMPARATOR

Community treatment as usual

Intervention Type: BEHAVIORAL

Interventions

Multimodal music therapy

Intervention Type: BEHAVIORAL

Community treatment as usual

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

University Ulm

Principal Investigators

Lutz Goldbeck, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Ulm

Other Identifiers

MUSICANXCHILD

Identifier Type: -

Identifier Source: org_study_id