NCT00247754

Brief Summary

Objective:

  1. 1.To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in reducing anxiety disorder symptoms in at-risk public school children.
  2. 2.To determine whether parent education and involvement improves outcome in anxious children treated with CBT.
  3. 3.To determine the ability of school personnel in a) recognizing classroom behaviors as anxiety disordered after targeting training of observable child behaviors e.g., avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and
  4. 4.To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.
  5. 5.A CBT oriented intervention as delivered by school personnel will be superior to an attention control procedure in reducing anxiety symptoms in at-risk children.
  6. 6.Children who have parental involvement will post stronger and more enduring treatment gains.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
281

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Nov 2002

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

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

November 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
Last Updated

November 2, 2005

Status Verified

October 1, 2005

First QC Date

October 31, 2005

Last Update Submit

October 31, 2005

Conditions

Keywords

AnxietyTherapyBehaviour

Outcome Measures

Primary Outcomes (1)

  • Anxiety symptoms

Interventions

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms.
  • Anxiety disorder symptoms (identified by a score of 56 or higher on the MASC; and teacher report, and /or parent recommendation) as the primary presenting problem. An enrolled child must have at least 2 of these criterions.
  • Fluency in English.
  • Parent willingness to sign consent form and to complete required assessments.
  • Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Faculty of Education

Vancouver, British Columbia, V6T 1Z4, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersBehavior

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Lynn Miller, PhD, R.Psych.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 2, 2005

Study Start

November 1, 2002

Study Completion

June 1, 2005

Last Updated

November 2, 2005

Record last verified: 2005-10

Locations