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Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books (TrucsDeDom)

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dominique's Handy Tricks
Sponsored by
Universite du Quebec en Outaouais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring No condition, Primary prevention, Anxiety

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Recruitment for this study was open to every child in the school and was carried out with the help of staff from schools in Gatineau and Saint-André Avelin, Quebec.
  • A total of 73 children aged between 9 and 12 years of age were screened.

Exclusion criteria:

Since the program does not target a clinical population, the following exclusion criteria were used:

  • (1) a global score > 75 on the Child Behavior Checklist;
  • (2) a score > 60 on the Screen for Child Anxiety Related Emotional Disorders (SCARED, child version);
  • (3) outliers on outcome measures administered at pre-test; and
  • (4) children who did not show up for the first workshop. The final enrolled study sample consisted of 59 children.

Sites / Locations

  • Universite du Quebec en Outaouais

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waiting list control - no intervention

Dominique's handy tricks

Arm Description

No intervention. After the post-test they were offered the prevention program.

Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.

Outcomes

Primary Outcome Measures

Change from pre-program on the Coping scale for children and youth
Self-report questionnaire. Participants were assessed before implementing the prevention program (pre), after the program (week 10) and at the 6-month follow-up.

Secondary Outcome Measures

Change from pre-program on the Childhood anxiety sensitivity index
Self-report questionnaire. Self-report questionnaire. Participants were assessed before implementing the prevention program (pre), after the program (week 10) and at the 6-month follow-up.

Full Information

First Posted
July 7, 2011
Last Updated
July 27, 2011
Sponsor
Universite du Quebec en Outaouais
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1. Study Identification

Unique Protocol Identification Number
NCT01392690
Brief Title
Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books
Acronym
TrucsDeDom
Official Title
Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universite du Quebec en Outaouais

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the impact of a primary prevention program for anxiety disorders. This study was completed between 2000 and 2002, with the final report transmitted to the Quebec ministry of health in 2003.
Detailed Description
This study reports the results of a study evaluating a book-supported prevention program "Dominique's Handy Tricks" for anxiety disorders in children aged 9 to 12 years of age. This cognitive-behavioural program is delivered using a combination of story-based books and workshop sessions. The originality of the program comes from the use of story books that were not developed for anxiety management specifically. Every session is based on a story describing characters facing common stressors in childhood and how they managed to cope with their daily problems. In our randomized control trial with 46 children, participation in the program lead to a significant improvement in coping skills, self-efficacy, anxiety sensitivity, signs of anxiety and phobic avoidance. The theoretical and practical elements underlying the delivery of this primary prevention programs are described. It is suggested that such an approach, without any labelling specific to anxiety disorders, can be useful in universal primary prevention programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
No condition, Primary prevention, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waiting list control - no intervention
Arm Type
No Intervention
Arm Description
No intervention. After the post-test they were offered the prevention program.
Arm Title
Dominique's handy tricks
Arm Type
Experimental
Arm Description
Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Dominique's Handy Tricks
Intervention Description
Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.
Primary Outcome Measure Information:
Title
Change from pre-program on the Coping scale for children and youth
Description
Self-report questionnaire. Participants were assessed before implementing the prevention program (pre), after the program (week 10) and at the 6-month follow-up.
Time Frame
Pre (week 0), Post (week 10), F-up (6-months)
Secondary Outcome Measure Information:
Title
Change from pre-program on the Childhood anxiety sensitivity index
Description
Self-report questionnaire. Self-report questionnaire. Participants were assessed before implementing the prevention program (pre), after the program (week 10) and at the 6-month follow-up.
Time Frame
Pre (week 0), Post (week 10), F-up (6-months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Recruitment for this study was open to every child in the school and was carried out with the help of staff from schools in Gatineau and Saint-André Avelin, Quebec. A total of 73 children aged between 9 and 12 years of age were screened. Exclusion criteria: Since the program does not target a clinical population, the following exclusion criteria were used: (1) a global score > 75 on the Child Behavior Checklist; (2) a score > 60 on the Screen for Child Anxiety Related Emotional Disorders (SCARED, child version); (3) outliers on outcome measures administered at pre-test; and (4) children who did not show up for the first workshop. The final enrolled study sample consisted of 59 children.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Bouchard, Ph.D.
Organizational Affiliation
Universite du Quebec en Outaouais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universite du Quebec en Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8X 3X7
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
Stéphane Bouchard, Jean Gervais, Nadia Gagnier. Évaluation d'un programme de prévention primaire des troubles d'anxiété pour les enfants de 9 à 12 ans : les trucs de Dominique. Rapport de recherche présenté à la Régie régionale de la santé et des services sociaux de l'Outaouais, Direction de la santé publique. 2003. Library number: J506 A58 B68.2003 ISBN 2-89251-157-7
Results Reference
result

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Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books

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