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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01392690
Other study ID # RegieRegionale-07-2000-05
Secondary ID Les Trucs de Dom
Status Completed
Phase N/A
First received July 7, 2011
Last updated July 27, 2011
Start date March 2000
Est. completion date August 2002

Study information

Verified date July 2011
Source Universite du Quebec en Outaouais
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date August 2002
Est. primary completion date August 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 12 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Dominique's Handy Tricks
Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.

Locations

Country Name City State
Canada Universite du Quebec en Outaouais Gatineau Quebec

Sponsors (1)

Lead Sponsor Collaborator
Universite du Quebec en Outaouais

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pre (week 0), Post (week 10), F-up (6-months) No
Secondary 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. Pre (week 0), Post (week 10), F-up (6-months) No
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