Clinical trial NCT01392690: Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books
Official title: Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: No condition
Primary prevention
Anxiety
Lead sponsor: Universite du Quebec en Outaouais
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 73
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change from pre-program on the Coping scale for children and youth
timeFrame: Pre (week 0), Post (week 10), F-up (6-months)
Secondary outcomes:
measure: Change from pre-program on the Childhood anxiety sensitivity index
timeFrame: Pre (week 0), Post (week 10), F-up (6-months)
Other outcomes:
Locations:
city: Gatineau
country: Canada
facility: Universite du Quebec en Outaouais
state: Quebec
Study officials:
affiliation: Universite du Quebec en Outaouais
name: Stephane Bouchard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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