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

This study has been completed.
Sponsor:
Information provided by:
Universite du Quebec en Outaouais
ClinicalTrials.gov Identifier:
NCT01392690
First received: July 7, 2011
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Anxiety
Behavioral: Dominique's Handy Tricks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books

Resource links provided by NLM:


Further study details as provided by Universite du Quebec en Outaouais:

Primary Outcome Measures:
  • Change from pre-program on the Coping scale for children and youth [ Time Frame: Pre (week 0), Post (week 10), F-up (6-months) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre (week 0), Post (week 10), F-up (6-months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 73
Study Start Date: March 2000
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Waiting list control - no intervention
No intervention. After the post-test they were offered the prevention program.
Experimental: Dominique's handy tricks
Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.
Behavioral: Dominique's Handy Tricks
Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.

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

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392690

Locations
Canada, Quebec
Universite du Quebec en Outaouais
Gatineau, Quebec, Canada, J8X 3X7
Sponsors and Collaborators
Universite du Quebec en Outaouais
Investigators
Principal Investigator: Stephane Bouchard, Ph.D. Universite du Quebec en Outaouais
  More Information

Additional Information:
No publications provided

Responsible Party: Regional Health Board of Quebec - Outaouais district, Original name of the organization: Régie Régionale de la Santé de l'Outaouais
ClinicalTrials.gov Identifier: NCT01392690     History of Changes
Other Study ID Numbers: RegieRegionale-07-2000-05, Les Trucs de Dominique
Study First Received: July 7, 2011
Last Updated: July 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Universite du Quebec en Outaouais:
No condition
Primary prevention
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014