NCT01392690

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2000

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

2.4 years

First QC Date

July 7, 2011

Last Update Submit

July 27, 2011

Conditions

Keywords

No conditionPrimary preventionAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Change from pre-program on the Childhood anxiety sensitivity index

    Pre (week 0), Post (week 10), F-up (6-months)

Study Arms (2)

Waiting list control - no intervention

NO INTERVENTION

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

Dominique's handy tricks

EXPERIMENTAL

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

Behavioral: Dominique's Handy Tricks

Interventions

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

Dominique's handy tricks

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universite du Quebec en Outaouais

Gatineau, Quebec, J8X 3X7, Canada

Location

Related 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 sociaux de l'Outaouais, Direction de la santé publique. 2003. Library number: J506 A58 B68.2003 ISBN 2-89251-157-7

    RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Stephane Bouchard, Ph.D.

    Universite du Quebec en Outaouais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 12, 2011

Study Start

March 1, 2000

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations