AnxietyTrucsDeDomNCT01392690
Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books
A study testing Dominique's Handy Tricks in people with Anxiety, run by Universite du Quebec en Outaouais at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Dominique's Handy Tricks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2000to Aug 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Dominique's Handy Tricks
- Keywords
- No condition, Primary prevention, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dominique's Handy TricksBehavioural
Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dominique's Handy Tricks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre (week 0), Post (week 10), F-up (6-months)
Secondary outcomes (1)
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.
Measured: Pre (week 0), Post (week 10), F-up (6-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startMar 2000
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite du Quebec en Outaouais
- Sponsor type
- University, hospital or other
- Investigators
- Stephane Bouchard, Ph.D., Principal investigator, Universite du Quebec en Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392690
- Sponsor's protocol ID
- RegieRegionale-07-2000-05
- Other IDs
- Les Trucs de Dominique
- Acronym
- TrucsDeDom
- Status last verified
- Jul 2011
- First submitted
- 7 Jul 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books
- ClinicalTrials.gov ID
- NCT01392690
- Acronym / sponsor ID
- TrucsDeDom / RegieRegionale-07-2000-05
- Conditions
- Anxiety
- Keywords
- No condition, Primary prevention, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universite du Quebec en OutaouaisUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list control - no intervention | No intervention | –No intervention. After the post-test they were offered the prevention program. |
| Dominique's handy tricks | Experimental | Behavioral: Dominique's Handy TricksChildren assisted to 10 workshops where they learned exercises to control their stress and anxiety. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dominique's Handy TricksChildren assisted to 10 workshops where they learned exercises to control their stress and anxiety. | Behavioural | Dominique's handy tricks |
Primary outcome
Change from pre-program on the Coping scale for children and youth
Time frame: Pre (week 0), Post (week 10), F-up (6-months)
Self-report questionnaire. Participants were assessed before implementing the prevention program (pre), after the program (week 10) and at the 6-month follow-up.
1 secondary outcome
Change from pre-program on the Childhood anxiety sensitivity index
Time frame: Pre (week 0), Post (week 10), F-up (6-months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Results publicationStéphane 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
Related trials for Anxiety
Recruiting
Internet-Based EMDR Flash Intervention for Test Anxiety in University Students
Test Anxiety
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder: A Randomized Controlled Trial
Obsessive - Compulsive Disorder, Family Accommodation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane Bouchard, Ph.D. principal investigator
Universite du Quebec en Outaouais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dominique's Handy Tricks in people with Anxiety, run by Universite du Quebec en Outaouais at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pre-program on the Coping scale for children and youth (time frame: Pre (week 0), Post (week 10), F-up (6-months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.