Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.

Official Title
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Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

Conditions
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Dental Anxiety

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient and parents agree to participate in the research project A primary diagnosis of specific phobia (dental anxiety or needle phobia) can be established according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition. Exclusion Criteria: The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis The patient undergoing psychiatric examination and/or psychotherapy The patient has no dental treatment needs or the dental treatment needs are of an emergency nature.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br> | Behavioral: Cognitive Behavioral Therapy<br>* The treatment group is offered cognitive behavior therapy(CBT) by psychologists/psychotherapists. CBT is offered according to a treatment manual and consists of 10- sessions during 12-15 weeks.<br>|
| Active Comparator: Treatment as usual<br> | Behavioral: Treatment As Usual<br>* Treatment as usual consist of strategies such as habituation, tell-show-do, premedication with midazolam, nitrous oxide sedation and general anesthesia. All offered by dentists and dental hygienist and/or dental assistants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dental anxiety | Both child and parental versions of Children's Fear Survey Schedule - Dental Subscale will be administered. | 3 months and 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Behavioral Avoidance | Behavioral Avoidance Test consists of 18 dental situations. The patient is exposed to a situation at a time. Patients receive 1 point for every step he / she manage. The test is stopped when the patient does not want to go further. | 3 months and 12 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Fear, Dental Phobia, Cognitive Behavior Therapy, Specific Phobia, Children and Adolescents anxiety, Self Efficacy