Clinical trial NCT02588079: Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety
Official title: Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Dental Fear
Dental Phobia
Internet based cognitive behavioral therapy
specific phobia
children and adolescents anxiety
Self Efficacy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome measures compared with patients in control group.


Eligibility criteria: Inclusion Criteria:

* The participant is between 8-15 years of age
* The patient and parents agree to participate in the research project
* A diagnosis of specific phobia (dental anxiety or intraoral needle phobia) can be established by a psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition. The internet parent version of Development and Well-Being Assessment (Dawba) and Kiddie Sads (phobic disorders supplement) are used.
* The patient and parents have sufficient language skills in Swedish to manage the treatment and questionnaires
* Have regularly access to computer and the internet
* Have the time, the possibility and motivation to work and practice with ICBT 3 hours each week in 12 weeks
* Parents agree to at least book three visits at the dentist during the 12 weeks treatment
* Parents agree to exposure for intraoral injection at the dentist even if the child does not need dental treatment but suffers from injection phobia

Exclusion Criteria:

* Full points on both child and parent versions of the picture guided behavioral approach test. A maximum score of 17 means that both the child and the parent assess that the child can manage the most challenging situations in dentistry
* A score of 31 or less on both children and parent version of CFSS-DS and do not fulfill criteria for intra-oral injection phobia
* Already have or according to DAWBA and/or telephone interview by psychologist likely to fulfill criteria for a neurodevelopmental disorder diagnosis
* Other psychiatric disorders such as severe depression, eating disorder or self harm behavior that need treatment prior to dentistry related specific phobia
* The participant is undergoing or has planned psychiatric/ psychological examination
* The participant has current/planed psychological treatments
* Stressful life experiences during the past 12 months, such as divorce in the family, somatic illness that parent or the psychologist see as an obstacle in the treatment
* Have received cognitive behavioral treatment for dental anxiety or needle phobia during the past three years

Primary outcomes:
measure: Picture guided behavioral approach test, child version
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
measure: Picture guided behavioral approach test, parent version
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Secondary outcomes:
measure: Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
measure: Children's Fear Survey Schedule - Dental Subscale (child version)
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
measure: Children's Fear Survey Schedule - Dental Subscale (parent version)
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
measure: Kiddie Sads (phobic disorders supplement)
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Other outcomes:
measure: Parental Self-Efficacy Questionnaire for Dental Anxiety
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
measure: Children's Negative Cognitions in Dentistry
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
measure: Injection Phobia Scale for Children
timeFrame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Locations:
city: Stockholm
country: Sweden
facility: Department of Dental Medicine
state: Huddinge
Study officials:
affiliation: Department of Dental Medicine, Karolinska Institutet
name: Shervin Shahnavaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahnavaz S, Hedman-Lagerlof E, Hasselblad T, Reuterskiold L, Kaldo V, Dahllof G. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental Anxiety: Open Trial. J Med Internet Res. 2018 Jan 22;20(1):e12. doi: 10.2196/jmir.7803.
citation: Shahnavaz S, Hedman E, Grindefjord M, Reuterskiold L, Dahllof G. Cognitive Behavioral Therapy for Children with Dental Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Oct;1(3):234-243. doi: 10.1177/2380084416661473. Epub 2016 Aug 15.
citation: Shahnavaz S, Rutley S, Larsson K, Dahllof G. Children and parents' experiences of cognitive behavioral therapy for dental anxiety--a qualitative study. Int J Paediatr Dent. 2015 Sep;25(5):317-26. doi: 10.1111/ipd.12181. Epub 2015 Jul 4.