Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

Overview

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.

Full Title of Study: “Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

Interventions

  • Behavioral: Internet-based cognitive behavioral therapy

Arms, Groups and Cohorts

  • Experimental: Internet-based cognitive behavioral therapy
    • The treatment program consists of 12 modules that are offered during 12 weeks on Internet. Modules consist of parental education, psycho-education for the children, exposure, cognitive restructuring and home exercises. A psychologist guides parents and children through the treatment with continuous contact using the message function on the Internet platform that is used.
  • No Intervention: Wait list
    • Participants are not offered any active controlled psychological interventions but have free access to dental health services, which could involve exposure and other behavioral strategies applied by dental staff.

Clinical Trial Outcome Measures

Primary Measures

  • Picture guided behavioral approach test, child version
    • Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
    • Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care.
  • Picture guided behavioral approach test, parent version
    • Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
    • Measures changes in the child´s ability to manage dental situations according to a parent. The test shows 17 realistic images from the dental care.

Secondary Measures

  • Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )
    • Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
    • Measure changes in child’s dentistry related self efficacy
  • Children’s Fear Survey Schedule – Dental Subscale (child version)
    • Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
    • Measures changes in the child’s dental anxiety
  • Children’s Fear Survey Schedule – Dental Subscale (parent version)
    • Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
    • Measures changes in the child’s dental anxiety according to one of the parents
  • Kiddie Sads (phobic disorders supplement)
    • Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
    • The phobic disorders supplement of Kiddie Sads diagnostic interview (Version 1.0 of October 1996) is performed by a psychologist through a telephone interview. The outcome is used to investigate whether the participant fulfill the diagnostic criteria for dentistry related specific phobia according to DSM 4.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shervin Shahnavaz, Psychologist – Karolinska Institutet
  • Overall Official(s)
    • Shervin Shahnavaz, PhD, Principal Investigator, Department of Dental Medicine, Karolinska Institutet
  • Overall Contact(s)
    • Shervin Shahnavaz, PhD, +46-722154769, shervin.shahnavaz@ki.se

References

Shahnavaz S, Hedman-Lagerlöf E, Hasselblad T, Reuterskiöld L, Kaldo V, Dahllöf 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.

Shahnavaz S, Hedman E, Grindefjord M, Reuterskiöld L, Dahllöf 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.

Shahnavaz S, Rutley S, Larsson K, Dahllöf 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.

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