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Completed

NCT Number: NCT02588079

Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

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.

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Key information

Conditions

Dental Anxiety Phobia, Specific

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dental Medicine

Stockholm, Huddinge, 14104, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based cognitive behavioral therapy

Behavioral

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Other outcomes

  1. Parental Self-Efficacy Questionnaire for Dental Anxiety

    Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)

    Measure changes in dentistry related parental self efficacy

  2. Children's Negative Cognitions in Dentistry

    Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)

    Measure changes in children's dentistry related negative thoughts.

  3. Injection Phobia Scale for Children

    Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)

    Measure changes in children's degree of anxiety related to injection

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2015
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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