Back to resultsInternet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety
Primary Purpose
Dental Anxiety
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety focused on measuring Dental Fear, Dental Phobia, Internet based cognitive behavioral therapy, specific phobia, children and adolescents anxiety, Self Efficacy
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
Sites / Locations
- Department of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet-based cognitive behavioral therapy
Wait list
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Picture guided behavioral approach test, child version
Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care.
Picture guided behavioral approach test, parent version
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 Outcome Measures
Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )
Measure changes in child's dentistry related self efficacy
Children's Fear Survey Schedule - Dental Subscale (child version)
Measures changes in the child's dental anxiety
Children's Fear Survey Schedule - Dental Subscale (parent version)
Measures changes in the child's dental anxiety according to one of the parents
Kiddie Sads (phobic disorders supplement)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02588079
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
Dental Fear, Dental Phobia, Internet based cognitive behavioral therapy, specific phobia, children and adolescents anxiety, Self Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based cognitive behavioral therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Picture guided behavioral approach test, child version
Description
Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care.
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Title
Picture guided behavioral approach test, parent version
Description
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.
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Secondary Outcome Measure Information:
Title
Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )
Description
Measure changes in child's dentistry related self efficacy
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Title
Children's Fear Survey Schedule - Dental Subscale (child version)
Description
Measures changes in the child's dental anxiety
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Title
Children's Fear Survey Schedule - Dental Subscale (parent version)
Description
Measures changes in the child's dental anxiety according to one of the parents
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Title
Kiddie Sads (phobic disorders supplement)
Description
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.
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Other Pre-specified Outcome Measures:
Title
Parental Self-Efficacy Questionnaire for Dental Anxiety
Description
Measure changes in dentistry related parental self efficacy
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Title
Children's Negative Cognitions in Dentistry
Description
Measure changes in children's dentistry related negative thoughts.
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
Title
Injection Phobia Scale for Children
Description
Measure changes in children's degree of anxiety related to injection
Time Frame
post treatment(12 weeks), and follow up (12 months after posttreatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shervin Shahnavaz, PhD
Organizational Affiliation
Department of Dental Medicine, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dental Medicine
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14104
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29358158
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.
Results Reference
background
PubMed Identifier
29417092
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.
Results Reference
background
PubMed Identifier
26147012
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.
Results Reference
background
Links:
URL
http://ki.se/dentmed/kbt
Description
Registration website
Learn more about this trial
Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety
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