Study of Anxiety Free Experiences at the Dentist (SAFE-D)
One Session Treatment for Dental Phobia in an Underserved Population
The goal of this clinical trial is to compare two treatments for dental phobia in children and adolescents: One-Session Treatment for Dental Phobia (OSTD) and psychoeducation plus relaxation training (RELAX).
The main questions this study aims to answer are:
- Is one intervention more effective in reducing the severity of dental phobia 6 months after treatment?
- Are improvements in dental fear and anxiety maintained 12 months after treatment?
- How do changes in fear-related learning and beliefs contribute to treatment outcomes?
- How acceptable and practical are these treatments for youth, their parents, and the professionals delivering the treatments?
Researchers will enroll approximately 160 youth with dental phobia and randomly assign them to one of two treatment groups. Participants will receive either OSTD or RELAX.
Participants will:
- Complete an initial assessment of their dental fear and anxiety.
- Participate in their assigned treatment.
- Complete assessments 1 week, 6 months, and 12 months after treatment to evaluate changes in dental fear, anxiety, and related beliefs and behaviors.
Researchers will compare the two groups to determine which treatment is more effective in reducing dental phobia, whether improvements last over time, and how changes in fear-related learning may contribute to treatment outcomes.
Study Overview
Status
Detailed Description
The study will examine inhibitory learning as a potential mechanism underlying improvements in dental phobia following One-Session Treatment for Dental Phobia (OSTD) compared with psychoeducation and relaxation training (RELAX). Inhibitory learning involves developing new associations that reduce the influence of previously learned fear responses. The study will investigate whether changes in implicit associations with dental-related stimuli and beliefs about potential harm help explain treatment-related improvements in dental phobia.
Exploratory analyses will examine potential predictors and moderators of treatment outcomes at 6 and 12 months post-treatment. Variables of interest include coping efficacy, habituation, fear activation, acculturation, outcome expectancy, fear of pain, cognitive vulnerability, comorbidity, and distress tolerance. Multiple regression models will evaluate associations between these variables and treatment outcomes, including dental phobia severity, dental anxiety symptoms, individualized treatment goal attainment, and dental cleaning appointment attendance. Selected analyses will be restricted to participants receiving OSTD when the predictor is specific to that intervention. Additional analyses will examine whether baseline characteristics moderate differences in treatment outcomes between OSTD and RELAX.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SAFE-D Research Team Member
- Phone Number: 956-665-3500
- Email: safe-d@utrgv.edu
Study Locations
-
-
Texas
-
Brownsville, Texas, United States, 78520
- Not yet recruiting
- University of Texas Rio Grande Valley
-
Contact:
- SAFE-D Study Team Member
- Phone Number: 956-665-3500
- Email: safe-d@utrgv.edu
-
Edinburg, Texas, United States, 78539
- Recruiting
- University of Texas Rio Grande Valley
-
Contact:
- SAFE-D Study Team Member
- Phone Number: 956-665-3500
- Email: safe-d@utrgv.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all the following criteria:
- Subject and one parent/LAR must be willing and able to give informed assent/consent for participation in the study.
- Subject and one parent/LAR must be willing and able to comply with all study procedures for the duration of the study, including randomization to treatment condition and interventionist.
- Subject must be between 7 and 16 years of age.
- Subject must meet DSM 5 criteria for a specific phobia, blood- injection -injury type with dental stimuli as the focus of the phobia.
- Subject and parent/LAR must be able to read, write, and converse in English or Spanish.
Exclusion Criteria:
An individual who meets any of the following criteria at baseline will be excluded from participating in this study:
If the parent-reports:
- Subject or first degree relative participated in the pilot study (UG3DE031247).
- Subject has active suicidal ideation, psychotic disorder, intellectual disability (as indicated by school placement), or severe autism spectrum disorder.
- Subject's dental fears are limited to fear of injections or sight of blood.
- Subject resides in the same household as another individual already participating in current study.
- Subject is a first degree relative of another individual already participating in current study.
- Subject has received a trial of exposure therapy or relaxation treatment for dental phobia in the past year.
- Subject is currently taking anxiolytic medication, and the dose or medication is likely to change between Baseline Assessment and Six-Month Post Treatment Assessment.
- Any other significant disease or disorder that would place the subject at risk because of participation in the study or preclude the subject's full compliance with or completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OSTD
OSTD is a cognitive behavioral treatment with the main component of the treatment being massed exposure exercises guided by an inhibitory learning framework. |
OSTD is a single-session behavioral intervention designed to reduce dental phobia in children and adolescents. The intervention uses individualized, graduated exposure to feared dental situations and procedures. Exposure activities are guided by a participant-specific fear hierarchy and cognitive-behavioral assessment developed before treatment. During the treatment session, participants engage in exposure exercises intended to help them confront feared dental situations and develop new learning about anticipated negative outcomes. |
|
Active Comparator: RELAX
RELAX is a psychoeducational intervention paired with progressive muscle relaxation. |
RELAX is a single-session behavioral comparison intervention consisting of psychoeducation and relaxation training for children and adolescents with dental phobia. The intervention includes information about dental-related fear and anxiety and instruction in relaxation strategies, including progressive muscle relaxation. Participants receive guided relaxation training intended to support the management of anxiety associated with dental situations. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dental Phobia Severity From Baseline to 6 Months Post-Treatment
Time Frame: 6 months post-treatment
|
Dental phobia severity will be assessed using the dental phobia module of the Anxiety Disorders Interview Schedule for Children. Information obtained from parent and child interviews will be used to establish a consensus Clinician Severity Rating (CSR). The primary outcome is the consensus CSR at 6 months post-treatment. Score range is 0 to 8, lower scores indicate less severe dental phobia. Treatment group differences will be evaluated using regression analysis adjusting for baseline CSR and prespecified covariates. |
6 months post-treatment
|
|
Change in Dental Phobia Severity From Baseline to 12 Months Post-Treatment
Time Frame: 12 months post-treatment
|
Dental phobia severity will be assessed using the dental phobia module of the Anxiety Disorders Interview Schedule for Children. Parent and child interview information will be used to establish a consensus Clinician Severity Rating (CSR). Score range is 0 to 8, lower scores indicate less severe dental phobia. The 12-month consensus CSR will be compared between treatment groups, adjusting for baseline CSR and prespecified covariates. |
12 months post-treatment
|
|
Change in Dental Anxiety Symptoms From Baseline to 12 Months Post-Treatment
Time Frame: 1 week, 6 months, and 12 months post-treatment
|
Dental anxiety symptoms will be assessed using the Modified Child Dental Anxiety Scale (MCDAS) and a modified parent version (MDAS-P) administered to children and parents. Scores will be used to evaluate dental anxiety at 1 week, 6 months, and 12 months post-treatment. Treatment group differences will be evaluated at each follow-up assessment using regression models adjusting for baseline dental anxiety and prespecified covariates. Higher scores indicate greater dental anxiety. |
1 week, 6 months, and 12 months post-treatment
|
|
Attainment of Personalized Treatment Goal at 6 Months and 12 Months Post Treatment
Time Frame: 6 months and 12 months post-treatment
|
Treatment goal attainment will be evaluated using a personalized treatment goal identified by the participant's family. Goal attainment will be classified into three ordered categories: no attainment, partial attainment, and full attainment. Treatment group differences will be evaluated using ordinal regression models. |
6 months and 12 months post-treatment
|
|
Attendance at Recommended Dental Cleaning Appointment
Time Frame: 6 months and 12 months post-treatment
|
Compliance with dental health treatment recommendations will be assessed by determining whether the participant attended a recommended dental cleaning appointment. Attendance will be recorded as a binary outcome (attended or did not attend). Treatment group differences will be evaluated at the 6-month and 12-month follow-up assessments. |
6 months and 12 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implicit Associations With Dental Stimuli Assessed by the Affect Misattribution Procedure (AMP)
Time Frame: Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment
|
Implicit associations with dental-related stimuli will be assessed using the Affect Misattribution Procedure (AMP). AMP performance will be examined as an indicator of inhibitory learning and evaluated as a potential mediator of treatment outcomes. The measure will be assessed before treatment and at subsequent assessment points to examine treatment-related changes in automatic affective responses to dental stimuli. |
Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment
|
|
Change in Outcome Expectancy Violation from Baseline to 6 Months Post-Treatment
Time Frame: Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment
|
Beliefs about potential harm associated with dental treatment will be assessed using the Harm Beliefs component of the Harm Beliefs and Coping Efficacy Interview. Changes in harm beliefs will be evaluated as an indicator of outcome expectancy violation and examined as a potential mediator of treatment outcomes. Perceived Likelihood (Probability): Rating how certain the participant is that a worst-case scenario will happen (from 0 Not Going to Happen to 8 Definitely Going to Happen). Perceived Severity (Impact): Rating the magnitude of the anticipated danger (from 0 Not Bad at All to 8 Very, Very Bad). |
Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent-Reported Treatment Satisfaction
Time Frame: 1 week, 6 months, and 12 months post-treatment
|
Parent satisfaction with the assigned treatment will be assessed using the parent version of the Treatment Satisfaction Survey. Scores will be compared between OSTD and RELAX at each follow-up assessment to evaluate parent-reported treatment satisfaction. Scores range from 12-60 with higher scores indicating more satisfaction. |
1 week, 6 months, and 12 months post-treatment
|
|
Child-Reported Treatment Satisfaction
Time Frame: 1 week, 6 months, and 12 months post-treatment
|
Child satisfaction with the assigned treatment will be assessed using the child version of the Treatment Satisfaction Survey. Scores will be compared between OSTD and RELAX at each follow-up assessment to evaluate child-reported treatment satisfaction. Scores range from 12-60 with higher scores indicating more satisfaction. |
1 week, 6 months, and 12 months post-treatment
|
|
Interventionist-Reported Treatment Satisfaction
Time Frame: Within 6 months of completion of treatment delivery for all study participants
|
Interventionists will complete the Acceptability of Intervention Measure (AIM) to evaluate their perceptions of treatment acceptability. Scores will be compared between OST-D and RELAX to assess differences in perceived acceptability. Interventionists will complete the Feasibility of Intervention Measure (FIM) to evaluate their perceptions of the feasibility of delivering the treatment. Scores will be compared between OST-D and RELAX to assess differences in perceived treatment feasibility. Interventionists will complete the Intervention Appropriateness Measure (IAM) to evaluate their perceptions of the appropriateness of the treatment for youth with dental phobia. Scores will be compared between OST-D and RELAX. Scores range from 4-20 with higher scores indicating greater acceptability, feasibility and appropriateness for each respective measure. |
Within 6 months of completion of treatment delivery for all study participants
|
|
Treatment Fidelity and Interventionist Competence
Time Frame: Treatment (Day 0)
|
Treatment fidelity and interventionist competence will be assessed using the study-specific Fidelity and Competence Coding Form. Selected treatment sessions will be evaluated to assess adherence to the assigned intervention protocol and competence in treatment delivery. 25% of sessions in each condition will be coded for fidelity and competence. |
Treatment (Day 0)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laura D Deligman, Ph.D., University of Texas Rio Grande Valley
- Principal Investigator: Joseph H Hovey, Ph.D., University of Texas Rio Grande Valley
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-113-E
- 4UH3DE031247-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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