Study of Anxiety Free Experiences at the Dentist (SAFE-D)

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.