Sensory Adapted Dental Environment to Enhance Oral Care for Children With ASD (SADE)

University of Southern California

Status: Completed

Conditions: Autism

Treatments: Behavioral: Sensory Adapted Dental Environment

Study type: Interventional

Funder types: Other

Identifiers

NCT02077985

5R34DE022263-02

Details and patient eligibility

About

The goal of this project is to collect information that will support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. We hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights, smells and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders, and to a lesser extent for typically developing children especially those who have dental anxieties. This has the potential contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.

Full description

The goal of this R34 NIDCR Planning and Pilot Data Grant is to collect information to support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. Within this project, two groups of children were studied: children with autism spectrum disorders (ASD) and typically developing children, including those who are over-reactive to sensory stimulation. Commonly, such children exhibit anxiety and negative behavioral reactions when confronted with experiential aspects of dental visits such as exposure to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of various oral care products. We pilot tested a sensory adapted dental environment (SADE) to examine its effect on reducing anxiety and behavioral problems among the targeted groups of children. The SADE intervention includes such adaptations as dimmed lighting, exposure to soothing music, and application of a special vest which provides deep pressure sensations that are calming. If our preliminary assessment produces promising results, we will later more comprehensively test the intervention in a full-scale randomized clinical trial, which will be supported by a U01 award.

The specific aims of the R34 grant are to promote the ability to conduct the future trial by:

1. Developing a manual for the SADE intervention and assessing the intervention's feasibility.
2. Collecting preliminary data on the intervention's effectiveness and potential cost-savings.
3. Pilot testing the recruitment strategy and assessment battery that will be used in the anticipated trial.
4. Developing the system of documents and data management for the future trial.
5. Generating the proposal for the U01 award to conduct the planned trial.

Research participants were 45 ethnically diverse children aged 6-12 years, 22 with ASD and 23 who are typically developing. Each child underwent two dental cleanings four months apart: dental cleaning in a standard dental environment and dental cleaning in the sensory adapted environment. For each group of children (i.e., ASD and typically developing), these two conditions were compared in their effects on anxiety and negative behavioral reactions, as measured by videotape coding, psychophysiological indices, and various rating scales.

Enrollment: 45 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of autism using ADOS (or) typically developing
• age 6 to 12
• parents speak English or Spanish
• in need of an oral cleaning (no previous cleaning within past four months)

Exclusion criteria

• disability such as cleft palate, significant motor impairment (e.g cerebral palsy), no genetic, endocrine, or metabolic dysfunction that would interfere with oral care or EDA.

Additional exclusion for participants in Typical Group include

• diagnosis of ASD or other DD
• diagnosis of ADHD, anxiety disorder, bipolar disorder
• siblings not diagnosed with ASD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Regular Dental Environment

No Intervention group

Description:

There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.

Sensory Adapted Dental Environment

Experimental group

Description:

There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).

Treatment:

Behavioral: Sensory Adapted Dental Environment