NCT06470724

Brief Summary

The objective of the study are:

  1. 1.Evaluating the effectiveness of the structural-visual model of behavioral approach on the compliance and cooperativity of children with ASD in dental examinations.
  2. 2.Analyzing the association between the predicting factors and compliance in the step of dental examination.
  3. 3.Analyzing the association between the predicting factors and cooperativity in dental examinations.
  4. 4.Evaluating the effectiveness of the structural-visual model of behavioral approach on the compliance
  5. 5.Evaluating the effectiveness of the structural-visual model of behavioral approach on cooperativity of children with ASD in dental examinations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 12, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

Autism spectrum Disorder,visual pedagogystructuralcooperativitydental examination

Outcome Measures

Primary Outcomes (2)

  • Compliance of dental step of examination

    Compliance with dental step examination These steps (a) through (j) were given scores from 1 to 10: 1. Going into the dental room (score 1): 2. Sitting down (score 2): 3. Lying back in the dentist chair (score 3) 4. Tolerating direct light on the face (score 4 5. Mouth open wide and teeth showing (score 5) 6. Being able to handle having your mouth touched with gloves on (score 6) 7. Looking at yourself in the mirror (score 7) 8. Check over with tooth explorer (score 8) 9. Exam with bathroom mirror and tooth probe (score 9) 10. Tooth blockage (score 10)

    The duration of the research process spanned a period of 3 months. 1. The initial visit was pre-tested to assess the degree of cooperativity. 2. The second through sixth visits were conducted with a one-week gap. This is a visit for intervention, l

  • Cooperativity

    During pre- and post-tests, the Frankl Behavior Scale was used to measure how cooperative the kids were. According to Frankl (1962) and Klein (1999), the scale was split into four groups: 1. Definitely Not Good The patient doesn't want to get treatment, cries, is scared, fights, and is very negative. 2. Negative: Not wanting to get dental care, not following through, and having a negative attitude, but not too much. 3. Good news The patients are willing to go to the doctor, don't mind any treatment, follow directions, and work together. 4. Definitely positive Gets along well with the dentist, is interested in treatments, smiles, and seems to enjoy the situation.

    The duration of the research process spanned a period of 3 months. 1. The initial visit was pre-tested to assess the degree of cooperativity. The second through sixth visits were conducted with a one-week gap. This is a visit for intervention, last

Study Arms (1)

intervention of structural visual approach

EXPERIMENTAL

1. st visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy 2. nd visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, audio-visual modelling 3. rd visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, in vivo modelling 4. th visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, behavioral trials 5. th visit): Intervensi: T-S-F-D, auto-modeling, behavioral trial

Behavioral: Structural visual approach

Interventions

The intervention comprised seven behavior approaches in this research defined as follows: A successive approach: An approach to familiarization with the unfamiliar environment of the simulated dental office. Tell-Feel-Show-Do (T-F-S-D): A dental approach explained to the patient's treatment by telling the patient what would happen, what he felt or did, and what had been done. Visual pedagogy: Introduced dentistry to autistic children through visual media, such as pictures and photographs. Audiovisual modeling: A learning process through audiovisual media, such as video and animation. In-vivo modeling: Learning new activities by watching them in front of the model. Behavioral trials: A learning strategy conducted through practicing the recent activity by him/herself. Auto-modeling: A learning process following the activity of editing pictures during the prior visit of the patient.

intervention of structural visual approach

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged between 6 and 18 years old (school-aged children in Indonesia).
  • Good general health without physical disabilities.
  • Cooperative parents/caregivers who provided informed consent to participate in the study.
  • They reside in the same household as their parents/caregivers.
  • Diagnosis of autism spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) by a psychiatrist.

You may not qualify if:

  • a. Had undergone training for dental examination in a dental setting. b. The dental approach could not be provided due to a lack of non-pharmacological behavior management or cooperative behavior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Muhammadiyah Yogyakarta Dental Hospital

Yogyakarta, 55252, Indonesia

Location

Related Publications (1)

  • Elmore JL, Bruhn AM, Bobzien JL. Interventions for the Reduction of Dental Anxiety and Corresponding Behavioral Deficits in Children with Autism Spectrum Disorder. J Dent Hyg. 2016 Apr;90(2):111-20.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants did not know about the intervention and neither did a research assistant as an assessor who only provided assessments without involving the intervention.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intervention Day of Intervention Structural Intervention 1. st visit :Successive approaches,T-S-F-D,visual pedagogy 2. nd visitSuccessive approaches,T-S-F-D, visual pedagogy, audio-visual modelling 3. nd visit: Successive approaches, T-S-F-D, visual pedagogy, in vivo modelling 4. h visit: Successive approaches, T-S-F-D, visual pedagogy, behavioral trials 5. th visit:T-S-F-D, auto-modeling, behavioral trial The intervention in the process of dental examination lasted within 5 times of dental visit. During the pre-intervention test, the dentist asked the child to submit to the 10 steps of the dental examination but did not force the child to comply and cooperativity was measured by Frankl Behavior Scale, and the assessment/post-test was conducted 3 times. dentist explained the steps using photographs and images, and the assistant filmed this activity.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 24, 2024

Study Start

October 4, 2021

Primary Completion

April 23, 2022

Study Completion

May 1, 2022

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

IPD is not shared with other parties because it is in accordance with the statement submitted in the ethics submission.

Locations