| CTRI Number |
CTRI/2025/04/083996 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Social story and Visual pedagogy based pre-appointment behaviour guidance methods in children with ASD |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of Social story and Visual pedagogy based pre-appointment behaviour guidance methods in children with Autism Spectrum Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neil Godbole |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y Patil Dental College and Hospital, Pimpri Pune |
| Address |
Department of Pediatric and preventive dentistry, Dr. D. Y. Patil
Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune –
411018
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9881190975 |
| Fax |
|
| Email |
dr.neilgodbole98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunnypriyatham Thirupathi |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D. Y Patil Dental College and Hospital, Pimpri Pune |
| Address |
Department of Pediatric and preventive dentistry, Dr. D. Y. Patil
Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune –
411018
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9490549454 |
| Fax |
|
| Email |
dr.priyatham@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunnypriyatham Thirupathi |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D. Y Patil Dental College and Hospital, Pimpri Pune |
| Address |
Department of Pediatric and preventive dentistry, Dr. D. Y. Patil
Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune –
411018
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9490549454 |
| Fax |
|
| Email |
dr.priyatham@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Dental College and Hospital,Pimpri,Pune
|
| Prassanna Autism Centre, Deccan Gymkhana Pune-411004 |
| self funded |
|
|
Primary Sponsor
|
| Name |
DrNeil Godbole |
| Address |
Dr. D. Y Patil Dental College and Hospital, Pimpri Pune |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sadhana Godbole |
Prassana Autism Centre |
895Shivajinagar Deccan Gymkhana Pune Maharashtra
Pune
MAHARASHTRA |
9326013744
padmpurushfoundation@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Subethics Committee Dr.D.Y.Patil Dental College and Hospital Pune |
Approved |
| Prasanna Autism Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
Social Story |
the effectiveness of social story and visual pedagogy based pre-appointment behaviour guidance methods in children with Autism Spectrum Disorder.
Duration of intervention 6months |
| Comparator Agent |
Visual Pedagogy |
the effectiveness of social story and visual pedagogy based pre-appointment behaviour guidance methods in children with Autism Spectrum Disorder.
Duration of intervention 6 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with known diagnosis of Autism spectrum disorder belonging to age group of 6-12 years with no previous history of dental visit whose parents agree to participate in the study and have access to smart phones to show the pre recorded story or visual pedagogy to their child every day for a week before dental screening.
|
|
| ExclusionCriteria |
| Details |
Children with any other medical or developmental disability other than Autism Spectrum Disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the effectiveness of Social story based pre-appointment behaviour guidance technique in children with Autism spectrum disorder
2) To evaluate the effectiveness of Visual Pedagogy based pre-appointment behaviour guidance technique in children with Autism spectrum disorder
3) To compare the effectiveness of Social story and Visual Pedagogy based pre-appointment behaviour guidance techniques in children with Autism spectrum disorder
|
To compare the effectiveness of Social story and Visual Pedagogy based pre-appointment behaviour guidance techniques 1 week before in children with Autism spectrum disorder
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate parental perceptions regarding the two pre- appointment behaviour guidance methods. |
To evaluate parental perceptions regarding the two pre- appointment behaviour guidance methods at baseline & 1 week before dental checkup |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Autism Spectrum
Disorders (ASDs) are life-long neurodevelopmental disabilities and are major psychiatric
pathologies in children and adolescents.1 It includes a
group of developmental disabilities characterised by impaired social
interaction and communication, the presence of repetitive and stereotyped
behaviours and restricted interests (American Psychiatric Association 2013).
The prevalence was estimated to be
61.9/10,000 globally in 2012.2 India is a populous country of nearly 1.3 billion
people with children ≤15 years constituting nearly one-third of the
population. It has been estimated that more than 2 million people might be
affected with ASD in India2.
These children
with special healthcare needs are very frequently cited as having
difficulties complying with dental care procedures. There is also a higher
prevalence of anxiety among children
with ASD2. Behavioural intervention is the only well-established
approach to treat these disorders. Various strategies have been used to teach
children with autism to be compliant with medical procedures but research on
training these children to be compliant with dental procedures is scant.1-2
ASD may be associated with unusual responses
to sensory stimuli, such as oversensitivity to unfamiliar sounds, touch, and
heightened reactions to light.3 These special characteristics
often impede the children’s ability to cooperate in dental settings. For
years, studies have documented the insufficiency of dental care for children
with special needs, both in general and in particular for children with
Autism Spectrum Disorders (ASD)4. Providing dental care to
pediatric patients with ASD therefore presents a myriad of challenges to
providers. Individuals with ASD may not cope with routine social situations,
let alone one that is perceived as stressful and invasive, such as a dental
visit.
Traditional behavior management in pediatric
dentistry is often dependent upon the ability to communicate.4
Therefore, when caring for patients with communication difficulties, the
effectiveness of many behavioral techniques is reduced or eliminated5 Many
strategies are proposed to facilitate dental care for patients with ASD.
These include desensitization, creating an environment designed to be
minimally stimulating, structured appointments, and visual pedagogy6.Although
patients with ASD have similar dental needs to other patients, their unusual
responses to sensation can disrupt a dental visit and make proper care
difficult to provide.6
Social StoriesTM are a
behavioral intervention used for children with ASD. Social StoriesTM
generally consist of a short video describing a situation. They are often
used to generate a desired behavior, eliminate an undesirable one, or prepare
a child for a new experience.7 Social StoriesTM have
been shown to be useful in affecting nondental behavioral changes for about
60% of children with ASD, and this level of success may therefore be
achievable with similar types of preappointment training tools in a dental
setting.8
|
Visual Pedagogy, on the other hand, involves
the use of pictures/imagines either printed on paper or administered though
digital tools, such as computers, smartphones, and tablets.Such feasible
interactive aids are becoming more and more utilized with special needs
children.9 Visual pedagogy protocols foresee the use of
sketches to repetitively teach children
how to perform tooth brushing and which steps they will encounter during oral
examinations and preventive and/or restorative treatments9. The core
of visual pedagogy is that children with ASDs become familiar with the pictorial
storytelling that they will remember when in the dental office. Studies
have been carried out on this approach,
proving this to be effective in reducing anxiety and increasing compliance10
Although many studies have been carried out
|
about the
effectiveness of social story and visual pedagogy as a behaviour modification
method, there is very little literature pertaining to using these methods as
a pre appointment tool in children with ASD to increase their familiarity and
coping mechanism when it comes to visting the dentist.
Keeping these
two parameters in mind, this study aims to compare and evaluate the
effectiveness of social story and visual pedagogy based pre-appointment
behaviour guidance methods in children with Autism Spectrum Disorder.
7.2 Review of
Literature:
1. Fausar Sadia
Fakhruddin (2017) conducted a clinical trial in United Arab Emirates on the effectiveness of
audiovisual (AV) distraction in behavior modification during dental caries
assessment and sealant placement in children with autism spectrum disorder. It
was conducted on 28 children diagnosed with autism spectrum disorder, aged
6.5−9.8 years. The authors concluded that employing “tell‑show‑do modeling,
and AV distraction†approaches during initial treatment session helped
overcome communication barrier in this study. Use of animated cartoons
displayed on tablets, dental model, and playing with dough and toy dental
drill helped build communication bridges with the child participants. Initial
desensitization appointment and employing “tell‑show‑do†approach, followed
by short and positive treatment sessions, assisted in gaining cooperation and
improving behavior in these children.11
2. Janet WT Mah
(2016) conducted a randomized control trial in British Columbia to test
whether a visual schedule system using picture communication symbols can help
children with autism have successful routine dental cleaning visits. 14 boys
with autism between three- to eight-years-old presented to the dental clinic
for four weekly consecutive dental appointments. Patients were randomly
assigned to either the control group who received the tell-show do method
(i.e., standard of care), or the test group who received the tell-show-do
method plus the visual schedule system. The authors concluded that within
this pilot study, the use of a visual pedagogy approach, along with repeated
weekly visits, showed some promise in helping children with autism
successfully complete more steps, progress at a quicker rate, and exhibit
lower levels of behavioral distress within a dental exam and cleaning
appointment, compared to a tell show-do approach as part of standard care12.
|
3. Ebtissam Z. Murshid (2016) evaluated the
effectiveness of a specially designed dental book (preparatory aid) on the
behavior of a group of Autism Spectrum Disorder (ASD) children during their
first dental visit. A cross-sectional
double-blinded pre-and post clinical study consisting of 2 parts; a survey
targeting the parents, and a clinical oral examination of their ASD children
was conducted in 40 children. As
a part of the preratory aid, the author produced a children’s book to assist
both children and their parents in preparing for their first dental visit. The
data showed that the book was effective on the behavior of 37.5% of children
according to their parents’ opinion, whereas 97.5% of parents thought the book
was effective or highly effective in increasing their own dental knowledge.The
author concluded that educational and
behavioral preparation aids such as visual pedagogy, tablets and computer
applications, social
|
stories, books
and pictures series can also be used to describe a situation and designed to
prepare a child for a new experience.13
4. Ian W Marion
(2016) conducted a cross sectional study in United States of America to
investigate caregivers’ preference regarding dental stories to prepare
children with autism for dental visits. Caregivers of children with autism
were allowed the use of dental stories available via different media (paper,
tablet computer, computer) and image types (comics or drawings, photographs,
video). They also completed pre- and postintervention surveys. A “dental
story†consisting of 12 photographs and corresponding text was developed for
When presented with the option of print, digital, or a combination of stories
most caregivers selected digital stories (40%) or a combination of digital
and print stories (50%).The author concluded that a history of preparatory
story use and a child’s preference for home media serve as useful indicators
of future dental story preferences.This suggests that dental stories can
serve as a relatively simple, low cost, and effective tool that may assist
families of children with ASD prepare them for dental appointments.14
|
Step wise
chronological sequence
1)
Prior to the start of the study permission to
conduct the study will be taken from the school authorities.
2)
A one on one interaction with the parents of
children with ASD will be done on the
day of parent teacher meeting wherein the purpose of the study will be
explained. 3)
The parents will be asked to fill the Anxiety Scale
for Children – Autism Spectrum Disorder (ASC-ASD)© (Hindi version)
to evaluate the overall general anxiety in the child.It is a 24 item
self-report anxiety questionnaire, with four sub-scales: Separation Anxiety
(SA), Uncertainty (U), Performance Anxiety (PA) and Anxious Arousal (AA).
4)
Children will be selected according to the inclusion
and exclusion criteria.
|
1)
A written informed consent will be taken
from the parents and only those children whose parents have given written
consent for participation in the study will be included.
2)
The children
included in the study according to the inclusion exclusion criteria will be
randomly divided into 3 groups:
Group I: Control group (Without any pre appointment
behaviour guidance)
Group II: Social Story based Intervention
Group III: Visual Pedagogy based Intervention
3)
A customized
behaviour guidance method based on social story and visual pedogogy will be
prepared in the local languages. (Marathi and Hindi)
4)
One week
before dental screening, Social story/Visual Pedagogy will be shown to the
allocated groups of children through electronic screen/iPAD/Projector in the
school and the same will be sent to the parents through Whatsapp. Parents
will be instructed to show the same to their child everyday for the following
week before dental checkup.
5)
On the day of
the dental check up, the anxiety of the children will be assessed using a modification of ABEER Children Dental
Anxiety Scale (ACDAS).It is a prevalidated
scale of dental anxiety in children that can be completed by children
as young as 6 years of age among children with autism spectrum disorder.
10) The
behaviour and cooperation of the child will also be assessed by a second
operator who will be blinded about the group allocation. The behaviour of the
child will be assessed using a behaviour checklist based on the previously
published article by Hidayatullah et al.15
8.3
Duration of study: 1.5 years
8.4 Method of Data
Analysis: One
way ANOVA and post HOC
8.5 Does the study
require any investigation or intervention to be made on patients, any human
or animals? Yes
|
List of References
1.Cagetti MG, Mastroberardino S, Campus S, Olivari B,
Faggioli R, Lenti C, Strohmenger L. Dental care protocol based on visual
supports for children with autism spectrum disorders. Med Oral Patol Oral Cir
Bucal. 2015 Sep 1;20(5):e598-604. doi: 10.4317/medoral.20424. PMID: 26241453;
PMCID: PMC4598930.
2.Chauhan A, Sahu JK, Jaiswal N, Kumar K, Agarwal A, Kaur J,
Singh S, Singh M. Prevalence of autism spectrum disorder in Indian children:
A systematic review and meta-analysis. Neurol India 2019;67:100-4
|
3.Isong IA, Rao SR, Holifield C, Iannuzzi D, Hanson E, Ware
J, Nelson LP. Addressing dental fear in children with autism spectrum
disorders: a randomized controlled pilot study using electronic screen media.
Clin Pediatr (Phila). 2014 Mar;53(3):230-7. doi: 10.1177/0009922813517169.
Epub 2014 Jan 3. PMID: 24391123.
4.Murshid EZ. Effectiveness of a preparatory aid in
facilitating oral assessment in a group of Saudi children with autism
spectrum disorders in Central Saudi Arabia. Saudi Med J. 2017
May;38(5):533-540. doi: 10.15537/smj.2017.5.17398. PMID: 28439605; PMCID:
PMC5447216.
5.Marion IW, Nelson TM, Sheller B, McKinney CM, Scott JM.
Dental stories for children with autism. Spec Care Dentist. 2016
Jul;36(4):181-6. doi: 10.1111/scd.12167. Epub 2016 Mar 2. PMID: 26936501.
6.Kuhaneck HM, Chisholm EC. Improving dental visits for
individuals with autism spectrum disorders through an understanding of
sensory processing. Spec Care Dentist. 2012 Nov-Dec;32(6):229-33. doi:
10.1111/j.1754-4505.2012.00283.x. PMID: 23095065.
7.Gray
CA. Social stories and comic strip conversations with students with Asperger
syndrome and high-functioning autism. Asperger Syndrome or High Functioning
Autism? Springer US; 1998: 167-98.
8.Kokina A, Kern
L. Social StoryTM interventions for students with autism spectrum disorders:
a meta-analysis. J Autism Dev Disord 2010;40(7):812-26.
9.Bondy, A.;
Frost, L. The Picture Exchange Communication System. Behav. Modif. 2001, 25,
725–744
10.Fakhruddin,
K.S.; El Batawi, H.Y. Effectiveness of audiovisual distraction in behavior
modification during dental caries assessment and sealant placement in
children with autism spectrum disorder. Dent. Res. J. 2017, 14, 177–182.
[CrossRef]
11.Fakhruddin KS, El Batawi HY. Effectiveness of
audiovisual distraction in behavior modification during dental caries
assessment and sealant placement in children with autism spectrum disorder.
Dent Res J (Isfahan). 2017 May-Jun;14(3):177-182. doi:
10.4103/1735-3327.208768. PMID: 28702058; PMCID: PMC5504869.
12.Mah JW, Tsang P. Visual Schedule System in Dental Care
for Patients with Autism: A Pilot Study. J Clin Pediatr Dent.
2016;40(5):393-9. doi: 10.17796/1053-4628-40.5.393. PMID: 27617380.
13.Murshid EZ. Effectiveness of a preparatory aid in
facilitating oral assessment in a group of Saudi children with autism
spectrum disorders in Central Saudi Arabia. Saudi Med J. 2017
May;38(5):533-540. doi: 10.15537/smj.2017.5.17398. PMID: 28439605; PMCID:
PMC5447216.
14.Marion IW, Nelson TM, Sheller B, McKinney CM, Scott JM.
Dental stories for children with autism. Spec Care Dentist. 2016
Jul;36(4):181-6. doi: 10.1111/scd.12167. Epub 2016 Mar 2. PMID: 26936501.
15.(Hidayatullah,
Taufiqi & Agustiani, Hendriati & Setiawan, Arlette. (2018) Behavior
management-based applied behaviour analysis within dental examination of
children with autism spectrum disorder. Dental Journal (Majalah Kedokteran
Gigi). 51. 71. 10.20473/j.djmkg.v51.i2.p71-75)
|
|
|
|
|
|