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临床试验/CTRI/2025/04/083996
CTRI/2025/04/083996
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Comparative evaluation of effectiveness of Social story and Visual pedagogy based pre-appointment behaviour guidance methods in children with Autism Spectrum Disorder

DrNeil Godbole1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年4月30日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
DrNeil Godbole
入组人数
45
试验地点
1
主要终点
1) To evaluate the effectiveness of Social story based pre-appointment behaviour guidance technique in children with Autism spectrum disorder

概览

简要总结

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.

  1. 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)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Children with any other medical or developmental disability other than Autism Spectrum Disorder.

结局指标

主要结局

1) To evaluate the effectiveness of Social story based pre-appointment behaviour guidance technique in children with Autism spectrum disorder

时间窗: 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

2) To evaluate the effectiveness of Visual Pedagogy based pre-appointment behaviour guidance technique in children with Autism spectrum disorder

时间窗: 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

3) To compare the effectiveness of Social story and Visual Pedagogy based pre-appointment behaviour guidance techniques in children with Autism spectrum disorder

时间窗: 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

次要结局

  • 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)

研究者

发起方
DrNeil Godbole
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Neil Godbole

Dr. D. Y Patil Dental College and Hospital, Pimpri Pune

研究点 (1)

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