Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588062
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Effect of PECS in Improving Oral Hygiene Status Among Preschool Chidren
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Picture Exchange Communication System in Improving Oral Hygiene Status Among Preschool Children with Autism Spectrum Disorder-A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PECS
Brief Summary:
Background
Oral health is an important part of overall health of the children and precisely it is additionally imperative for children who need out of the ordinary or special health care Children with autism spectrum disorder normally face trouble in maintenance of good oral hygiene due to their incapacity to communicate and interact socially and are one such group lacking sufficient oral health knowledge to sustain their oral health owing to communication barriers
Objective
To assess and compare the effect of Picture Exchange Communication System PECS intervention on oral hygiene status of preschool children aged 4 to 6 years old with Autism Spectrum Disorder ASD over a period of three months
Methods
Children with confirmed diagnosis of autism will be randomly divided into two groups All the participants of both the groups intervention Group I and control Group II will receive conventional oral hygiene instructions in presence of their parents These instructions will be given on model showing each surface to be cleaned properly Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes Moreover instruction to avoid sugary diet will also be given Additionally the intervention participants Group I will be provided a set of 10 picture cards depicting brushing sequences and techniques by animated character for PECS intervention The plaque scores will be recorded in the two groups by using PI index by Silness Loe 1964 GI scores will also be recorded by using GI index Loe Silness 1963 using a periodontal probe at baseline Following the initial examination oral health education will be given on model to both groups in addition to this Group I will be demonstrated to use PECS intervention After three months follow up visit will be conducted in which plaque and gingival scores will be recorded again in both groups to assess the impact of PECS intervention on oral hygiene status of children with ASD
Oral health is an important part of overall health of the children and precisely it is additionally imperative for children who need out of the ordinary or special health care Children with autism spectrum disorder normally face trouble in maintenance of good oral hygiene due to their incapacity to communicate and interact socially and are one such group lacking sufficient oral health knowledge to sustain their oral health owing to communication barriers
Objective
To assess and compare the effect of Picture Exchange Communication System PECS intervention on oral hygiene status of preschool children aged 4 to 6 years old with Autism Spectrum Disorder ASD over a period of three months
Methods
Children with confirmed diagnosis of autism will be randomly divided into two groups All the participants of both the groups intervention Group I and control Group II will receive conventional oral hygiene instructions in presence of their parents These instructions will be given on model showing each surface to be cleaned properly Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes Moreover instruction to avoid sugary diet will also be given Additionally the intervention participants Group I will be provided a set of 10 picture cards depicting brushing sequences and techniques by animated character for PECS intervention The plaque scores will be recorded in the two groups by using PI index by Silness Loe 1964 GI scores will also be recorded by using GI index Loe Silness 1963 using a periodontal probe at baseline Following the initial examination oral health education will be given on model to both groups in addition to this Group I will be demonstrated to use PECS intervention After three months follow up visit will be conducted in which plaque and gingival scores will be recorded again in both groups to assess the impact of PECS intervention on oral hygiene status of children with ASD
Detailed Description:
RATIONALE OF STUDY The population with Autism Spectrum Disorder Syndrome ASD may require additional specific health needs due to their characteristic features Among them especially children are at risk of many diseases due to major barriers that are found in improving health and wellbeing because of lacking in health infrastructure in Pakistan There is vast knowledge gap and very limited research is available on this subject specially when investigated in context of Pakistan The scenario also worsens due to delayed diagnosis and treatment intervention to this population whereas when it comes to dental needs major factors are responsible for its unmet treatment needs The most important factors observed are lack of access to dental consultation affordability and refraining treatment provision by dentist as these children are sensitive to many stimuli due to which their cooperation and management is usually compromised This shows that it is essential to identify such existing voids and take remedial measures for it Evidence based behavioral management approaches will be key to develop and improve compliance with oral health for patients with ASD ASD children have difficulty in communication which leads to inability to interact socially This is due to their altered behavior patterns which includes restricted repetitive and stereotyped pattern of behavior Due to behavioral issues there is lack of compliance to maintenance of oral health As a result oral health is compromised and since the behavioral component makes them difficult to interact with the dentist their treatment management also gets difficult Hence focus should be done on prevention of oral diseases PECS is an effective behavioral tool for teaching ASD children basic oral health maintenance techniques In a low socioeconomic country like Pakistan where such disabled population is not given appropriate resources and workforce improving oral health status of such population through a cost effective technique like PECS may help lower the burden of the disease from ASD children
Since majority of studies have not been done as a case-control interventional or prospective cohort however most researches have not demonstrated or compared different technique techniques nor mentioned the comparison in-between the technique for instance the use of PECS with other conventional methods Therefore this study has been undertaken to carry out a randomized controlled trail using blinding to keep the information and results as confidential and authentic as possible For this reason this research will compare PECS test with controls conventional method for providing a comparative analysis as well as provide most reliable evidence on the effectiveness of the intervention by minimizing risk of confounding factors which will influence the results
STATEMENT OF PROBLEM Pakistan is considered as a Developing country with total population of 2166 million as of 2019 Despite of huge population Pakistan is trying to improve different sectors in different aspects including health care delivery system Unfortunately the health sector framework and infrastructure is still delivering poor quality and working in inefficient manner at many different levels due to many reasons Situation is found even worse for special population which includes people with disabilities mental health issues developmental and neurological disorder Similarly the scenario is not much differing for developmental and neurological disorder including ASD as well This lacking is observed almost at every level of policy making and implementation There is serious lacking in providing good institutions for their development health education and promotion However the scenario is same with oral health status and its promotion among autistic children in our country Though the disorder is not rare but as compared to developed countries relatively little reflection and attention has been drawn towards it Usually the attention is not drawn because people affected with autism are subject to stigma and discrimination As ASD children have difficulty in communication which leads to inability to interact socially due to their altered behavior patterns Due to these communication and behavioral issues there is lack of compliance to maintenance of oral health As a result oral health is compromised and since the behavioral component makes them difficult to interact and communicate with the dentist their treatment management also gets difficult Hence focus should be done on prevention of oral diseases Picture Exchange Communication System is one widely used approach to communicate and develop skills in these children
HYPOTHESIS
Null Hypothesis HO There is no effect of Picture Exchange Communication System PECS on oral hygiene status of preschool children with Autism Spectrum Disorder ASD
Alternate Hypotheses HA There is effect of Picture Exchange Communication System PECS on oral hygiene status of preschool children with Autism Spectrum Disorder ASD
SAMPLING TECHNIQUE
Purposive sampling technique will be used in this study After application of inclusion and exclusion criteria the selected children will be allocated in groups through randomization
RANDOMIZATION
Sequence Generation
After application of inclusion and exclusion criteria the selected 80 children will be numbered in the form of a list Each eligible child will be randomly allocated to interventional and control group via SNOSE
Allocation Concealment
Allocation to PECS intervention GROUP I and control GROUP II will be done by Sequentially Numbered Opaque Sealed Envelope SNOSE The allocation of participants in intervention and control group will be written on paper and kept in a sealed and labeled envelope with a serial number on it The researcher will assure the participants details before envelopes are opened
The study will follow a single blind criterion wherein the participant and their parentcaregiver will not be informed about the enrolment into which group
DATA COLLECTION PROCEDURE
RECRUITMENT AND ASSESSMENT
Parents of eligible children at organizations will be invited to participate in this clinical trial with their ASD affected child They will be provided with informed assent and details of study The written consent will be signed by each participants parent Data will be collected by administering a questionnaire inquired from parent or guardian and by performing oral examinations of the participants Performa will consist of demographic profile and autism assessment score The demographic profile will include information related to gender age ethnicity medical history family income and parents education Moreover information about previous interaction with Picture Exchange Communication System will also be included in this part of questionnaire
The autism assessment score will be achieved from special needs organization where the child in enrolled ASD and its severity will be assessed on the basis of CARS Childhood Autism Rating Scale At all special needs organization a qualified psychologist carries out CARS assessment of ASD children prior to recruitment and administration of therapies in routine Only children with mild to moderate CARS score in the range of 30-365 will be enrolled in this study If in case severity exceeds from required criteria above 37 then subjects will be excluded from the study at baseline as mentioned in the inclusion criteria Moreover this score will also be helpful in assessing cooperation level during oral examination
ORAL EXAMINATION
BASELINE EXAMINATION
The oral examination will be performed at baseline of each study participant This examination will be performed by principal investigator Dr Saqib Minhas by using sterilized periodontal probe Michigan-O Probe mouth mirrors and explorer under artificial light source Oral examinations will be carried out on the mobile dental unit at their respective institute Oral hygiene status will be assessed by using plaque index PI whereas gingival status by using gingival index GI The principal researcher will be trained and calibrated for intra examiner reliability for evaluation of oral hygiene indices For the purpose a pilot study will be conducted on 20 of total sample size And intra examiner reliability score of more than 80 will be acceptable Both indices readings of each participant will be recorded in Performa according to criteria of scoring ie GI readings are recorded as 01-1 Mild 11-2 Moderate and 21-3 Severe while for PI 0 Excellent 01-09 Good 1-19 Fair 2-3 Poor The following six index teeth Ramfjord teeth will be utilized to record PI and GI in the primary dentition 55 61 64 75 81 84 according to the FDI system24 An assistant will be available at all follow ups to assist the clinician
INTERVENTION
All the participants of both the groups intervention Group I and control Group II will receive conventional oral hygiene instructions in presence of their parents These instructions will be given on model showing each surface to be cleaned properly Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes Moreover avoidance of sugary diet will also be given The intervention participants Group I will be provided a set of 10 picture cards depicting brushing sequence and techniques by animated character24 The picture will be illustrating brushing of left and right buccal lingual labial and occlusal surfaces of maxillary and mandibular teeth The same systematic brushing steps and cleaning of all teeth and their surfaces will be demonstrated to their parents as well However PECS tool is used as is to avoid modification to the source 24 Each card will be accompanied by the instructions of specific step of technique with clear picture illustration for better understanding The same instructions will be provided again one week apart for development of skills
Final follow-up appointment will be scheduled at an interval of three months after intervention is applied If in case parents and child are unable to attend appointment reschedule will be done Three attempts will be made for rescheduling of follow-ups
FOLLOW UP EXAMINATION
Follow up will be conducted after one month and two month of baseline readings where reinforcement of technique will be performed and adherence will be assessed Oral examination will be conducted after three months in a similar manner as conducted at the time of baseline examination The reason for selecting three month follow up is that PI can be changed over a very short period of time depending on tooth brushing 24 There are evidences that testified an oral health promotion program using both group education and individual behavioral methods over a 12-week period will be effective in reducing dental plaque Each child will be given reward of his own choice from gift box at follow up The record noted at follow up will be used for evaluation of intervention implemented Since the clinician is involved in provision and dealing of community health services to special children eg of autism therefore it will be easier for the clinician to build up a rapport with the patients
OUTCOME The expected outcome of the study will be Assessment and comparison of changes observed in oral health with respect to application of PECS intervention in ASD children
OUTCOMEMEASURE
The outcome measures will be evaluated in follow up examination after a period of three months by defining changes observed in PI and GI scores calculated before and after intervention applied
VARIABLES
INDEPENDENT VARIABLES
Demographic Age gender child assessment criteria parents education family income
DEPENDENT VARIABLE
Outcome of intervention ie evaluation of oral hygiene GI and PI
Since majority of studies have not been done as a case-control interventional or prospective cohort however most researches have not demonstrated or compared different technique techniques nor mentioned the comparison in-between the technique for instance the use of PECS with other conventional methods Therefore this study has been undertaken to carry out a randomized controlled trail using blinding to keep the information and results as confidential and authentic as possible For this reason this research will compare PECS test with controls conventional method for providing a comparative analysis as well as provide most reliable evidence on the effectiveness of the intervention by minimizing risk of confounding factors which will influence the results
STATEMENT OF PROBLEM Pakistan is considered as a Developing country with total population of 2166 million as of 2019 Despite of huge population Pakistan is trying to improve different sectors in different aspects including health care delivery system Unfortunately the health sector framework and infrastructure is still delivering poor quality and working in inefficient manner at many different levels due to many reasons Situation is found even worse for special population which includes people with disabilities mental health issues developmental and neurological disorder Similarly the scenario is not much differing for developmental and neurological disorder including ASD as well This lacking is observed almost at every level of policy making and implementation There is serious lacking in providing good institutions for their development health education and promotion However the scenario is same with oral health status and its promotion among autistic children in our country Though the disorder is not rare but as compared to developed countries relatively little reflection and attention has been drawn towards it Usually the attention is not drawn because people affected with autism are subject to stigma and discrimination As ASD children have difficulty in communication which leads to inability to interact socially due to their altered behavior patterns Due to these communication and behavioral issues there is lack of compliance to maintenance of oral health As a result oral health is compromised and since the behavioral component makes them difficult to interact and communicate with the dentist their treatment management also gets difficult Hence focus should be done on prevention of oral diseases Picture Exchange Communication System is one widely used approach to communicate and develop skills in these children
HYPOTHESIS
Null Hypothesis HO There is no effect of Picture Exchange Communication System PECS on oral hygiene status of preschool children with Autism Spectrum Disorder ASD
Alternate Hypotheses HA There is effect of Picture Exchange Communication System PECS on oral hygiene status of preschool children with Autism Spectrum Disorder ASD
SAMPLING TECHNIQUE
Purposive sampling technique will be used in this study After application of inclusion and exclusion criteria the selected children will be allocated in groups through randomization
RANDOMIZATION
Sequence Generation
After application of inclusion and exclusion criteria the selected 80 children will be numbered in the form of a list Each eligible child will be randomly allocated to interventional and control group via SNOSE
Allocation Concealment
Allocation to PECS intervention GROUP I and control GROUP II will be done by Sequentially Numbered Opaque Sealed Envelope SNOSE The allocation of participants in intervention and control group will be written on paper and kept in a sealed and labeled envelope with a serial number on it The researcher will assure the participants details before envelopes are opened
The study will follow a single blind criterion wherein the participant and their parentcaregiver will not be informed about the enrolment into which group
DATA COLLECTION PROCEDURE
RECRUITMENT AND ASSESSMENT
Parents of eligible children at organizations will be invited to participate in this clinical trial with their ASD affected child They will be provided with informed assent and details of study The written consent will be signed by each participants parent Data will be collected by administering a questionnaire inquired from parent or guardian and by performing oral examinations of the participants Performa will consist of demographic profile and autism assessment score The demographic profile will include information related to gender age ethnicity medical history family income and parents education Moreover information about previous interaction with Picture Exchange Communication System will also be included in this part of questionnaire
The autism assessment score will be achieved from special needs organization where the child in enrolled ASD and its severity will be assessed on the basis of CARS Childhood Autism Rating Scale At all special needs organization a qualified psychologist carries out CARS assessment of ASD children prior to recruitment and administration of therapies in routine Only children with mild to moderate CARS score in the range of 30-365 will be enrolled in this study If in case severity exceeds from required criteria above 37 then subjects will be excluded from the study at baseline as mentioned in the inclusion criteria Moreover this score will also be helpful in assessing cooperation level during oral examination
ORAL EXAMINATION
BASELINE EXAMINATION
The oral examination will be performed at baseline of each study participant This examination will be performed by principal investigator Dr Saqib Minhas by using sterilized periodontal probe Michigan-O Probe mouth mirrors and explorer under artificial light source Oral examinations will be carried out on the mobile dental unit at their respective institute Oral hygiene status will be assessed by using plaque index PI whereas gingival status by using gingival index GI The principal researcher will be trained and calibrated for intra examiner reliability for evaluation of oral hygiene indices For the purpose a pilot study will be conducted on 20 of total sample size And intra examiner reliability score of more than 80 will be acceptable Both indices readings of each participant will be recorded in Performa according to criteria of scoring ie GI readings are recorded as 01-1 Mild 11-2 Moderate and 21-3 Severe while for PI 0 Excellent 01-09 Good 1-19 Fair 2-3 Poor The following six index teeth Ramfjord teeth will be utilized to record PI and GI in the primary dentition 55 61 64 75 81 84 according to the FDI system24 An assistant will be available at all follow ups to assist the clinician
INTERVENTION
All the participants of both the groups intervention Group I and control Group II will receive conventional oral hygiene instructions in presence of their parents These instructions will be given on model showing each surface to be cleaned properly Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes Moreover avoidance of sugary diet will also be given The intervention participants Group I will be provided a set of 10 picture cards depicting brushing sequence and techniques by animated character24 The picture will be illustrating brushing of left and right buccal lingual labial and occlusal surfaces of maxillary and mandibular teeth The same systematic brushing steps and cleaning of all teeth and their surfaces will be demonstrated to their parents as well However PECS tool is used as is to avoid modification to the source 24 Each card will be accompanied by the instructions of specific step of technique with clear picture illustration for better understanding The same instructions will be provided again one week apart for development of skills
Final follow-up appointment will be scheduled at an interval of three months after intervention is applied If in case parents and child are unable to attend appointment reschedule will be done Three attempts will be made for rescheduling of follow-ups
FOLLOW UP EXAMINATION
Follow up will be conducted after one month and two month of baseline readings where reinforcement of technique will be performed and adherence will be assessed Oral examination will be conducted after three months in a similar manner as conducted at the time of baseline examination The reason for selecting three month follow up is that PI can be changed over a very short period of time depending on tooth brushing 24 There are evidences that testified an oral health promotion program using both group education and individual behavioral methods over a 12-week period will be effective in reducing dental plaque Each child will be given reward of his own choice from gift box at follow up The record noted at follow up will be used for evaluation of intervention implemented Since the clinician is involved in provision and dealing of community health services to special children eg of autism therefore it will be easier for the clinician to build up a rapport with the patients
OUTCOME The expected outcome of the study will be Assessment and comparison of changes observed in oral health with respect to application of PECS intervention in ASD children
OUTCOMEMEASURE
The outcome measures will be evaluated in follow up examination after a period of three months by defining changes observed in PI and GI scores calculated before and after intervention applied
VARIABLES
INDEPENDENT VARIABLES
Demographic Age gender child assessment criteria parents education family income
DEPENDENT VARIABLE
Outcome of intervention ie evaluation of oral hygiene GI and PI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None