Autism Spectrum DisorderNCT05860829
Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Study
A study testing Educational in people with Autism Spectrum Disorder, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
The goal of this interventional study is to assess the knowledge of caregivers of children with Autism Spectrum Disorder (ASD) regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Educational
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesPakistan
- Study dates
- 23 May 2023to 21 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Caregivers of Children (5-18 years) with Autism enrolled in Autistic or specialized Schools.
- Caregivers able to communicate in English or Urdu or Sindhi.
- Caregiver of one child with Autism.
- Caregivers with smartphone/laptop/IPhone and internet facility.
Who cannot join
- Caregiver of child with Autism living with any known food allergies.
- Caregiver of child with Autism enrolled in any other trial.
- Caregiver of child with Autism and any other mental disorders.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Effort Welfare Trust
Karachi, Sindh
Markaz e Umeed
Karachi, Sindh
About this study
Official title: Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Stud
The goal of this interventional study is to assess the knowledge of caregivers of children with Autism Spectrum Disorder (ASD) regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children. The main aims to answer are:
Educating caregivers on
- Diet diversities
- Improving oral health habits Participants will have to
- Fill questionnaires
- Undergo educational sessions
- Fill post education questionnaires Researchers will compare pre and post educational questionnaires to see if the intervention makes a difference.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder defined by deficits in social communication and the presence of restricted and repetitive behaviors and interests. The disorder incorporates the constraints and typical behaviors in early childhood, which later becomes problematic to function in society. Although the reason of ASD are unexplained yet, however, air pollution, organic toxicants, seasonal factors, psychological stress, migration, birth order and nutrition may have a close relationship with the incidence of ASD. Emphasizing on the fact that it is a lifelong condition and there is no specific cure to it, it can only be managed and assisted by caregivers specially. Every individual with ASD have a unique and different behavioral pattern. These behavioral patterns are managed by experts of behavior management such as speech or occupational therapists.
Poor oral hygiene is widely reported among children with autism, thus can elevate the likelihood of dental cavities and bad breath. Dental health can be further deteriorated if a child with ASD prefers soft, sweet and sticky food preferences as unhealthy diet intake and limited diet diversity. Food selectivity and other feeding problems are endemic in children with autism spectrum disorders (ASD).
In Pakistan, few studies have comprehensively looked at the children with special needs.
As Pakistan is a Low-Middle-Income country (LMIC) with limited sources and ASD is a domain that still needs more research work to be done. There is a majority of population that overlook the topic and then there is a category that strongly believes myths and misconceptions that evolve regarding 'treatment' and management of Autism in individuals. Another setback is a limited number Professionals with sound knowledge of the disorder that can cater to majority individuals and their caregivers, providing assistance in how to manage the most basic things like oral hygiene and nutritional education - that can ultimately encourage the reduction of burden in caregivers.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Educational
- Keywords
- Oral hygiene, Nutrition literacy, Diet Diversity, Caregiver's experience, Telehealth, Caregiver
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalBehavioural
Caregivers of children with ASD will be sampled that are enrolled in Autism specialized Schools or centers. Tools and group education sessions will be developed in Urdu, English and Sindhi language. A caregiver education program session will be conducted by a practicing dentist and a registered dietitian in Urdu1 and English. Considering the ease of caregivers, cost-effectiveness and managing flexible hours, tele-health will be practiced for education program. A post-test will be conducted to assess the impact of the educational program on the knowledge of caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers of children with Autism Spectrum Disorder (ASD) | Experimental | Arm includes only the caregivers of children with ASD. The knowledge of caregivers of children with ASD regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children will be assessed. Then, educating caregivers on diet diversities, and effective oral health education, expecting from it to the eating habits and oral hygiene of children living with autism. Receives: Behavioral: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of nutrition education on nutrition literacy
Nutrition literacy Assessment Instrument (NLit) will be used to assess the nutrition literacy.
Measured: Including pre test, intervention and post test - will require 6 months (roughly).
Effect of nutrition education on diet diversity
Diet Diversity Score (DDS) will be used to assess diet diversity. There are twelve questions in this questionnaire. The number of food groups consumed by the child from the total number of twelve food groups will either be '0' or '1' which will be summed up. The scoring will be done, low will be ≤ 4 food groups, medium will be considered as 5 to 8 food groups, and high will be 9 to 12 food groups.
Measured: Including pre test, intervention and post test - will require 6 months (roughly).
Effect of oral hygiene education on oral hygiene practices.
Oral hygiene assessment score will be used to assess oral hygiene practices. There are a total of ten questions in this section. The interpretation will be done with the help of pre oral hygiene education and post oral hygiene education and the difference it creates among the caregivers of children with Autism.
Measured: Including pre test, intervention and post test - will require 6 months (roughly).
Secondary outcomes (1)
Assessment of experience of caregivers of children with Autism
Caregiver burden assessment scoring will be done by COPE Index. COPE index is a 15 item questionnaire developed to assess the caregiver experiences. Questions cover negative, positive and social aspects of caregiving. Score above 12 is for Negative Impact or below 12 for Positive Value.
Measured: Including pre test, intervention and post test - will require 6 months (roughly).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start23 May 2023
- Primary completion3 Aug 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pre-test will be conducted to explore the level of knowledge of the caregivers regarding oral hygiene and nutrition literacy of children with ASD. In-depth interviews will be conducted in order to identify the problems faced by caretakers till the saturation is reached. A semi-structured interview guide and caregiver education program will be developed related to dietary intake and oral hygiene of the child with autism for the caregivers. A dentist will provide education on oral hygiene and a registered dietician on nutrition literacy and diet diversity via telehealth. A post-test will be conducted after completion of all the sessions to assess the impact of the intervention.
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliya Haider, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860829
- Sponsor's protocol ID
- DowUniHS
- Status last verified
- May 2025
- First submitted
- 6 May 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Stud
- ClinicalTrials.gov ID
- NCT05860829
- Acronym / sponsor ID
- DowUniHS
- Conditions
- Autism Spectrum Disorder
- Keywords
- Oral hygiene, Nutrition literacy, Diet Diversity, Caregiver's experience, Telehealth, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to assess the knowledge of caregivers of children with Autism Spectrum Disorder (ASD) regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children. The main aims to answer are:
Educating caregivers on
- Diet diversities
- Improving oral health habits Participants will have to
- Fill questionnaires
- Undergo educational sessions
- Fill post education questionnaires Researchers will compare pre and post educational questionnaires to see if the intervention makes a difference.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder defined by deficits in social communication and the presence of restricted and repetitive behaviors and interests. The disorder incorporates the constraints and typical behaviors in early childhood, which later becomes problematic to function in society. Although the reason of ASD are unexplained yet, however, air pollution, organic toxicants, seasonal factors, psychological stress, migration, birth order and nutrition may have a close relationship with the incidence of ASD. Emphasizing on the fact that it is a lifelong condition and there is no specific cure to it, it can only be managed and assisted by caregivers specially. Every individual with ASD have a unique and different behavioral pattern. These behavioral patterns are managed by experts of behavior management such as speech or occupational therapists.
Poor oral hygiene is widely reported among children with autism, thus can elevate the likelihood of dental cavities and bad breath. Dental health can be further deteriorated if a child with ASD prefers soft, sweet and sticky food preferences as unhealthy diet intake and limited diet diversity. Food selectivity and other feeding problems are endemic in children with autism spectrum disorders (ASD).
In Pakistan, few studies have comprehensively looked at the children with special needs.
As Pakistan is a Low-Middle-Income country (LMIC) with limited sources and ASD is a domain that still needs more research work to be done. There is a majority of population that overlook the topic and then there is a category that strongly believes myths and misconceptions that evolve regarding 'treatment' and management of Autism in individuals. Another setback is a limited number Professionals with sound knowledge of the disorder that can cater to majority individuals and their caregivers, providing assistance in how to manage the most basic things like oral hygiene and nutritional education - that can ultimately encourage the reduction of burden in caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pre-test will be conducted to explore the level of knowledge of the caregivers regarding oral hygiene and nutrition literacy of children with ASD. In-depth interviews will be conducted in order to identify the problems faced by caretakers till the saturation is reached. A semi-structured interview guide and caregiver education program will be developed related to dietary intake and oral hygiene of the child with autism for the caregivers. A dentist will provide education on oral hygiene and a registered dietician on nutrition literacy and diet diversity via telehealth. A post-test will be conducted after completion of all the sessions to assess the impact of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Caregivers of children with Autism Spectrum Disorder (ASD) | Experimental | Behavioral: EducationalArm includes only the caregivers of children with ASD. The knowledge of caregivers of children with ASD regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children will be assessed. Then, educating caregivers on diet diversities, and effective oral health education, expecting from it to the eating habits and oral hygiene of children living with autism. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Caregivers of Children (5-18 years) with Autism enrolled in Autistic or specialized Schools.
- Caregivers able to communicate in English or Urdu or Sindhi.
- Caregiver of one child with Autism.
- Caregivers with smartphone/laptop/IPhone and internet facility.
Key exclusion criteria (3 listed)
- Caregiver of child with Autism living with any known food allergies.
- Caregiver of child with Autism enrolled in any other trial.
- Caregiver of child with Autism and any other mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationalCaregivers of children with ASD will be sampled that are enrolled in Autism specialized Schools or centers. Tools and group education sessions will be developed in Urdu, English and Sindhi language. A caregiver education program session will be conducted by a practicing dentist and a registered dietitian in Urdu1 and English. Considering the ease of caregivers, cost-effectiveness and managing flexible hours, tele-health will be practiced for education program. A post-test will be conducted to assess the impact of the educational program on the knowledge of caregivers. | Behavioural | Caregivers of children with Autism Spectrum Disorder (ASD) |
Primary outcome
Effect of nutrition education on nutrition literacy
Time frame: Including pre test, intervention and post test - will require 6 months (roughly).
Nutrition literacy Assessment Instrument (NLit) will be used to assess the nutrition literacy.
Effect of nutrition education on diet diversity
Time frame: Including pre test, intervention and post test - will require 6 months (roughly).
Diet Diversity Score (DDS) will be used to assess diet diversity. There are twelve questions in this questionnaire. The number of food groups consumed by the child from the total number of twelve food groups will either be '0' or '1' which will be summed up. The scoring will be done, low will be ≤ 4 food groups, medium will be considered as 5 to 8 food groups, and high will be 9 to 12 food groups.
Effect of oral hygiene education on oral hygiene practices.
Time frame: Including pre test, intervention and post test - will require 6 months (roughly).
Oral hygiene assessment score will be used to assess oral hygiene practices. There are a total of ten questions in this section. The interpretation will be done with the help of pre oral hygiene education and post oral hygiene education and the difference it creates among the caregivers of children with Autism.
1 secondary outcome
Assessment of experience of caregivers of children with Autism
Time frame: Including pre test, intervention and post test - will require 6 months (roughly).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational in people with Autism Spectrum Disorder, run by Dow University of Health Sciences at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nutrition education on nutrition literacy (time frame: Including pre test, intervention and post test - will require 6 months (roughly).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.