Clinical trial NCT05860829: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Oral hygiene
Nutrition literacy
Diet Diversity
Caregiver's experience
Telehealth
Caregiver
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 123
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Caregivers of Children (5-18 years) with Autism enrolled in Autistic or specialized Schools.
2. Caregivers able to communicate in English or Urdu or Sindhi.
3. Caregiver of one child with Autism.
4. Caregivers with smartphone/laptop/IPhone and internet facility.

Exclusion Criteria:

1. Caregiver of child with Autism living with any known food allergies.
2. Caregiver of child with Autism enrolled in any other trial.
3. Caregiver of child with Autism and any other mental disorders.

Primary outcomes:
measure: Effect of nutrition education on nutrition literacy
timeFrame: Including pre test, intervention and post test - will require 6 months (roughly).
measure: Effect of nutrition education on diet diversity
timeFrame: Including pre test, intervention and post test - will require 6 months (roughly).
measure: Effect of oral hygiene education on oral hygiene practices.
timeFrame: Including pre test, intervention and post test - will require 6 months (roughly).
Secondary outcomes:
measure: Assessment of experience of caregivers of children with Autism
timeFrame: Including pre test, intervention and post test - will require 6 months (roughly).
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Effort Welfare Trust
state: Sindh
city: Karachi
country: Pakistan
facility: Markaz e Umeed
state: Sindh
Study officials:
References: