Clinical trial NCT03157596: Oral Health Education for Caregivers of Children With Disabilities
Official title: Effectiveness of an Oral Health Education Program for Caregivers of Children With Developmental Disabilities: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disability
Keywords: disability
developmental disability
special healthcare needs
Lead sponsor: ElTyeb, Sara Amir Hassan, M.D.
Sponsor class: INDIV
Collaborators: name: Sudan Medical Specialization Board (SMSB)
name: Elfatih Malik, MD
First posted: 2017-05-17
Enrollment: 61
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Considering the impact of caregivers' oral health knowledge, attitudes and practices on the oral health of their children; we introduced an educational program to the parents and caregivers of children with developmental disabilities about the oral healthcare of their developmentally disabled children to rise up with the oral health status of those children.

Detailed description: * Target Population; Parents of Children with DD enrolled in selected special education centers in Khartoum state, Khartoum, Sudan, and their developmentally disabled children.
* A convenient sample of two special education centers were selected randomly from a list of all the 105 special education centers registered at the State Ministry of Education, and allocated into intervention and control groups.
* One center was used as case who received the educational program and the other center was used as a control group.
* Eligibility Criteria: child aged 3-18, with a developmental disability, caregivers approval to participate (signed the informed consent).
* All the Children who met the eligibility criteria in both centers were examined and all their parents were interviewed, before and after the intervention.
* An interview questionnaire for the parents of Children with DD in both centers was used to evaluate their knowledge and attitude toward the oral health care of their children before and 3 months after the intervention.
* Oral examination was carried out to determine the baseline oral hygiene level and treatment needs of the Children with DD, before the educational session.
* A second examination was carried out after a period of 3 months after the educational session, to determine any change in oral hygiene and treatment needs of the children after their parents and or caregivers' attendance to the educational session.
* The baseline and follow up examination were carried out blindly by a calibrated dentist.
* The same examiner carried out the baseline and follow up examinations to avoid any inter-examiner variations.
* Oral examination was arranged according to oral health surveys basic methods recommended by WHO in 2013.
* The Simplified Oral Hygiene Index (measuring debris index and calculus index).
* Dentition Status and Treatment Needs chart provided in oral health assessment forms for children by the WHO 2013 was used to determine the amount of unmet dental needs and help in evaluating the caregivers' oral healthcare behaviours and the frequency of dental visits.

Eligibility criteria: Inclusion Criteria:

* has a developmental disability.
* enrolled in any of the randomly selected special education schools.
* caregivers signed the informed consent.

Exclusion Criteria:

* not a student in any of the randomly selected special education schools.
* caregivers refused to participate and sign the informed consent.
* age not in the range of 3 - 18 years old.

Primary outcomes:
measure: improvement in oral hygiene status of children with developmental disabilities
timeFrame: 3 months
Secondary outcomes:
measure: improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children
timeFrame: 3 months
measure: improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children
timeFrame: 3 months
measure: decrease in the unmet treatment needs of children with developmental disabilities
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: