search
Back to results

Oral Health Education for Caregivers of Children With Disabilities

Primary Purpose

Developmental Disability

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral Health Educational Program for Caregivers of Children with developmental disabilities
Sponsored by
ElTyeb, Sara Amir Hassan, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Developmental Disability focused on measuring disability, developmental disability, special healthcare needs

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    selected randomly from a list of all the 105 special education centers registered at the State Ministry of Education, and randomly allocated into intervention group. all the children with developmental disabilities in enrolled in the school who met the eligibility criteria were examined and all their parents were interviewed. Caregivers' baseline knowledge and attitudes towards the oral healthcare of their children was assessed by an interview questionnaire. examination for the children with developmental disabilities was carried out to assess caregivers' practice by assessing the oral hygiene level and amount of unmet treatment needs. educational intervention by an Oral Health Education Program for Caregivers of Children with developmental disabilities about the oral health care of Children with DD, in the form of a short video, accompanied by demonstration & followed by an interactive discussion . the same evaluation was carried out again 3 months after the intervention.

    Evaluation of the knowledge, attitude and practice of caregivers of children with developmental disabilities towards the oral health of their children at baseline and 3 months after without any intervention.

    Outcomes

    Primary Outcome Measures

    improvement in oral hygiene status of children with developmental disabilities
    simplified oral hygiene index recorded from the oral examination of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.

    Secondary Outcome Measures

    improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children
    score of knowledge recorded in the interview questionnaire to the caregivers of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
    improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children
    score of attitude recorded in the interview questionnaire to the caregivers of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
    decrease in the unmet treatment needs of children with developmental disabilities
    score of unmet treatment needs recorded from the oral examination of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.

    Full Information

    First Posted
    May 13, 2017
    Last Updated
    May 16, 2017
    Sponsor
    ElTyeb, Sara Amir Hassan, M.D.
    Collaborators
    Sudan Medical Specialization Board (SMSB), Elfatih Malik, MD
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03157596
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    December 30, 2016 (Actual)
    Study Completion Date
    January 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    ElTyeb, Sara Amir Hassan, M.D.
    Collaborators
    Sudan Medical Specialization Board (SMSB), Elfatih Malik, MD

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Developmental Disability
    Keywords
    disability, developmental disability, special healthcare needs

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    selected randomly from a list of all the 105 special education centers registered at the State Ministry of Education, and randomly allocated into intervention group. all the children with developmental disabilities in enrolled in the school who met the eligibility criteria were examined and all their parents were interviewed. Caregivers' baseline knowledge and attitudes towards the oral healthcare of their children was assessed by an interview questionnaire. examination for the children with developmental disabilities was carried out to assess caregivers' practice by assessing the oral hygiene level and amount of unmet treatment needs. educational intervention by an Oral Health Education Program for Caregivers of Children with developmental disabilities about the oral health care of Children with DD, in the form of a short video, accompanied by demonstration & followed by an interactive discussion . the same evaluation was carried out again 3 months after the intervention.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Evaluation of the knowledge, attitude and practice of caregivers of children with developmental disabilities towards the oral health of their children at baseline and 3 months after without any intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Oral Health Educational Program for Caregivers of Children with developmental disabilities
    Intervention Description
    Oral Health Education Program for Caregivers of Children with developmental disabilities included information about health issues and obstacles encountered in children with DD & methods of prevention and management. It also emphasized on proper oral hygiene measures for this group. (University of Washington 2010)
    Primary Outcome Measure Information:
    Title
    improvement in oral hygiene status of children with developmental disabilities
    Description
    simplified oral hygiene index recorded from the oral examination of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children
    Description
    score of knowledge recorded in the interview questionnaire to the caregivers of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
    Time Frame
    3 months
    Title
    improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children
    Description
    score of attitude recorded in the interview questionnaire to the caregivers of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
    Time Frame
    3 months
    Title
    decrease in the unmet treatment needs of children with developmental disabilities
    Description
    score of unmet treatment needs recorded from the oral examination of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Oral Health Education for Caregivers of Children With Disabilities

    We'll reach out to this number within 24 hrs