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Completed

NCT Number: NCT03157596

Oral Health Education for Caregivers of Children With Disabilities

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.

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Key information

Conditions

Developmental Disability Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Health Educational Program for Caregivers of Children with developmental disabilities

Other

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 outcomes

  1. improvement in oral hygiene status of children with developmental disabilities

    Time frame: 3 months

    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 outcomes

  1. improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children

    Time frame: 3 months

    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.

  2. improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children

    Time frame: 3 months

    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.

  3. decrease in the unmet treatment needs of children with developmental disabilities

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

ElTyeb, Sara Amir Hassan, M.D.

Indiv

Collaborators

  • Elfatih Malik, MD
  • Sudan Medical Specialization Board (SMSB)

Registry information

Official study title

Effectiveness of an Oral Health Education Program for Caregivers of Children With Developmental Disabilities: A Cluster Randomized Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 17, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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