Oral Health Education for Caregivers of Children With Disabilities
Effectiveness of an Oral Health Education Program for Caregivers of Children With Developmental Disabilities: A Cluster Randomized Trial
1 other identifier
interventional
61
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2017
CompletedFirst Submitted
Initial submission to the registry
May 13, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedMay 17, 2017
May 1, 2017
6 months
May 13, 2017
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (3)
improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children
3 months
improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children
3 months
decrease in the unmet treatment needs of children with developmental disabilities
3 months
Study Arms (2)
intervention group
EXPERIMENTALselected 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.
control group
NO INTERVENTIONEvaluation 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- has a developmental disability.
- enrolled in any of the randomly selected special education schools.
- caregivers signed the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ElTyeb, Sara Amir Hassan, M.D.lead
- Sudan Medical Specialization Board (SMSB)collaborator
- Elfatih Malik, MDcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Sara Amir
Study Record Dates
First Submitted
May 13, 2017
First Posted
May 17, 2017
Study Start
July 1, 2016
Primary Completion
December 30, 2016
Study Completion
January 17, 2017
Last Updated
May 17, 2017
Record last verified: 2017-05