NCT03157596

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 13, 2017

Last Update Submit

May 16, 2017

Conditions

Keywords

disabilitydevelopmental disabilityspecial healthcare needs

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

EXPERIMENTAL

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.

Other: Oral Health Educational Program for Caregivers of Children with developmental disabilities

control group

NO 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.

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)

intervention group

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

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