Developmental DisabilityNCT03157596
Oral Health Education for Caregivers of Children With Disabilities
A study testing Oral Health Educational Program for Caregivers of Children with developmental disabilities in people with Developmental Disability, run by ElTyeb, Sara Amir Hassan, M.D..
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Developmental Disability
- What is being tested?
- Oral Health Educational Program for Caregivers of Children with developmental disabilities
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 17 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- has a developmental disability.
- enrolled in any of the randomly selected special education schools.
- caregivers signed the informed consent.
Who cannot join
- 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.
About this study
Official title: Effectiveness of an Oral Health Education Program for Caregivers of Children With Developmental Disabilities: A Cluster Randomized Trial
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.
Read the 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.
- Conditions
- Developmental Disability
- Being tested
- Oral Health Educational Program for Caregivers of Children with developmental disabilities
- Keywords
- disability, developmental disability, special healthcare needs
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Educational Program for Caregivers of Children with developmental disabilitiesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jul 2016
- Primary completion30 Dec 2016
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElTyeb, Sara Amir Hassan, M.D.
- Collaborators
- Sudan Medical Specialization Board (SMSB), Elfatih Malik, MD
- Responsible party
- Principal investigator, Dr. Sara Amir Hassan ElTyeb, ElTyeb, Sara Amir Hassan, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157596
- Sponsor's protocol ID
- 3600 - SMSB
- Status last verified
- May 2017
- First submitted
- 13 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Oral Health Education Program for Caregivers of Children With Developmental Disabilities: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03157596
- Acronym / sponsor ID
- 3600 - SMSB
- Conditions
- Developmental Disability
- Keywords
- disability, developmental disability, special healthcare needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- ElTyeb, Sara Amir Hassan, M.D.
- Collaborators
- Sudan Medical Specialization Board (SMSB), Elfatih Malik, MD
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Oral Health Educational Program for Caregivers of Children with developmental disabilitiesselected 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 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- has a developmental disability.
- enrolled in any of the randomly selected special education schools.
- caregivers signed the informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Health Educational Program for Caregivers of Children with developmental disabilitiesOral 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) | Other | intervention group |
Primary outcome
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.
3 secondary outcomes
improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children
Time frame: 3 months
improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children
Time frame: 3 months
decrease in the unmet treatment needs of children with developmental disabilities
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health Educational Program for Caregivers of Children with developmental disabilities in people with Developmental Disability, run by ElTyeb, Sara Amir Hassan, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in oral hygiene status of children with developmental disabilities (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.