Developmental DisabilityNCT06263777
Early Detection of Children With Developmental Disabilities in Assiut Governorate
A study testing Nurses training program on early detection of disability in people with Developmental Disability and Development Delay, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Developmental Disability, Development Delay, Motor Delay
- What is being tested?
- Nurses training program on early detection of disability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Sep 2021
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The study was conducted in selected health units in Assiut, an Upper Egypt Governorate, in selected villages:
- far from the main government services,
- without access to public or subsidized transportation to and from the selected villages, and
- without the presence of any allied health professionals (physical therapists, occupational therapists, speech and language therapists, psychologists), who do not offer any of these medical services.
- The selected nurses should be
- employed by the village health department in the public sector,
- locals of the village where the health unit is located,
- and untrained in the early identification or examination of disabled children.
Who cannot join
- other than inclusion criteria
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tayseer Saber Abdeldayem
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: Nurses Training Program for Early Detection of Children With Developmental Disabilities
The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years).
Read the detailed description
A group of twenty-one licensed nurses with professional experience ranging from 5 to 11 years participated in the study. The participants completed the measurements to evaluate their current knowledge, practice, and perception pre-, post-, and follow-up of the training program in relation to the early detection of disabilities.
- Conditions
- Developmental Disability, Development Delay, Motor Delay, Down Syndrome, Autism Spectrum Disorder
- Being tested
- Nurses training program on early detection of disability
- Keywords
- Nurses training, early detection, early intervention, developmental disabilities, children
- Medical subject headings
- Developmental Disabilities, Learning Disabilities, Psychomotor Disorders, Down Syndrome, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurses training program on early detection of disabilityOther
It included four main elements, which are: a booklet defining different disabilities, a list of the guidelines for early detection, a guide for family guidance for families of children with disabilities, a monitoring and follow-up form for 8 cases of children with disabilities). The program consisted of twelve training sessions with a total of 48 hours (4 hours per session) and was based on the techniques of lecture, dialogue, working groups, cooperative learning techniques and participatory learning
| Study group | Role | What they receive |
|---|---|---|
| Nurses group | Experimental | Nurse training program on early detection of disability. It included four main elements, which are: a booklet defining different disabilities; a list of the guidelines for early detection; a guide for family guidance for families of children with disabilities; and a monitoring and follow-up form for cases of children with disabilities. Receives: Other: Nurses training program on early detection of disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire of Screening and referral knowledge
percentage of nurses' knowledge about screening and referral of all types of developmental disabilities. minimum score is worst, while maximum is the best
Measured: 1 month
Questionnaire of Disability Perception
The degree of needs of children with developmental delays and the importance of early intervention. minimum score is worst, while maximum is the best
Measured: 1 month
questionnaire about Monitoring Practices
Types of nurses' practices about developmental delay monitoring and assessment.minimum score is worst, while maximum is the best
Measured: 1 month
Follow up
The program's long-term learning effect was measured by the previous outcomes. Minimum score is worst, while maximum is the best
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jan 2021
- Primary completion15 Mar 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayseer Saber Younes, Beni-Suef University
- Investigators
- Tayseer S Abdeldayem, PhD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263777
- Sponsor's protocol ID
- P.T.REC/012/004142
- Status last verified
- Feb 2024
- First submitted
- 26 Nov 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to any other researchers
Publications
Chödrön, G., Pizur-Barnekow, K., Viehweg, S., Puk-Ament, A., & Barger, B. (2019). Childcare providers' attitudes, knowledge, and practice related to developmental monitoring to promote early identification and referral Early Child Development and Care, 1-15. https://doi.org/10.1080/03004430.2019.1626373
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses Training Program for Early Detection of Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT06263777
- Acronym / sponsor ID
- P.T.REC/012/004142
- Conditions
- Developmental Disability, Development Delay, Motor Delay, Down Syndrome, Autism Spectrum Disorder
- Keywords
- Nurses training, early detection, early intervention, developmental disabilities, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Feb 2024 (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.
The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years).
Detailed description
A group of twenty-one licensed nurses with professional experience ranging from 5 to 11 years participated in the study. The participants completed the measurements to evaluate their current knowledge, practice, and perception pre-, post-, and follow-up of the training program in relation to the early detection of disabilities.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurses group | Experimental | Other: Nurses training program on early detection of disabilityNurse training program on early detection of disability. It included four main elements, which are: a booklet defining different disabilities; a list of the guidelines for early detection; a guide for family guidance for families of children with disabilities; and a monitoring and follow-up form for cases of children with disabilities. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The study was conducted in selected health units in Assiut, an Upper Egypt Governorate, in selected villages:
- The selected nurses should be
- employed by the village health department in the public sector,
- locals of the village where the health unit is located,
- and untrained in the early identification or examination of disabled children.
Key exclusion criteria (1 listed)
- other than inclusion criteria
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 |
|---|---|---|
| Nurses training program on early detection of disabilityIt included four main elements, which are: a booklet defining different disabilities, a list of the guidelines for early detection, a guide for family guidance for families of children with disabilities, a monitoring and follow-up form for 8 cases of children with disabilities). The program consisted of twelve training sessions with a total of 48 hours (4 hours per session) and was based on the techniques of lecture, dialogue, working groups, cooperative learning techniques and participatory learning | Other | Nurses group |
Primary outcome
Questionnaire of Screening and referral knowledge
Time frame: 1 month
percentage of nurses' knowledge about screening and referral of all types of developmental disabilities. minimum score is worst, while maximum is the best
Questionnaire of Disability Perception
Time frame: 1 month
The degree of needs of children with developmental delays and the importance of early intervention. minimum score is worst, while maximum is the best
questionnaire about Monitoring Practices
Time frame: 1 month
Types of nurses' practices about developmental delay monitoring and assessment.minimum score is worst, while maximum is the best
Follow up
Time frame: 2 months
The program's long-term learning effect was measured by the previous outcomes. Minimum score is worst, while maximum is the best
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 16 Feb 2024.
- Results publicationChödrön, G., Pizur-Barnekow, K., Viehweg, S., Puk-Ament, A., & Barger, B. (2019). Childcare providers' attitudes, knowledge, and practice related to developmental monitoring to promote early identification and referral Early Child Development and Care, 1-15. https://doi.org/10.1080/03004430.2019.1626373
- Individual participant dataSharing planned: No. IPD will not be available to any other researchers
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Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
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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.
Tayseer S Abdeldayem, PhD principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurses training program on early detection of disability in people with Developmental Disability and Development Delay, run by Beni-Suef University at 1 site in Egypt.
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 8 inclusion and 1 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 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Questionnaire of Screening and referral knowledge (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263777, which also lists 1 linked publication.
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 16 Feb 2024.