Developmental Delay DisorderNCT04556487
Turkish Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
An observational study of Developmental Delay Disorder and Genetic Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Environment which children live and grown is very important for the all development stages. In Turkey there is no measurement for home environment evaluation so our aim is to investigate the Psychometric Properties of the Turkish version of Affordances in the Home Environment for Motor Development-Infant Scale… Read more about this study
- Who is it for?
- Ages 3 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay Disorder, Genetic Disease, Metabolic Disease
- What is being tested?
- evaluation
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 15 Feb 2023
- Phase
- Observational
- 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 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Volunteer parents who have; * 3-18 months child/children * All children as typically developing children, genetic disorders, metabolic disorders, neuromotor disorders etc.
Who may be able to join
- Volunteer parents who have;
- 3-18 months child/children
- All children as typically developing children, genetic disorders, metabolic disorders, neuromotor disorders etc.
Who cannot join
- Parents who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Psychometric Properties of the Turkish Version of Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Environment which children live and grown is very important for the all development stages. In Turkey there is no measurement for home environment evaluation so our aim is to investigate the Psychometric Properties of the Turkish version of Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) in a sample of Turkısh children.
Read the detailed description
With the advances in technology and medical fields, the rate of cerebral palsy is increasing worldwide with the increase in the survival rate of preterm, low birth weight babies and neurodevelopmentally risky babies living in neonatal intensive care units.
The International Classification of Health, Function and Disability - Child and Youth version (ICF-CY), developed by the World Health Organization, provides a common language to record problems involving functions and structures of the body, restrictions of activity and participation that occur in childhood and adolescence, and related environmental factors; and It was developed to use terminology and consists of four main components: "Body Functions", "Body Structures", "Activity and Participation", "Environmental Factors". According to ICF-CY, environmental factors that have an effect on activity and participation are changeable factors. Therefore, it is stated that environmental conditions should be changed, redesigned and the child-supportive environment should be increased in order to increase the level of activity and participation in children.
Preschool children spend most of their time at home and playing games. Toys in the game environment, playmates, parental participation and attitude play a major role in the development of the child's motor and cognitive skills and social participation (6, 7). In recent years, the importance and positive effects of the enriched environment on the motor and cognitive development of babies have been emphasized in studies. Regular neuromotor evaluations and follow-up of risky babies are guiding in establishing an early intervention program. The "Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)" scale, developed to evaluate the characteristics of the environment in which babies live, is a valid and reliable scale that is frequently used in the literature in many different areas such as hearing loss, motor developmental delay, sensory impairment, and typical development. is a scale (8-11). Translation has been done in many different languages so far. Turkish infants at risk on a scale to evaluate the home environment in Turkey within our existing information is not yet available. It is thought that the introduction of the AHEMD-IS scale into the Turkish language will give clinicians and academicians a different perspective in the evaluation of risky babies and children.
- Conditions
- Developmental Delay Disorder, Genetic Disease, Metabolic Disease, Congenital Disorders, Musculoskeletal Diseases
- Being tested
- evaluation
- Medical subject headings
- Developmental Disabilities, Genetic Diseases, Inborn, Metabolic Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluationOther
we will evaluate the home environment of the children asking by parents
What is being measured
The primary outcome is the main question the study is designed to answer.
Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Psychometric properties will be investigated. AHEMD-IS have 41 items with 3 section as outside and inside environment, daily activities and toys. Questions are answered in three categories: dichotomous, 4-degree likert and explanation-based. Higher scores means good environmental enrichment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Apr 2021
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental Delay DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge ÇANKAYA, Hacettepe University
- Investigators
- Özge Çankaya, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556487
- Sponsor's protocol ID
- GO-2020
- Status last verified
- Mar 2023
- First submitted
- 16 Sep 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Eunson P. Aetiology and epidemiology of cerebral palsy. J Paediatr Child Health. 2012;22(9):361-6.
2. World Health Organization. (2007). International Classification of Functioning, Disability, and Health: Children & Youth Version: ICF-CY. World Health Organization.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Psychometric Properties of the Turkish Version of Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
- ClinicalTrials.gov ID
- NCT04556487
- Acronym / sponsor ID
- GO-2020
- Conditions
- Developmental Delay Disorder, Genetic Disease, Metabolic Disease, Congenital Disorders, Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 Sep 2020 (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.
Environment which children live and grown is very important for the all development stages. In Turkey there is no measurement for home environment evaluation so our aim is to investigate the Psychometric Properties of the Turkish version of Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) in a sample of Turkısh children.
Detailed description
With the advances in technology and medical fields, the rate of cerebral palsy is increasing worldwide with the increase in the survival rate of preterm, low birth weight babies and neurodevelopmentally risky babies living in neonatal intensive care units.
The International Classification of Health, Function and Disability - Child and Youth version (ICF-CY), developed by the World Health Organization, provides a common language to record problems involving functions and structures of the body, restrictions of activity and participation that occur in childhood and adolescence, and related environmental factors; and It was developed to use terminology and consists of four main components: "Body Functions", "Body Structures", "Activity and Participation", "Environmental Factors". According to ICF-CY, environmental factors that have an effect on activity and participation are changeable factors. Therefore, it is stated that environmental conditions should be changed, redesigned and the child-supportive environment should be increased in order to increase the level of activity and participation in children.
Preschool children spend most of their time at home and playing games. Toys in the game environment, playmates, parental participation and attitude play a major role in the development of the child's motor and cognitive skills and social participation (6, 7). In recent years, the importance and positive effects of the enriched environment on the motor and cognitive development of babies have been emphasized in studies. Regular neuromotor evaluations and follow-up of risky babies are guiding in establishing an early intervention program. The "Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)" scale, developed to evaluate the characteristics of the environment in which babies live, is a valid and reliable scale that is frequently used in the literature in many different areas such as hearing loss, motor developmental delay, sensory impairment, and typical development. is a scale (8-11). Translation has been done in many different languages so far. Turkish infants at risk on a scale to evaluate the home environment in Turkey within our existing information is not yet available. It is thought that the introduction of the AHEMD-IS scale into the Turkish language will give clinicians and academicians a different perspective in the evaluation of risky babies and children.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Volunteer parents who have; * 3-18 months child/children * All children as typically developing children, genetic disorders, metabolic disorders, neuromotor disorders etc.
Key inclusion criteria (3 listed)
- Volunteer parents who have;
- 3-18 months child/children
- All children as typically developing children, genetic disorders, metabolic disorders, neuromotor disorders etc.
Key exclusion criteria (1 listed)
- Parents who refuse to participate in the study
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 |
|---|---|---|
| evaluationwe will evaluate the home environment of the children asking by parents | Other | – |
Primary outcome
Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Time frame: 6 months
Psychometric properties will be investigated. AHEMD-IS have 41 items with 3 section as outside and inside environment, daily activities and toys. Questions are answered in three categories: dichotomous, 4-degree likert and explanation-based. Higher scores means good environmental enrichment.
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 3 Mar 2023.
- Background1. Eunson P. Aetiology and epidemiology of cerebral palsy. J Paediatr Child Health. 2012;22(9):361-6.
- Background2. World Health Organization. (2007). International Classification of Functioning, Disability, and Health: Children & Youth Version: ICF-CY. World Health Organization.
- 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.
Özge Çankaya, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Delay Disorder and Genetic Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 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 3 Mar 2023. 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 Turkey (Türkiye). 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?
Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) (time frame: 6 months). 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 NCT04556487, which also lists 2 linked publications.
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 3 Mar 2023.