PrematureAHEMD-ISNCT05210959
The Turkish Version of the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
An observational study of Premature and Infant Development, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) is an instrument that assesses the quality and quantity of motor development opportunities available in the home for infants aged 3 to 18 months. Read more about this study
- Who is it for?
- Ages 3 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature, Infant Development, Environmental Exposure
- What is being tested?
- The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 10 Jan 2022
- How long will I take part?
- 2 Weeks
- 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: The study comprised of term and preterm newborns.
Who may be able to join
- Children aged 3-18 months
Who cannot join
- Children younger than 3 months or older than 18 months
- Congenital or systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Version of the Affordances in the Home Environment for Motor Development-Infant Scale and Its Cultural Adaptation in Turkish Population
The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) is an instrument that assesses the quality and quantity of motor development opportunities available in the home for infants aged 3 to 18 months. Since its initial publication, the AHEMD-IS has grown in popularity as a clinical tool and research criterion. Furthermore, the AHEMD-IS supports the claim that environmental factors can have a positive impact on future motor skills and later cognitive behaviors of infants. Also it is stated that environmental factors are associated with infant motor development and motor abilities. As of writing, it has been translated into eight languages from the original English version and has been reported as valid and reliable in countries such as China, Spain, Lebanon, and Persia. The aim of this study was to produce the Turkish version of the AHEMD-IS and to reveal the validity and reliability of this version.
Read the detailed description
The International Classification of Health, Function, and Disability (ICF), developed by the World Health Organization, provides a standard framework for identifying the body functions and structures, activity restrictions, and difficulties in children's participation. One of the major innovations in the ICF is that it introduces an environmental factor classification that enables the identification of environmental barriers and facilitators for both the capacity and performance of activities and tasks in daily life. The physical, social, and behavioral environments in which humans live are shaped by environmental factors. Environmental factors are external to the individual and can have a positive or negative impact on an individual's participation, performance, and body function/structure.
One of the tools that evaluate the environmental home environment is the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). The AHEMD-IS is a valuable tool for assessing the home environment, one of the environmental factors affecting infant motor development, and is of considerable research and clinical importance. The importance of this questionnaire is based on evidence not just for the impact of the home environment on motor development, but also on future cognitive and social behaviors. Consequently, this study aimed to translate the original English version into Turkish and to test its psychometric properties for use in children aged 3-18 months. It was aimed to determine whether the translated questionnaire meets the appropriate and necessary standards for measuring the quantity and quality of motor competencies in the home environment of children aged 3-18 month.
- Conditions
- Premature, Infant Development, Environmental Exposure
- Being tested
- The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)Other
The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) is an instrument that assesses the quality and quantity of motor development opportunities available in the home for infants aged 3 to 18 months. In this study, the Turkish version of the AHEMD-IS were constructed. Also, the validity and reliability of this version were examined.
| Study group | Role | What they receive |
|---|---|---|
| Preterm or term born infants | Premature or term born infants between the aged 3-18 months were recruited in this study. Receives: Other: The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) |
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 (AHEMD-IS)
The AHEMD-IS is a questionnaire for assessing the home environment of children aged 3 to 18 months. The AHEMD-IS evaluates physical space (inside and outside), variety of stimulation and play materials (gross motor toys and fine motor toys). The scale consists of 41 items in total. For infants aged 3-12 months, the first 32 items are answered. It is stated that the other items are not suitable for babies under 12 months. All substances are applied to infants aged 12-18 months. Questions answered as yes or no are scored as 0 and 1 (0: no, 1: yes). Other questions are scored as 0, 1, 2, 3. For infants up to 12 months, a total of 66 points is obtained. For infants older than 12 months, a total of 93 points is obtained. A higher score indicates better environmental enrichment
Measured: 2 weeks
Secondary outcomes (1)
Bayley Scales of Infant and Toddler Development -III (Bayley-III):
The Bayley-III is a widely used test battery to evaluate the cognitive, receptive, and expressive language, and gross and fine motor development in children aged 1-42 months. The cognitive scale in the Bayley-III test battery consists of 91 items. The receptive language scale consists of 49 items and the expressive language scale consists of 48 items. In the motor development section, the gross motor development scale consists of 72 items, and the fine motor development scale consists of 66 items. Items in each section are scored as 1 (can perform the desired skill) and 0 (cannot perform the desired skill). The raw scores obtained from all items are converted into scaled scores ranging from 1 to 19 points. Then, a composite score is obtained according to this scaled score. It is the composite score commonly used in studies. Composite scores range from 40 to 160. A higher score indicates better improvement.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Apr 2021
- Primary completion30 Dec 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Apaydin, Gazi University
- Investigators
- Bulent Elbasan, Prof., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210959
- Sponsor's protocol ID
- 91610558-604.01.02.
- Acronym
- AHEMD-IS
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cacola P, Gabbard C, Santos DC, Batistela AC. Development of the Affordances in the Home Environment for Motor Development-Infant Scale. Pediatr Int. 2011 Dec;53(6):820-5. doi: 10.1111/j.1442-200X.2011.03386.x.
PubMed 21507146Cacola PM, Gabbard C, Montebelo MI, Santos DC. Further Development and Validation of the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). Phys Ther. 2015 Jun;95(6):901-23. doi: 10.2522/ptj.20140011. Epub 2014 Dec 18.
PubMed 25524875Dinkel D, Snyder K, Cacola P. Affordances in the Home Environment for Motor Development-Infant Scale, Spanish Translation. Early Child Dev Care. 2019;189(5):802-810. doi: 10.1080/03004430.2017.1344653. Epub 2017 Jun 28.
PubMed 31217656Kavousipor S, Rassafiani M, Ebadi A, Solimani F, Hosseini A, Gabbard C. Cultural Adaptation and Psychometric Properties of the Persian Version of the Affordance in the Home Environment for Motor Development. Iran J Child Neurol. 2019 Winter;13(1):25-35.
PubMed 30598671
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Affordances in the Home Environment for Motor Development-Infant Scale and Its Cultural Adaptation in Turkish Population
- ClinicalTrials.gov ID
- NCT05210959
- Acronym / sponsor ID
- AHEMD-IS / 91610558-604.01.02.
- Conditions
- Premature, Infant Development, Environmental Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 27 Jan 2022 (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 Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) is an instrument that assesses the quality and quantity of motor development opportunities available in the home for infants aged 3 to 18 months. Since its initial publication, the AHEMD-IS has grown in popularity as a clinical tool and research criterion. Furthermore, the AHEMD-IS supports the claim that environmental factors can have a positive impact on future motor skills and later cognitive behaviors of infants. Also it is stated that environmental factors are associated with infant motor development and motor abilities. As of writing, it has been translated into eight languages from the original English version and has been reported as valid and reliable in countries such as China, Spain, Lebanon, and Persia. The aim of this study was to produce the Turkish version of the AHEMD-IS and to reveal the validity and reliability of this version.
Detailed description
The International Classification of Health, Function, and Disability (ICF), developed by the World Health Organization, provides a standard framework for identifying the body functions and structures, activity restrictions, and difficulties in children's participation. One of the major innovations in the ICF is that it introduces an environmental factor classification that enables the identification of environmental barriers and facilitators for both the capacity and performance of activities and tasks in daily life. The physical, social, and behavioral environments in which humans live are shaped by environmental factors. Environmental factors are external to the individual and can have a positive or negative impact on an individual's participation, performance, and body function/structure.
One of the tools that evaluate the environmental home environment is the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). The AHEMD-IS is a valuable tool for assessing the home environment, one of the environmental factors affecting infant motor development, and is of considerable research and clinical importance. The importance of this questionnaire is based on evidence not just for the impact of the home environment on motor development, but also on future cognitive and social behaviors. Consequently, this study aimed to translate the original English version into Turkish and to test its psychometric properties for use in children aged 3-18 months. It was aimed to determine whether the translated questionnaire meets the appropriate and necessary standards for measuring the quantity and quality of motor competencies in the home environment of children aged 3-18 month.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm or term born infants | – | Other: The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)Premature or term born infants between the aged 3-18 months were recruited in this study. |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study comprised of term and preterm newborns.
Key inclusion criteria (1 listed)
- Children aged 3-18 months
Key exclusion criteria (2 listed)
- Children younger than 3 months or older than 18 months
- Congenital or systemic disease
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 |
|---|---|---|
| The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) is an instrument that assesses the quality and quantity of motor development opportunities available in the home for infants aged 3 to 18 months. In this study, the Turkish version of the AHEMD-IS were constructed. Also, the validity and reliability of this version were examined. | Other | Preterm or term born infants |
Primary outcome
Affordances in the Home Environment for Motor Development (AHEMD-IS)
Time frame: 2 weeks
The AHEMD-IS is a questionnaire for assessing the home environment of children aged 3 to 18 months. The AHEMD-IS evaluates physical space (inside and outside), variety of stimulation and play materials (gross motor toys and fine motor toys). The scale consists of 41 items in total. For infants aged 3-12 months, the first 32 items are answered. It is stated that the other items are not suitable for babies under 12 months. All substances are applied to infants aged 12-18 months. Questions answered as yes or no are scored as 0 and 1 (0: no, 1: yes). Other questions are scored as 0, 1, 2, 3. For infants up to 12 months, a total of 66 points is obtained. For infants older than 12 months, a total of 93 points is obtained. A higher score indicates better environmental enrichment
1 secondary outcome
Bayley Scales of Infant and Toddler Development -III (Bayley-III):
Time frame: 2 weeks
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 15 Feb 2022.
- Background: PubMed 21507146Cacola P, Gabbard C, Santos DC, Batistela AC. Development of the Affordances in the Home Environment for Motor Development-Infant Scale. Pediatr Int. 2011 Dec;53(6):820-5. doi: 10.1111/j.1442-200X.2011.03386.x.
- Background: PubMed 25524875Cacola PM, Gabbard C, Montebelo MI, Santos DC. Further Development and Validation of the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). Phys Ther. 2015 Jun;95(6):901-23. doi: 10.2522/ptj.20140011. Epub 2014 Dec 18.
- Background: PubMed 31217656Dinkel D, Snyder K, Cacola P. Affordances in the Home Environment for Motor Development-Infant Scale, Spanish Translation. Early Child Dev Care. 2019;189(5):802-810. doi: 10.1080/03004430.2017.1344653. Epub 2017 Jun 28.
- Background: PubMed 30598671Kavousipor S, Rassafiani M, Ebadi A, Solimani F, Hosseini A, Gabbard C. Cultural Adaptation and Psychometric Properties of the Persian Version of the Affordance in the Home Environment for Motor Development. Iran J Child Neurol. 2019 Winter;13(1):25-35.
- Individual participant dataSharing planned: No
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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.
Bulent Elbasan, Prof. study director
Gazi 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 Premature and Infant Development, run by Gazi 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 1 inclusion and 2 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 15 Feb 2022. 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 (AHEMD-IS) (time frame: 2 weeks). 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 NCT05210959, which also lists 4 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 15 Feb 2022.