Down SyndromeNCT04754178
Assessment of Skills and Behaviors in Children With Down Syndrome
An observational study of Down Syndrome, run by Universidad de Granada at 1 site in Spain.
Trial summary
Parents of children with Down Syndrome can help in describing children's abilities and behavior. Most of the studies evaluating parents of children with Down Syndrome and other intellectual disabilities have focused on parental stress and coping; Additionally, most research has evaluated the perspectives of mothers… Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Down Syndrome
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 15 May 2021
- 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 0 to 3 years
- All sexes
- Child
Study population: Patients with Down Syndrome
Who may be able to join
- Down syndrome childrens
- Age between 0 and 3 years
Who cannot join
- Other physical or functional impairment that limits the performance of evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Parents of children with Down Syndrome can help in describing children's abilities and behavior. Most of the studies evaluating parents of children with Down Syndrome and other intellectual disabilities have focused on parental stress and coping; Additionally, most research has evaluated the perspectives of mothers rather than fathers. For this reason, in this study we aims to evaluate skills and behaviors in children with Down syndrome through the perception of parents.
- Conditions
- Down Syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Down syndrome | Down syndrome patients and their parents | |
| Control group | Healthy children and their parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Motor Questionnaire
The EMQ is designed as a fast and easy to complete motor questionnaire, and is organized into 3 sections: Gross motor skills, fine motor skills, and perception-action integration skills. The EMQ is not a standardized assessment, but can be used in research settings, serve as a motor screener, or as complement to standardized measures of early motor development.
Measured: Baseline
Montreal's children's Hospital Feeding Scale
The Montreal Children's Hospital Feeding Scale (MCHFS) is a quick and reliable measure of feeding problems for clinical settings, but there is little examination of its relationship to commonly used research measures of parental feeding practice, child eating behaviour and observations of parent-infant interaction at mealtimes.
Measured: Baseline
Feeding Hándicap Índex Children
y the Feeding Handicap Index (FHI), [20] was developed and standardized on typically developing children, children with CP, Autism spectrum disorder in the age range of 2-10 years and Intellectual disability. FHI has 38 items related to statements related to physical (21), emotional (12) and functional (5) aspects of feeding and swallowing abilities. It has a 3 point rating scale (0, 1 \& 2) where "0" indicates the individual "Never has this problem", "1" indicates "Sometimes has this problem" and "3" indicates "Always has this problem"
Measured: Baseline
Parent Perceptions of Physical Activity Scale
Evaluate the Parent Perceptions of Physical Activity in Families of Toddlers With Neurodevelopmental Disorders
Measured: Baseline
Bayley Scales of Infant and Toddler Development
is an individually administered scale that assesses five key developmental domains in children between 1-42 months of age: cognition, language (receptive and expressive communication), motor (gross and fine), social-emotional and adaptive behavior. The first three are assessed through direct observation of the child in test situations, while the last two are assessed through questionnaires to be completed by the main caregiver.
Measured: Baseline
Early Clinical Assessment of Balance
The Early Clinical Assessment of Balance (ECAB) is a measure of postural stability for children.
Measured: Baseline
Infant Positioning Assessment Tool
The Infant Position AssessmentTool (IPAT) is a six-item tool with cumulative scores ranging from 0 to 12. It was developed as a teaching tool to standardize developmentally supportive positioning practices in the NICU and provides a method for evaluation of those positioning practices.
Measured: Baseline
Asymmetry
Asymmetry was evaluated with photography
Measured: Baseline
COMFORT behaviour scale
The COMFORT behaviour scale (COMFORT-B scale) is widely used in paediatric intensive care units to assess young children's pain and distress.
Measured: Baseline
Segmental Assessment of Trunk Control
The SATCo i,ii is a validated outcome measure that identifies at which head/trunk segment Targeted Training should commence. The SATCo determines the topmost (most cephalo) segment at which control of the upright posture is poor or not demonstrated i.e. is currently being learned for each of static, active and reactive control.
Measured: Baseline
Secondary outcomes (6)
EuroQol-5D
The perception of the level of health and the quality of life were evaluated with the questionnaire European Quality of
Life-5 Dimensions (EQ-5D). It is composed of 2 parts in which health status is assessed:
- Descriptive system: It consists on 5 dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients classify their health status in 3 severity levels: having no problems, having some or moderate problems, being unable to do/having extreme problems.
- Visual Analog Scale, by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)
Measured: Baseline
Hospital Anxiety and Depression Scale
Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS) . This scale is composed of 14 items divided into two subscales, 7 items of anxiety and 7 items of depression, involving higher values worse psycho-emotional state
Measured: Baseline
Zarit Burden Interview
The Zarit Burden Interview, is a popular caregiver self-report measure used by many aging agencies. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).
Measured: Baseline
International physical activity questionnaire
The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations.
Measured: Baseline
Charlson comorbidity index
Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions
Measured: Baseline
Brief Infant Sleep Questionnaire
The Brief Infant Sleep Questionnaire (BISQ) is used to assess sleep patterns, parent perception, and sleep-related behaviors in young children (0-36 months). The BISQ has been validated against actigraphy, daily logs, and has high sensitivity in documenting expected developmental trends in sleep
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Feb 2021 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion15 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754178
- Sponsor's protocol ID
- DF0093UG
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skills and Behaviors in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT04754178
- Acronym / sponsor ID
- DF0093UG
- Conditions
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 15 Feb 2021 (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.
Parents of children with Down Syndrome can help in describing children's abilities and behavior. Most of the studies evaluating parents of children with Down Syndrome and other intellectual disabilities have focused on parental stress and coping; Additionally, most research has evaluated the perspectives of mothers rather than fathers. For this reason, in this study we aims to evaluate skills and behaviors in children with Down syndrome through the perception of parents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Down syndrome | – | –Down syndrome patients and their parents |
| Control group | – | –Healthy children and their parents |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients with Down Syndrome
Key inclusion criteria (2 listed)
- Down syndrome childrens
- Age between 0 and 3 years
Key exclusion criteria (1 listed)
- Other physical or functional impairment that limits the performance of evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early Motor Questionnaire
Time frame: Baseline
The EMQ is designed as a fast and easy to complete motor questionnaire, and is organized into 3 sections: Gross motor skills, fine motor skills, and perception-action integration skills. The EMQ is not a standardized assessment, but can be used in research settings, serve as a motor screener, or as complement to standardized measures of early motor development.
Montreal's children's Hospital Feeding Scale
Time frame: Baseline
The Montreal Children's Hospital Feeding Scale (MCHFS) is a quick and reliable measure of feeding problems for clinical settings, but there is little examination of its relationship to commonly used research measures of parental feeding practice, child eating behaviour and observations of parent-infant interaction at mealtimes.
Feeding Hándicap Índex Children
Time frame: Baseline
y the Feeding Handicap Index (FHI), [20] was developed and standardized on typically developing children, children with CP, Autism spectrum disorder in the age range of 2-10 years and Intellectual disability. FHI has 38 items related to statements related to physical (21), emotional (12) and functional (5) aspects of feeding and swallowing abilities. It has a 3 point rating scale (0, 1 \& 2) where "0" indicates the individual "Never has this problem", "1" indicates "Sometimes has this problem" and "3" indicates "Always has this problem"
Parent Perceptions of Physical Activity Scale
Time frame: Baseline
Evaluate the Parent Perceptions of Physical Activity in Families of Toddlers With Neurodevelopmental Disorders
Bayley Scales of Infant and Toddler Development
Time frame: Baseline
is an individually administered scale that assesses five key developmental domains in children between 1-42 months of age: cognition, language (receptive and expressive communication), motor (gross and fine), social-emotional and adaptive behavior. The first three are assessed through direct observation of the child in test situations, while the last two are assessed through questionnaires to be completed by the main caregiver.
Early Clinical Assessment of Balance
Time frame: Baseline
The Early Clinical Assessment of Balance (ECAB) is a measure of postural stability for children.
Infant Positioning Assessment Tool
Time frame: Baseline
The Infant Position AssessmentTool (IPAT) is a six-item tool with cumulative scores ranging from 0 to 12. It was developed as a teaching tool to standardize developmentally supportive positioning practices in the NICU and provides a method for evaluation of those positioning practices.
Asymmetry
Time frame: Baseline
Asymmetry was evaluated with photography
COMFORT behaviour scale
Time frame: Baseline
The COMFORT behaviour scale (COMFORT-B scale) is widely used in paediatric intensive care units to assess young children's pain and distress.
Segmental Assessment of Trunk Control
Time frame: Baseline
The SATCo i,ii is a validated outcome measure that identifies at which head/trunk segment Targeted Training should commence. The SATCo determines the topmost (most cephalo) segment at which control of the upright posture is poor or not demonstrated i.e. is currently being learned for each of static, active and reactive control.
6 secondary outcomes
EuroQol-5D
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Baseline
Zarit Burden Interview
Time frame: Baseline
International physical activity questionnaire
Time frame: Baseline
Charlson comorbidity index
Time frame: Baseline
Brief Infant Sleep Questionnaire
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
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Down Syndrome
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.
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 Down Syndrome, run by Universidad de Granada at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. 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 Spain. 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?
Results are not available in the source record.
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?
Early Motor Questionnaire (time frame: Baseline). The study lists 10 primary outcomes in all. 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 15 Feb 2021.