Assessment of Skills and Behaviors in Children With Down Syndrome

Down Syndrome Clinical Trial

Official title:

Assessment of Skills and Behaviors in Children With Down Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04754178
• Other study ID #: DF0093UG
• Status: Not yet recruiting
• Start date: February 15, 2021
• Est. completion date: May 15, 2021

Study information

• Verified date: February 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 15, 2021
• Est. primary completion date: April 15, 2021
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• Down syndrome childrens

• Age between 0 and 3 years

Exclusion Criteria:

• Other physical or functional impairment that limits the performance of evaluation

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Locations

Country	Name	City	State
Spain	Faculty of Healthy Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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"	Baseline
Primary	Parent Perceptions of Physical Activity Scale	Evaluate the Parent Perceptions of Physical Activity in Families of Toddlers With Neurodevelopmental Disorders	Baseline
Primary	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.	Baseline
Primary	Early Clinical Assessment of Balance	The Early Clinical Assessment of Balance (ECAB) is a measure of postural stability for children.	Baseline
Primary	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.	Baseline
Primary	Asymmetry	Asymmetry was evaluated with photography	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Secondary	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)	Baseline
Secondary	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	Baseline
Secondary	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).	Baseline
Secondary	International physical activity questionnaire	The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations.	Baseline
Secondary	Charlson comorbidity index	Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions	Baseline
Secondary	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	Baseline