Assessment of Skills and Behaviors in Children With Down Syndrome

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 Overview

• Status: Unknown
• Conditions: Down Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18016
    • Faculty of Healthy Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Down Syndrome

Description

Inclusion Criteria:

• Down syndrome childrens
• Age between 0 and 3 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Down syndrome; Down syndrome patients and their parents
Control group; Healthy children and their parents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Parent Perceptions of Physical Activity Scale	Evaluate the Parent Perceptions of Physical Activity in Families of Toddlers With Neurodevelopmental Disorders	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.	Baseline
Early Clinical Assessment of Balance	The Early Clinical Assessment of Balance (ECAB) is a measure of postural stability for children.	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.	Baseline
Asymmetry	Asymmetry was evaluated with photography	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.	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
International physical activity questionnaire	The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations.	Baseline
Charlson comorbidity index	Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions	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	Baseline

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2021
• Primary Completion (Anticipated): April 15, 2021
• Study Completion (Anticipated): May 15, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: DF0093UG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No