Assessment of Skills and Behaviors in Children With Down Syndrome

NCT04754178 | Unknown

• 1 other identifier: DF0093UG
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (6)

• EuroQol-5D

  Baseline

• Hospital Anxiety and Depression Scale

  Baseline

• Zarit Burden Interview

  Baseline

• International physical activity questionnaire

  Baseline

• Charlson comorbidity index

  Baseline

Study Arms (2)

Down syndrome

Down syndrome patients and their parents

Control group

Healthy children and their parents

Eligibility Criteria

• Age: 0 Years - 3 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients with Down Syndrome

You may qualify if:

• Down syndrome childrens
• Age between 0 and 3 years

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Healthy Sciences

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; PT; PhD

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 15, 2021
• Study Start: February 15, 2021
• Primary Completion: April 15, 2021
• Study Completion: May 15, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)