Occupational Therapy Home Programs in Children With Down Syndrome

Not Applicable

Completed

• Conditions: Occupational Therapy; Feeding Problem; Down Syndrome
• Interventions: Other: Occupational therapy home program

• Registration Number: NCT06244108
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

Children with Down Syndrome frequently encounter difficulties with sensory functions and feeding, such as oral sensory processing issues and developmental disorders. The aim of this study was to examine the effects of an Occupational Therapy Home Program on the sensory functions and feeding issues of children with Down Syndrome.

Detailed Description

Although there are studies that investigate nutritional issues in children with Down syndrome, no well-structured, high-evidence, and individual-centered studies have been found. The literature assumes a relationship between the sensory functions and nutritional status of children with Down syndrome. Therefore, further studies are needed to develop intervention programs to prevent sensory processing and nutritional problems.

This study aims to evaluate the effectiveness of occupational therapy home programs in improving sensory functions and feeding problems in children with Down syndrome. The study focuses on evidence-based practices to assess the impact of these programs compared to not providing them.

The study will be conducted with children diagnosed with Down Syndrome who have applied to the Pediatrics Unit of the Department of Occupational Therapy at Hacettepe University Faculty of Health Sciences.

The study comprises pre-evaluation, final evaluation, and intervention stages. Following the initial evaluation, an occupational therapy home intervention program will be implemented for the children before and after each meal, seven days a week, for eight weeks. Evaluations will be repeated after the eight-week period.

Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2024-01-10
• Study First Submitted: 2024-01-10
• Study Completion: 2024-01-15
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Be between the ages of 3-10
• Having Down Syndrome
• Families agree to participate in the study

Exclusion Criteria

• Having previously received sensory integration and/or occupational therapy treatment
• Having a secondary diagnosis other than Down Syndrome (Mental Retardation, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTHP Group (Intervention Group)	Occupational therapy home program	Children with Down syndrome will undergo an 8-week occupational therapy home program (OTHP). Evaluations will be conducted at the beginning and end of the intervention, and the results will be compared.

Primary Outcome Measures

Name	Time	Method
Sensory Profile	8 weeks	The Sensory Profile developed by Winnie Dunn was used to evaluate sensory processing skills in Turkish. This assessment is suitable for children aged three to ten. The test is completed by an occupational therapist, accompanied by the person who has the most contact with the child in their daily life. Each item is scored on a Likert scale from 1 to 5. The Sensory Profile consists of three parts: sensory processing, modulation, and behavioral-emotional responses. Each part has 14 parameters. The score indicates the level of sensitivity, with lower scores indicating hypersensitivity, higher scores indicating hyposensitivity, and middle values indicating typical performance.
Screen Tool of Feeding Problems (STEP)	8 weeks	The study used the Systematic Tool for Evaluating Progress (STEP) to identify feeding challenges and problematic feeding behaviours experienced by individuals with Down Syndrome (DS). STEP includes questions for parents or personnel who have worked with the individual for the last six months, asking about any abnormal behaviours observed in the last month. The survey consists of 23 items, each addressing a specific nutritional issue. The aforementioned issues are categorized into five subgroups: aspiration risk, food selectivity, feeding skills, behavioural problems related to food rejection, and behavioural problems related to nutrition. The study used the Systematic Tool for Evaluating Progress (STEP) to identify feeding challenges and problematic feeding behaviours experienced by individuals with Down Syndrome (DS). An increase in the score suggests an increase in nutritional problems.
Demographic Form	8 weeks	The form completed by the child's primary caregiver includes information such as the child's age, gender, number of siblings, and the marital status of both parents.
A meal time	8 weeks	The study recorded the child's average meal time as reported by their parents during the first and last evaluations. The event was documented in the minutes.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Çankaya, Turkey