Occupational Therapy Home Programs in Children With Down Syndrome

The Effect of Occupational Therapy Home Programs on Sensory Processing and Feeding Problems in Children With Down Syndrome: A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome; Occupational Therapy; Feeding Problem
• Intervention / Treatment: Other: Occupational therapy home program

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OTHP Group (Intervention Group); 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.	Other: Occupational therapy home program; After evaluating the children, an occupational therapy home intervention program will be developed for each child. The program will be monitored through telephone and computer interviews, as well as video, photo, and audio recordings. The interventions in this study were selected based on successful occupational therapy home programs for children with disabilities. The program consists of five steps. Step 1 is to establish collaborative relationships with parents. Step 2 is to determine the most appropriate goals for the child and their family. Step 3 involves selecting the most suitable therapeutic activities to achieve these goals. Step 4 is to educate and support parents in performing these therapeutic activities. Finally, Step 5 involves measuring the results and providing feedback.
No Intervention: None OTHP Group (Control group); The control group (non-OTHP) will not receive occupational therapy home program, even if they have Down syndrome. Evaluations will be conducted at 8-week intervals, with the first and last evaluations being compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Profile	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.	8 weeks
Screen Tool of Feeding Problems (STEP)	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.	8 weeks
Demographic Form	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.	8 weeks
A meal time	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.	8 weeks

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Director: Gökçen Akyürek, Assoc. Prof., Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Randomized; Occupational Therapy; Down Syndrome; Sensory Function; Home Program; Control Trial
• 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: Zengin0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study's completion is anticipated to result in a scientific article that will contribute to evidence-based practices.

Drug and device information, study documents

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