Occupational Therapy Home Programs in Children With Down Syndrome

NCT ID: NCT06244108

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-01-15

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.

Conditions

Down Syndrome; Occupational Therapy; Feeding Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Occupational therapy home program

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gökçen Akyürek, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Hacettepe University

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Zengin0001

Identifier Type: -

Identifier Source: org_study_id