Occupational Therapy Home Programs in Children With Down Syndrome

NCT06244108 | Completed

• 1 other identifier: Zengin0001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Occupational Therapy; Feeding Problem

Keywords

Down Syndrome; Occupational Therapy; Home Program; Sensory Function; Randomized; Control Trial

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

OTHP Group (Intervention Group)

EXPERIMENTAL

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

None OTHP Group (Control group)

NO INTERVENTION

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.

Interventions

Occupational therapy home program 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.

OTHP Group (Intervention Group)

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Hacettepe University

Ankara, Çankaya, Turkey (Türkiye)

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 Officials

• Gökçen Akyürek, Assoc. Prof.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups. Intervention and control groups.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 6, 2024
• Study Start: January 10, 2023
• Primary Completion: January 10, 2024
• Study Completion: January 15, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)