Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD

NCT05718427 | Completed DMC

• 1 other identifier: 2022/44353
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Attention Deficit Hyperactivity Disorder (ADHD) is a very common neurodevelopmental disorder in childhood characterized by short attention span, impulsivity and hyperactivity. It is also known that sensory integration problems are seen together with the basic symptoms of ADHD. Studies indicate that children with ADHD have difficulties in perceiving and processing sensory stimuli, and in relation to this, they have difficulty in producing appropriate sensory responses at school, at home and in social environments. However, it was observed that the interventions related to ADHD did not focus on the sensory-motor dimension enough, and focused more on cognitive or social skills. Although current research indicates the presence of sensory integration disorder in children with ADHD, there are no studies showing the effectiveness of sensory integration intervention. Our study was planned to examine the effect of Ayres Sensory Integration intervention on sensory-motor, cognitive, behavioral skills and social participation in children with ADHD. Materials and Methods: After the evaluation, 90 children with ADHD will be included in the study by dividing them into intervention (n=45) and control (n=45) groups by simple randomization method. Ayres Sensory Integration Therapy intervention will be applied to the intervention group for 10 weeks, 3 times a week, with a session duration of 1 hour, while the control group will continue the drug treatment and after a waiting period of 10 weeks, Ayres Sensory Integration Therapy will be applied after the second evaluation. Participants, Sensory Profile (SP), Sensory Integration and Praxis Test (SIPT), Emotion Regulation Checklist (ERC), Stroop Test TBAG Form (Stroop TBAG), Childhood Executive Functions Inventory (CHEXI), Participation and Environment Scale for Children and Adolescents (PEM-CY), Conners Teacher Rating Scale (CTRS), Conners Parent Rating Scale (CPRS), Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) and Goal Achievement Scale (GAS) both before and before intervention. and post-group change as well as between-group differences will be evaluated.

Conditions

Attention Deficit Disorder With Hyperactivity; Sensory Integration Disorder; Motor Activity; Cognitive Deficit in Attention; Behavior Hyperactive; Emotional Regulation; Social Skills

Keywords

ADHD; Sensory Integration; Motor Performance

Outcome Measures

Primary Outcomes (3)

• Sensory Integration and Praxis Test (SIPT)

  Developed by Ayres, is a standardized performance-based observational test that evaluates sensory perception and sensory perception-based skills in detail in children between the ages of 4 and 8 years and 11 months. SIPT, is one of the important gold tests in evaluating sensory development.

  SIPT will also be used in the initial and final assessment at week 1 and week 12. SIPT measures the change in sensory skills.Getting a high score on the test means good performance.

• Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2)

  Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) is a test developed for children aged 4-21 and developed to measure the motor functions of children. BOT-2 is an observational assessment evaluating motor performance, consisting of 8 subtests and 12 items in total. It consists of fine motor accuracy, fine motor integration, dexterity, bilateral coordination, balance, upper extremity coordination, endurance, speed and agility subtests.

  BOT-2 will also be used in the initial and final assessment at week 1 and week 12. BOT-2 measures the change in motor skills. Getting a high score on the test means good performance.

• Goal Attainment Scale (GAS)

  The Goal Attainment Scale (GAS) is used to evaluate the achievement of functional therapy goals in children receiving treatment in pediatric services. It helps to set priorities and clear goals for intervention. It provides the child's continuous interest in the set goals and offers a person-centered approach. The determined goals should be specific, measurable, achievable, relevant and well-timed. While applying GAS, goals are set for the child and possible outcomes are defined for each goal. After a certain intervention, the functional status of the child is determined again. GAS consists of 5 points as -2, -1, 0, +1 and +2. A score of -2 indicates the child's pre-intervention baseline level, a score of -1 indicates a development below the expected attainment level, a score of 0 indicates an expected attainment level, a score of +1 indicates a better-than-expected achievement, and a score of +2 indicates that the child performs much better than expected.

  GAS will also be used in the initial and final assessment at week 1 and week 12. GAS measures the change in behavior. Maximum +2 and minimum -2 points are taken. +2 means the best result.

Secondary Outcomes (4)

• Emotional Regulation Checklist (ERC)

  ERC will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about emotional regulation behaviour in child. Getting a high score on the test means good performance.

• Childhood Executive Functions Inventory (CHEXI)

  CHEXI will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about executive functions skills in child. Getting a high score on the test means good performance.

• Participation and Environment Scale for Children and Youth (PEM-CY)

  PEM-CY will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about participation area in child. Getting a high score on the test means good performance.

• Stroop Test TBAG Form (Stroop TBAG)

  Stroop TBAG will also be used in the initial and final assessment at week 1 and week 12. Stroop TBAG measures the change in cognitive skills. Getting a high score on the test means good performance.

Other Outcomes (3)

• Sensory Profile (SP)

  SP will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data. The results are interpreted as exact difference, probable difference and typical performance.

• Conners Parent Rating Scale (CPRS)

  CPRS will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective by parent data about child general behaviour. Getting a high score on the test means good performance.

• Conners Teacher Rating Scale (CTRS)

  CTRS will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective by teacher data about child school behaviour. Getting a high score on the test means good performance.

Study Arms (2)

Ayres Sensory Integration Therapy Group

EXPERIMENTAL

Ayres Sensory Integration (ASI) therapy will be applied to children in the intervention group. In the intervention group, Ayres Sensory Integration Therapy will be performed 3 days a week for a total of 10 weeks, 60 minutes each session, in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM). A manualized protocol will be followed based on the principles of ASI-FM, Ayres sensory integration.

Behavioral: Ayres Sensory Integration Therapy

Waiting Group

NO INTERVENTION

The children in the control group will be wait just 10 weeks. The second evaluation will be repeated 10 weeks after the first evaluation. In order for the children in the control group to benefit from sensory integration therapy, after a 10-week waiting period, after the result measurements are applied again, Ayres sensory integration therapy will be applied 3 days a week with 60 minutes each session in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM).

Interventions

Ayres Sensory Integration Therapy BEHAVIORAL

Ayres sensory integration theory provides evidence from basic and applied science about the ability to receive, sort, process, and make use of the information originating from the body and the environment and perceived by our senses (touch, gravity, body position and movement, sight, smell, hearing, taste). This sensory information goes to the brain, where it is organized and interpreted. As a result, we form a plan of action that allows us to have an adaptive response appropriate for the demands of the environment. A thorough assessment guides the preparation of goals addressing the referring concerns and the recommendations for intervention. Ayres Sensory Integration intervention is provided within the context of professional practice. It is designed to improve sensory perceptual abilities, self-regulation, motor skills, and praxis. In doing so, it supports the client's ability to show improved behavior, learning, and social participation.

Ayres Sensory Integration Therapy Group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• According to the DSM-V criteria diagnosed with ADHD-C type,
• To be on medication,
• To be between the ages of 6 and 8,
• To attend school.

You may not qualify if:

• Having previously received sensory integration therapy,
• Having another diagnosis in addition to the ADHD diagnosis.

Sponsors & Collaborators

• Hacettepe University: lead
• Ankara Medipol University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Motor Activity; Spasm; Emotional Regulation; Social Skills

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: February 8, 2023
• Study Start: March 29, 2023
• Primary Completion: February 18, 2024
• Study Completion: August 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)