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

NCT ID: NCT05718427

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Although there are studies in the literature showing the presence of Sensory Integration Disorder (SID) in children with ADHD, most researchers have studied a similar profile, such as sensory modulation disorder, and few have investigated all components of sensory integration (such as sensory perception, praxis). More research is needed to confirm the effects of Ayres Sensory Integration (ASI) therapy in children with ADHD and the possible relationship between SID-based difficulties in activities of daily living and ADHD symptoms. In our study, it was aimed to investigate the effect of Ayres Sensory Integration therapy on sensory, motor, cognitive, behavioral and social participation in children with ADHD in the light of extensive literature and recommendations.

ASI therapy will be applied to the intervention group, and the first assessment will be applied to the control group and the second assessment will be made 10 weeks later. However, after a 10-week waiting period, ASI therapy intervention will be applied after the second evaluation so that the children in the control group can also benefit from the intervention. ASI therapy intervention will be applied for 10 weeks, 3 times a week, with a session duration of 1 hour. Inclusion criteria: Being diagnosed with ADHD according to the DSM-V criteria, taking medication, being between the ages of 6 and 8 and attending school. Exclusion criteria: Having previously received sensory integration therapy, having another diagnosis in addition to the ADHD diagnosis.

In addition to drug therapy, ASI therapy will be applied to children in the intervention group. In the intervention group, ASI 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.

The children in the control group will be given only drug treatment. 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, ASI therapy will be applied 3 days a week with 60 minutes each session in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ayres Sensory Integration Therapy Group

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.

Group Type EXPERIMENTAL

Ayres Sensory Integration Therapy

Intervention Type 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.

Waiting Group

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ayres Sensory Integration Therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Having previously received sensory integration therapy,
* Having another diagnosis in addition to the ADHD diagnosis.
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Medipol University

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Busra Kaplan Kilic

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2022/44353

Identifier Type: -

Identifier Source: org_study_id

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