Clinical trial NCT05718427: Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD
Official title: Effect of Ayres Sensory Integration Therapy on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Ankara Medipol University
First posted: 2023-02-08
Enrollment: 94
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Sensory Integration and Praxis Test (SIPT)
timeFrame: 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.
measure: Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2)
timeFrame: 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.
measure: Goal Attainment Scale (GAS)
timeFrame: 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:
measure: Emotional Regulation Checklist (ERC)
timeFrame: 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.
measure: Childhood Executive Functions Inventory (CHEXI)
timeFrame: 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.
measure: Participation and Environment Scale for Children and Youth (PEM-CY)
timeFrame: 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.
measure: Stroop Test TBAG Form (Stroop TBAG)
timeFrame: 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:
measure: Sensory Profile (SP)
timeFrame: 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.
measure: Conners Parent Rating Scale (CPRS)
timeFrame: 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.
measure: Conners Teacher Rating Scale (CTRS)
timeFrame: 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.
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: