Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05718427
Study type Interventional
Source Hacettepe University
Contact Gonca Bumin, Prof
Phone +903123052560
Email gbumin@hacettepe.edu.tr
Status Recruiting
Phase N/A
Start date March 29, 2023
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT00202605 - Safety and Efficacy of SPD465 in Adults With ADHD Phase 2
Not yet recruiting NCT02677519 - A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD Phase 4
Completed NCT02730572 - Concerta (Methylphenidate) -To-Generic Switch Study N/A
Completed NCT01681082 - Psychological Effects of Tai Chi Training N/A
Active, not recruiting NCT01330693 - Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy Phase 3
Completed NCT00830700 - Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study N/A
Completed NCT00626236 - Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems Phase 2
Completed NCT01012622 - An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD) Phase 4
Completed NCT00598182 - Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study N/A
Completed NCT00381407 - Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder N/A
Completed NCT00178503 - Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children Phase 2/Phase 3
Completed NCT00247572 - Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories Phase 2
Completed NCT00218322 - Effectiveness of ATMX in Treating Adolescents With ADHD and SUD Phase 4
Completed NCT00557011 - NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD Phase 2
Completed NCT00118911 - Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder N/A
Completed NCT00071656 - Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I N/A
Active, not recruiting NCT00057668 - Preventing Behavior Problems in Children With ADHD Phase 2
Completed NCT00050622 - Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT00050050 - Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder Phase 1
Completed NCT00031395 - Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children Phase 3