Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD
NCT05718427, Not applicable, Completed, Hacettepe University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD | ClinicalTrials.gov |
| NCT number | NCT05718427 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 94 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Hacettepe University | ClinicalTrials.gov |
| Conditions | Attention Deficit Disorder With Hyperactivity, Sensory Integration Disorder, Motor Activity, Cognitive Deficit in Attention, Behavior Hyperactive, Emotional Regulation, Social Skills | ClinicalTrials.gov |
| Interventions | Ayres Sensory Integration Therapy | ClinicalTrials.gov |
| First posted | 2023-02-08 | ClinicalTrials.gov |
| Last updated | 2024-10-02 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Sensory Integration and Praxis Test (SIPT) | 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. | 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. | ClinicalTrials.gov |
| Primary | Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) | 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. | 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. | ClinicalTrials.gov |
| Primary | Goal Attainment Scale (GAS) | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | The Emotional Regulation Checklist (ERC) is a 24-item scale developed by Shields and Cicchetti to evaluate the emotion regulation competence of children aged 6-13 and can be evaluated by both parents and teachers. | ClinicalTrials.gov |
| Secondary | 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. | Childhood Executive Functions Inventory (CHEXI) is a scale consisting of 26 questions for children aged 4-12 years, developed by Lisa B. Thorell and Lilianne Nyberg as a measurement focusing especially on executive functions. | ClinicalTrials.gov |
| Secondary | 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. | The Participation and Environment Scale for Children and Youth (PEM-CY) is a 28-item questionnaire assessing participation in children aged 5-17 years. It is a family-reported scale that questions the child's participation in school, home and society. | ClinicalTrials.gov |
| Secondary | 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. | The Stroop Test TBAG Form (Stroop TBAG) is one of the golden tests used to measure selective attention and ability to shift attention, focusing on the color used in the spelling of the word and the disruptive effect of the color in the pronunciation of the word. | ClinicalTrials.gov |
| Other | 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. | The Sensory Profile (SP) is a family-reported scale that provides data on children's reactions to sensory events in daily life, how sensory behaviors can contribute to performance in daily life, and what difficulties they cause in performance. It consists of 125 questions that can be applied between the ages of 3-10. | ClinicalTrials.gov |
| Other | 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 Parent Rating Scale (CPRS) is important behavioral screening and diagnostic scales that have a wide range between the ages of 3-17 and are used quite frequently especially in ADHD. CPRS consists of 48 items developed to child behavior. | ClinicalTrials.gov |
| Other | 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. | Conners Teacher Rating Scale (CTRS) is important behavioral screening and diagnostic scales that have a wide range between the ages of 3-17 and are used quite frequently especially in ADHD. CTRS consists of 28 items developed to grade students' classroom behaviors by their teachers. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)