NCT04494230

Brief Summary

In this study, aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department between October 1, 2018 - October 1, 2019 were included in the research group.As for the control group, boys between 6-10 years of age with no mental symptoms described by their teachers or parents and showing healthy development were selected by convenience sampling method and snow ball method. Height and weight measurements of all the children participated in the study were performed. The sociodemographic data form prepared by the researchers was completed by both the research and the control group families. In the sample, the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms.The hand preferences of all participants in the research and control groups were evaluated with Edinburgh Handedness Inventory.Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2).Hand skills were evaluated with the 9-Hole Peg Test.Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). Pediatric Quality of Life Inventory Parent Form were filled by the parents of children in the research and control groups for quality of life. In the study, there are five groups: ADHD, ADHD + Specific learning disorders, ADHD + Oppositional defiant disorder, ADHD + Anxiety Disorder and children with typical development group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
Last Updated

July 31, 2020

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

July 28, 2020

Last Update Submit

July 28, 2020

Conditions

Keywords

Attention Deficit Hyperactivity Disordercomorbiditymotor skills

Outcome Measures

Primary Outcomes (5)

  • severity ADHD symptoms

    the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms. The scale whose Turkish adaptation study was made by Kaner et al. (2006) consists of 27 items. In CPS-R:SF, questions are answered on a 4-point Likert scale and high scores indicate the intensity of symptoms.

    10 minutes

  • motor profiency

    Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2) (Bruininks, 1978). It is a standard test commonly used by physiotherapists to detect coarse and fine motor problems in children aged 4-21 years. It has both short and long form. The short form was used in our study. The short form of BOT-2 consists of 8 subtests: fine motor precision, fine motor integration, manual dexterity, bilateral coordination, balance, speed of movement and agility, upper extremity coordination and strength. Not only can the score of each subtest of the test be calculated separately but it can also be calculated as fine motor skill, gross motor skill, both fine and gross motor skill and total motor skill score.

    40-45 minutes

  • hand skills

    Hand skills were evaluated with the 9-Hole Peg Test. This questionnaire questions a hand or both hands used in daily life activities such as writing, drawing, ball throwing, using scissors, using a toothbrush, using a fork-free knife, using a spoon, sweeping with a broom handle, burning matches and opening boxes

    10 minutes

  • visual perception

    Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). MVPT-3 is a fast, reliable test that tests visual perception without motor skills in children and adults (ages 4-65). The test consists of 65 questions and the first 40 questions were developed to test school-age children in terms of visual perception without motor skills as follows: visual discrimination (1-8), form constancy (9-13), visual memory-I (14-21), visual closure (22-34), visual differentiation (35-40). Total visual perception score and scores from each category were calculated separately

    30 minutes

  • quality of life

    Quality of life were evaluated with Pediatric Quality of Life Inventory (PedsQL) aims to measure the overall quality of life in the 2-18 age group. The scale has separate parent and child forms for the groups of 5-7 years, 8-12 years and 13-18 years. Scoring of the scale is done in 3 areas. Firstly, scale total score (STS) is calculated, and secondly, physical health total score (PHTS) is calculated. Thirdly, psychosocial health total score (PHTS) is calculated, which consists of calculating item scores evaluating emotional, social and school functionality. The higher the total score of the scale is, the better the quality of life related to health is perceived

    15-20 minutes

Study Arms (5)

Attention deficit hyperactivity disorder (ADHD) only

the diagnosis of ADHD

Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities

Attention deficit hyperactivity disorder (ADHD) andSpecificand

the diagnosis of ADHD and SLD

Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities

ADHD and oppositional defiant disorder (ODD)

the diagnosis of ADHD and ODD

Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities

ADHD and Anxiety Disorder

the diagnosis of ADHD and Ank. Dis.

Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities

Typical Development Children

no mental symptoms described by their teachers or parents and showing healthy development

Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities

Interventions

to investigate whether motor skills, manual dexterity and visual perception differ in the presence of ADHD and comorbid psychiatric conditions in school-age boys by comparing them typical development children.

ADHD and Anxiety DisorderADHD and oppositional defiant disorder (ODD)Attention deficit hyperactivity disorder (ADHD) andSpecificandAttention deficit hyperactivity disorder (ADHD) onlyTypical Development Children

Eligibility Criteria

Age6 Years - 10 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsschool-aged male children
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children aged 6-10 years, male, right hand dominant

You may qualify if:

  • children aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department

You may not qualify if:

  • with head trauma or known neurological disease, clinically diagnosed as comorbid tic disorder, obsessive-compulsive disorder, psychotic disorder, mood disorder, conduct disorder, mental retardation, or autism spectrum disorder, or children previously excluded from physical therapy program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Goulardins JB, Marques JC, De Oliveira JA. Attention Deficit Hyperactivity Disorder and Motor Impairment. Percept Mot Skills. 2017 Apr;124(2):425-440. doi: 10.1177/0031512517690607. Epub 2017 Jan 31.

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMotor Skills Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nilay Şahan, PhD,PT

    unaffilliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hacettepe University

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

July 31, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations