Clinical trial NCT05125120: THE EFFECT OF THE COGNITIVE ORIENTATION TO DAILY OCCUPATIONAL PERFORMANCE (CO-OP) APPROACH IN CHILDREN WITH ATTENTION DEFICIT AND HYPERACTIVITY DISORDER ON MOTOR PERFORMANCE AND EXECUTIVE FUNCTIONS
Official title: THE EFFECT OF THE COGNITIVE ORIENTATION TO DAILY OCCUPATIONAL PERFORMANCE (CO-OP) APPROACH IN CHILDREN WITH ATTENTION DEFICIT AND HYPERACTIVITY DISORDER ON MOTOR PERFORMANCE AND EXECUTIVE FUNCTIONS: A RANDOMIZED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Orientation
Executive Dysfunction
Motor Activity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Attention deficit and hyperactivity disorder (ADHD) is a behavioural and neurodevelopmental disorder that can affect behavioural, emotional, academic, social, and cognitive functions and is not age-appropriate. The prevalence of ADHD among school children is reported to be 3%-11%. Children with ADHD have difficulties paying attention to details, concentrating, completing tasks and following instructions, among other social and academic challenges. In children with ADHD, insufficient activity in the prefrontal regions of the brain has been evidenced, which is linked to executive function skills. Such children have difficulties in performing executive functions that require a high level of cognitive skills, such as self-control and regulation, as well as sequencing and planning tasks. The Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) addresses executive dysfunction as a characteristic of ADHD. At the same time, 45%-70% of these children show problems in motor skills. Motor problems associated with ADHD, such as manual dexterity, bilateral coordination, and postural balance, can lead to difficulty in everyday living tasks, such as eating and writing, as well as social adaptability, academic skills, and peer interactions. For this reason, motor skill problems along with symptoms of inattention, hyperactivity, and impulsivity, should be addressed as part of the treatment strategy. ADHD has an impact on a child's independence for daily activities. As a result, child-specific occupational therapy approaches are critical for the sensory, motor, and cognitive areas that affect children's occupational performance in basic and instrumental activities of daily living, participation, rest and sleep, play, and leisure.

Detailed description: Afyonkarahisar University of Health Sciences Non-Invasive Clinical Research Ethics Committee evaluated the study with the 2011-KAEK-2 ethics committee code. The study was planned to be carried out in Afyonkarahisar State Hospital Occupational Therapy Unit. It was planned to include 30 children between the ages of 7 and 12 who were diagnosed with ADHD according to the DSM-5 criteria by a child psychiatrist. Children will be randomly divided into two groups: 15 in the intervention group and 15 in the control group. At the beginning of the study, the purpose of the study will be explained to the family and the child and informed consent forms will be signed. Standard tests will be applied after the sociodemographic information of the child and his family is obtained. With the CO-OP approach, the intervention group will receive two sessions of therapy per week, each for approximately one hour, for a total of 6 weeks and 12 sessions. After 6 weeks, standard assessments will be repeated. The control group will receive the same standardized assessments at baseline and 6 weeks later with no further intervention.

Eligibility criteria: Inclusion criteria:

* The child is between 7 and 12 years old
* Meeting the diagnostic criteria for ADHD
* Continuing drug therapy with methylphenidate
* Attending school

Exclusion Criteria:

* Having a mental, chronic neurological or orthopedic disorder in addition to ADHD

Primary outcomes:
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: five weeks
measure: Goal Attainment Scaling (GAS)
timeFrame: five weeks
measure: The Bruininks-Oseretsky Test of Motor Proficiency and Performance-Short Form (BOTMP-SF)
timeFrame: five weeks
measure: The Executive Functions and Occupational Routines Scale (EFORTS)
timeFrame: five weeks
measure: Visual Analogue Scale (VAS)
timeFrame: five weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar State Hospital
Study officials:
References: