NCT05125120

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

October 24, 2021

Last Update Submit

November 7, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • The Canadian Occupational Performance Measure (COPM)

    It is an client-centred semi-structured interview method in which individuals score their performance and satisfaction in the activities that they need, want, or are required to accomplish in the areas of self-care, productivity, and leisure (17, 18). On a 10-point scale (1=not able to do=not satisfied at all, 10=can be done=pleased), the individual ranks the activities that he or she considers significant for themselves separately in terms of performance and satisfaction

    five weeks

  • Goal Attainment Scaling (GAS)

    It is used to determine whether children have met their functional activity goals. It's critical that the objectives are clear, measurable, and well-timed (21, 22). The various achievable results for each aim are defined independently at five levels while scoring the GAS: -2, -1, 0, +1, and +2. The initial level is -2, and the child's level is re-evaluated after the application

    five weeks

  • The Bruininks-Oseretsky Test of Motor Proficiency and Performance-Short Form (BOTMP-SF)

    The BOTMP-SF which was modified from the long version and is used to assess children's motor abilities, has 14 items and a maximum score of 98. BOTMP-SF assesses upper extremity coordination, balance, visual-motor control, and other skills in three areas: gross motor, gross-fine motor, and fine motor

    five weeks

  • The Executive Functions and Occupational Routines Scale (EFORTS)

    This scale is used to assess executive function skills and activity routines of children aged 6-12 years, including impulsivity, verbal and nonverbal memory, self-regulation, planning, and problem-solving. It is divided into three sections: morning-evening routine, game-entertainment routines, and social routines

    five weeks

  • Visual Analogue Scale (VAS)

    The VAS is a scale for converting some values that are difficult to measure numerically into numerical data. The participant uses a vertical line on a 0-10 cm scale to denote his or her emotional state, and the distance is measured with a ruler. The VAS was used to measure the level of satisfaction of families with therapy in this study.

    five weeks

Study Arms (1)

Attention Deficit and Hyperactivity Disorder

OTHER

Attention Deficit and Hyperactivity Disorder (CO-OP Group) Attention Deficit and Hyperactivity Disorder (Control Group)

Other: COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACH

Interventions

Polatajko et al. (2001) developed the CO-OP approach, which is an occupation-oriented problem-solving approach that combines cognitive strategies to help children acquire motor abilities throughout daily tasks (9, 29). The CO-OP approach of therapy focuses on the goal or task at hand rather than the acquisition of functions in occupational performance. CO-OP is a 'deductive' or 'occupational performance-oriented' approach that focuses on the activity target selected throughout the therapy, as opposed to 'inductive' or 'impairment-focused' alternatives (13). As a verbal approach, CO-OP focuses on skill acquisition at the activity level and strives to provide children with global problem-solving skills. Necessary performance strategies specific to the child and the activity are determined with a customised programme (12, 30). Skill acquisition, cognitive strategy development, and adapting and transferring these acquired skills to daily life are the three key goals of the approach.

Attention Deficit and Hyperactivity Disorder

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar State Hospital

Afyonkarahisar, Turkey (Türkiye)

Location

Related Publications (1)

  • Gurlek S, Bumin G. The effect of cognitive orientation to daily occupational performance in children with attention deficit hyperactivity disorder: A pilot randomized controlled study. Appl Neuropsychol Child. 2024 Jul 31:1-10. doi: 10.1080/21622965.2024.2385679. Online ahead of print.

MeSH Terms

Conditions

Orientation, SpatialMotor Activity

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SEDANUR GÜRLEK (Master's degree)(Occupational Therapist)

Study Record Dates

First Submitted

October 24, 2021

First Posted

November 18, 2021

Study Start

March 1, 2020

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations