NCT05063669

Brief Summary

Attention Deficit Hyperactivity Disorder is a disorder in which children show insufficient attention span, hyperactivity and impulsivity according to their developmental level. It is stated that in the absence of rehabilitation, the child's social and academic functionality gradually deteriorates, there are problems in cognitive function processes and executive dysfunctions that affect daily life. The aim of this study was to investigate the effects of cognitive occupational therapy interventions on executive functions in children with Attention Deficit and Hyperactivity Disorder. 21 children aged 9-12 years were included in the research (10 study group-11 control group). One individual and one group session was applied to the study group at Biruni University Occupational Therapy Unit as 2 times per week for 8 weeks. Both groups were evaluated at the beginning and after 8 weeks with Children's Color Trails Test, Verbal Fluency Test and Stroop Test T-Bag Form. Wilcoxon Paired Sample Test and Mann Whitney U Test were used for analysis of intervention results and comparison between groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 15, 2021

Last Update Submit

September 30, 2021

Conditions

Keywords

Attention Deficit and Hyperactivity DisorderExecutive functionsOccupational therapy

Outcome Measures

Primary Outcomes (3)

  • Stroop Test T Bag Form

    Stroop Test T Bag Form evaluates selective or focused attention and is administered with four 14x21.5 cm white cards. On the first card, random color names (blue, green, red, yellow) are printed in black letters, in a total of 10 rows with five words per line. The second card has the same number of dots printed with these colors, the third card has the same number of color names with the colors written (each written color name is printed in a different color), the fourth card has random words written in different colors.14 Participants were first asked to read the black printed card as fast as possible. The errors and corrections made during this period and the total time spent were recorded. Color names written in color in the second stage, the colors of the shapes in the third stage, word colors without color names in the fourth stage and in the fifth stage, the test was completed by recording the accuracy and duration of saying the word colors, which are the color names.

    2 weeks

  • The Children's Color Trails Test

    The Children's Color Trails Test was used as a measure in which the first part measures psychomotor speed and the second part evaluates executive function and visuospatial working memory, reflecting the ability to change strategy.

    2 weeks

  • Verbal Fluency Test

    Verbal Fluency Test VFT is a short screening test that evaluates cognitive function. The two most commonly used variations of the test focus on semantic and phonemic criteria.13 In the first, words in the same semantic field are requested (for example, animals), in the second, it is requested to evoke as many words with the same phoneme as possible (for example, words starting with /a/). One minute was determined for each letter (the letter B is given as an example) and the participant was asked to say every word that can be remembered, provided that there were no proper names starting with the letters K, A and S. Then they were asked to count the fruits, animals and products that could be bought in the supermarket, again for one minute per category and the results were recorded.

    2 weeks

Study Arms (2)

Cognitive Occupational Therapy

EXPERIMENTAL

Occupational therapy applications were carried out 40 minutes, twice a week (one individual session and one group intervention session) and total of 8 weeks. In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills.

Behavioral: Cognitive Occupational Therapy

Control

NO INTERVENTION

No intervention was performed in this group.

Interventions

In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills.

Cognitive Occupational Therapy

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 9-12 years
  • Clinical diagnosis of ADHD according to DSM-V criteria by a psychiatrist
  • Not taking any medication for ADHD or taking a fixed dose 3 months ago

You may not qualify if:

  • Any medical or mental health problems
  • Any secondary diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityCognition Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeurocognitive Disorders

Study Officials

  • Remziye Akarsu, MS

    Biruni University

    PRINCIPAL INVESTIGATOR
  • Başar Öztürk, PhD

    Biruni University

    STUDY DIRECTOR
  • Amine Karademir, Bachelor

    Biruni University

    STUDY CHAIR
  • Melek Görgülü, Bachelor

    Biruni University

    STUDY CHAIR
  • Betül Güler, Bachelor

    Biruni University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 1, 2021

Study Start

June 15, 2020

Primary Completion

September 20, 2020

Study Completion

December 30, 2020

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations