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Cognitive Intervention in Attention Deficit and Hyperactivity Disorder

Primary Purpose

ADHD, Cognitive Deficit

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive Occupational Therapy
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring Attention Deficit and Hyperactivity Disorder, Executive functions, Occupational therapy

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any medical or mental health problems
  • Any secondary diagnosis

Sites / Locations

  • Biruni University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Occupational Therapy

Control

Arm Description

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.

No intervention was performed in this group.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2021
Last Updated
September 30, 2021
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05063669
Brief Title
Cognitive Intervention in Attention Deficit and Hyperactivity Disorder
Official Title
Effects of Cognitive Occupational Therapy Interventions on Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or growing. In individuals with ADHD, clinical findings may vary depending on development. It is frequently observed that ADHD, which has a progressive character, continues into adulthood after childhood and adolescence. The study was conducted in Biruni University Occupational Therapy Unit. Since the individuals participating in the study were under the age of 18, an informed consent form was signed by their parents. The research was carried out between June and December 2020. The study included children aged 9-12 years who were diagnosed with ADHD according to DSM-V criteria by a psychiatrist, did not use any medication for ADHD, or were given a fixed dose 3 months ago and did not plan to change their treatment. Children who could not participate in the study because of any medical or mental health problems and who were diagnosed with any secondary diagnosis were excluded. First of all, the sociodemographic form was applied to the participants. The form consisted of questions to determine age, gender, disease history, presence of drugs used continuously, education level of parents, and whether the participant or family member had neurological or psychiatric disorders. Stroop Test T Bag Form (ST-TBAG), The Children's Color Trails Test (CCTT) and Verbal Fluency Test (VFT) were applied to all participants before and after intervention. 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. Research data were evaluated in SPSS 22.0 package program. Mean±standard deviation (X±SD) was determined for the variables determined by measurement. The Wilcoxon Paired Two-Sample Test was used to compare the first and last evaluation data of the intervention and control groups and the Mann Whitney-U test was used to compare the demographic and initial evaluation data of both groups. A significance value of p<0.05 was accepted in all statistical analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Cognitive Deficit
Keywords
Attention Deficit and Hyperactivity Disorder, Executive functions, Occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Occupational Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention was performed in this group.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Occupational Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroop Test T Bag Form
Description
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.
Time Frame
2 weeks
Title
The Children's Color Trails Test
Description
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.
Time Frame
2 weeks
Title
Verbal Fluency Test
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Any medical or mental health problems Any secondary diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remziye Akarsu, MS
Organizational Affiliation
Biruni University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Başar Öztürk, PhD
Organizational Affiliation
Biruni University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amine Karademir, Bachelor
Organizational Affiliation
Biruni University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Melek Görgülü, Bachelor
Organizational Affiliation
Biruni University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Betül Güler, Bachelor
Organizational Affiliation
Biruni University
Official's Role
Study Chair
Facility Information:
Facility Name
Biruni University
City
İstanbul
ZIP/Postal Code
34020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Intervention in Attention Deficit and Hyperactivity Disorder

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