DyslexiaNCT03906097
The Effects of Play and Competition-Based Cognitive Therapy
A study testing Play and Competition-Based Cognitive Therapy in people with Dyslexia and Executive Dysfunction, run by Hacettepe University.
Trial summary
Purpose: The aim of this study was to investigate the effects of play and competition-based cognitive therapy (PCB-CT) on executive function and occupational routines in children with dyslexia. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dyslexia, Executive Dysfunction
- What is being tested?
- Play and Competition-Based Cognitive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2014to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participants have only dyslexia diagnosis, They aged between 7-12 years and They have a 90 and above IQ score (normal IQ).
Who cannot join
- They have multiple conditions (neurological problems such as epilepsy) or primary psychiatric comorbidities (i.e. depression, anxiety, psychosis).
About this study
Official title: The Effects of Play and Competition-Based Cognitive Therapy on Executive Functions and Occupational Routines in Children With Dyslexia
Purpose: The aim of this study was to investigate the effects of play and competition-based cognitive therapy (PCB-CT) on executive function and occupational routines in children with dyslexia.
Method: In this randomized control trail, 64 children with dyslexia (between 7-12 ages) were randomly selected from the 162 clients who applied to the clinic. Children were divided randomly into a treatment group and a control group. Children in the intervention group was given cognitive therapy for 10 weeks, 3 days a week for one hour sessions while no therapy was received to the control group. In order to evaluate the cognition of the children Test of Visual Perceptual Skills-3 (TVPS-3) and Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch), to evaluate executive functions the Behavior Rating Inventory of Executive Function (BRIEF) and to evaluate occupational routine The Executive Functions and Occupational Routines Scale (EFORTS) were used. The evaluations were done at baseline, after treatment and the end of the 3rd month for both groups.
Read the detailed description
The participants included in this study if they had only dyslexia diagnosis, aged between 7-12 years and had a 90 and above IQ score (normal IQ), in addition didn't have multiple conditions (neurological problems such as epilepsy) or primary psychiatric comorbidities (i.e. depression, anxiety, psychosis).
Test of Visual Perceptual Scale-3(TVPS-3); The TVPS-3 was originally designed for children but the author Dr. Gardner also reported statistically significant differences between three groups diagnosed as having either developmental delay, head injury or learning disability. This test in its third edition has been revised by Martin for appropriate use in an adult population, with scores compared against the highest age group of scores (i.e. 18y 00-18y 11m) (Martin, 2006). There are seven subtests of eighteen stimuli figures each, which assess seven key areas of visual perception. Each subscale consisting of eighteen figures including two example items and sixteen test items are arranged in order of increasing complexity (see App. A). The test is largely an untimed instrument with the exception of subtests for visual memory and visual sequential memory being allocated a five second presentation time per item. Response time is however not restricted for any of the items.
The Dynamic Occupational Therapy Cognitive Assessment instrument designed to assess the cognitive abilities and learning potential of children from ages 6 to 12 years via a dynamic mediation testing process. DOTCA-Ch, a criterion-referenced assessment, was designed to fill this need. Originally based on the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), an assessment for adults with neuropsychological deficits, the DOTCA-Ch represents an adapted and modified format that is appropriate for use with school-age children. The DOTCA-Ch battery consists of 22 subtests in 5 cognitive domains: Orientation, Spatial Perception, Praxis, Visuomotor Construction, and Thinking Operations. Construct validity was supported by comparing children with traumatic brain injury and learning disabilities to typically developing children, and ecological validity of children with attention deficit hyperactivity disorder by comparing performance on the DOTCA-Ch to the School Function Assessment. Results of the intraclass correlation coefficients analysis revealed very high reliability coefficients for all cognitive domains, ranging from .87 to .99.
The Behavior Rating Inventory of Executive Function (BRIEF) assesses problem behaviors associated with executive function. The form consists of 86 brief descriptions of behavior problems, the frequency of which teachers and parents are asked to rate as occurring either never, sometimes, or often. Responses are aggregated to form eight subscales (Inhibit, shift, emotional control, initiate, working memory, plan/organize, organization of materials and monitor scale). Examples of test items from each subscale are shown in the Appendix C and D. T-scores are calculated for each measure. The scales showed high internal consistency on the BRIEF (a=.80-.90) for both Teachers and Parents form. The moderate test-retest reliabilities for teachers BRIEF (.90-.92) and for the parent BRIEF (.80-.83). Interrater reliability of the teachers BRIEF is reported as .17-.28, and of the parents BRIEF as .32-.34. Both tools are reported to have evidenced for content of the items, convergence and divergence of their scores with other measures.
- Conditions
- Dyslexia, Executive Dysfunction
- Being tested
- Play and Competition-Based Cognitive Therapy
- Keywords
- Dyslexia, Executive function, Cognitive control, Inhibition, Working memory, Prefrontal Cortex
- Medical subject headings
- Dyslexia, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play and Competition-Based Cognitive TherapyOther
The intervention group was received play and competition-based cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | SPSS 24.00 was randomized with the program and the control group was divided into 2 equal groups (intervention group n = 40; control group n = 40). The intervention group was received cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program (Figure 3.1). Both groups were evaluated three times at baseline, at the end of the 10th week and at the end of the third month (follow up). Receives: Other: Play and Competition-Based Cognitive Therapy |
| control | No intervention | SPSS 24.00 was randomized with the program and the control group was divided into 2 equal groups (intervention group n = 40; control group n = 40). The intervention group was received cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program (Figure 3.1). Both groups were evaluated three times at baseline, at the end of the 10th week and at the end of the third month (follow up). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Behavior Rating Inventory of Executive Function
The form consists of 86 brief descriptions of behavior problems, the frequency of which teachers and parents are asked to rate as occurring either never, sometimes, or often. Responses are aggregated to form eight subscales (Inhibit, shift, emotional control, initiate, working memory, plan/organize, organization of materials and monitor scale).
Measured: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
Test of Visual Perceptual Scale-3(TVPS-3);
The TVPS-3 was originally designed for children but the author Dr Gardner also reported statistically significant differences between three groups diagnosed as having either developmental delay, head injury or learning disability (Gardner, 1992). This test in its third edition has been revised by Martin for appropriate use in an adult population, with scores compared against the highest age group of scores (i.e. 18y00-18y11m)
Measured: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
The Dynamic Occupational Therapy Cognitive Assessment
It instrument designed to assess the cognitive abilities and learning potential of children from ages 6 to 12 years via a dynamic mediation testing process. DOTCA-Ch, a criterion-referenced assessment, was designed to fill this need. Originally based on the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), an assessment for adults with neuropsychological deficits, the DOTCA-Ch represents an adapted and modified format that is appropriate for use with school-age children. The DOTCA-Ch battery consists of 22 subtests in 5 cognitive domains
Measured: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the cognitive therapy on children with dyslexia.
Secondary outcomes (1)
Executive Functions and Occupational Routines Scale (EFORTS)
The EFORTS, in the context of executive functions, was used to evaluate the performance levels in their child's daily routines. The EFORTS can be used to determine whether executive function deficit in children regardless of the diagnosis. The tool was developed as a parent's report about the executive control through their child's daily routines. Three subscales in this survey were defined as follows: 1) morning and evening routines; 2) play and leisure; and 3) social routines. Each item was rated with a Likert scale as follows: never (1), seldom (2), sometimes (3), frequently (4) and always (5). The encoding of the EFORTS helped with obtaining means for each of the functional routine and a final functional score (mean). The accrual score evaluation was calculated by the mean, giving a score for both total and subscales. Higher score, in each executive controlled daily routine activity have shown the better performance of the child.
Measured: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start3 Feb 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before randomization, 80 children were performed the tests (TVPS-3 and DOTCA-Ch) and questionnaires (BRIEF and EFORTS) were given to their parents and teachers. Then, SPSS 24.00 was randomized with the program and the control group was divided into 2 equal groups (intervention group n = 40; control group n = 40). The intervention group was received cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program (Figure 3.1). Both groups were evaluated three times at baseline, at the end of the 10th week and at the end of the third month (follow up).
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokcen Akyurek, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906097
- Sponsor's protocol ID
- 16-375
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we have no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Play and Competition-Based Cognitive Therapy on Executive Functions and Occupational Routines in Children With Dyslexia
- ClinicalTrials.gov ID
- NCT03906097
- Acronym / sponsor ID
- 16-375
- Conditions
- Dyslexia, Executive Dysfunction
- Keywords
- Dyslexia, Executive function, Cognitive control, Inhibition, Working memory, Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Feb 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The aim of this study was to investigate the effects of play and competition-based cognitive therapy (PCB-CT) on executive function and occupational routines in children with dyslexia.
Method: In this randomized control trail, 64 children with dyslexia (between 7-12 ages) were randomly selected from the 162 clients who applied to the clinic. Children were divided randomly into a treatment group and a control group. Children in the intervention group was given cognitive therapy for 10 weeks, 3 days a week for one hour sessions while no therapy was received to the control group. In order to evaluate the cognition of the children Test of Visual Perceptual Skills-3 (TVPS-3) and Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch), to evaluate executive functions the Behavior Rating Inventory of Executive Function (BRIEF) and to evaluate occupational routine The Executive Functions and Occupational Routines Scale (EFORTS) were used. The evaluations were done at baseline, after treatment and the end of the 3rd month for both groups.
Detailed description
The participants included in this study if they had only dyslexia diagnosis, aged between 7-12 years and had a 90 and above IQ score (normal IQ), in addition didn't have multiple conditions (neurological problems such as epilepsy) or primary psychiatric comorbidities (i.e. depression, anxiety, psychosis).
Test of Visual Perceptual Scale-3(TVPS-3); The TVPS-3 was originally designed for children but the author Dr. Gardner also reported statistically significant differences between three groups diagnosed as having either developmental delay, head injury or learning disability. This test in its third edition has been revised by Martin for appropriate use in an adult population, with scores compared against the highest age group of scores (i.e. 18y 00-18y 11m) (Martin, 2006). There are seven subtests of eighteen stimuli figures each, which assess seven key areas of visual perception. Each subscale consisting of eighteen figures including two example items and sixteen test items are arranged in order of increasing complexity (see App. A). The test is largely an untimed instrument with the exception of subtests for visual memory and visual sequential memory being allocated a five second presentation time per item. Response time is however not restricted for any of the items.
The Dynamic Occupational Therapy Cognitive Assessment instrument designed to assess the cognitive abilities and learning potential of children from ages 6 to 12 years via a dynamic mediation testing process. DOTCA-Ch, a criterion-referenced assessment, was designed to fill this need. Originally based on the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), an assessment for adults with neuropsychological deficits, the DOTCA-Ch represents an adapted and modified format that is appropriate for use with school-age children. The DOTCA-Ch battery consists of 22 subtests in 5 cognitive domains: Orientation, Spatial Perception, Praxis, Visuomotor Construction, and Thinking Operations. Construct validity was supported by comparing children with traumatic brain injury and learning disabilities to typically developing children, and ecological validity of children with attention deficit hyperactivity disorder by comparing performance on the DOTCA-Ch to the School Function Assessment. Results of the intraclass correlation coefficients analysis revealed very high reliability coefficients for all cognitive domains, ranging from .87 to .99.
The Behavior Rating Inventory of Executive Function (BRIEF) assesses problem behaviors associated with executive function. The form consists of 86 brief descriptions of behavior problems, the frequency of which teachers and parents are asked to rate as occurring either never, sometimes, or often. Responses are aggregated to form eight subscales (Inhibit, shift, emotional control, initiate, working memory, plan/organize, organization of materials and monitor scale). Examples of test items from each subscale are shown in the Appendix C and D. T-scores are calculated for each measure. The scales showed high internal consistency on the BRIEF (a=.80-.90) for both Teachers and Parents form. The moderate test-retest reliabilities for teachers BRIEF (.90-.92) and for the parent BRIEF (.80-.83). Interrater reliability of the teachers BRIEF is reported as .17-.28, and of the parents BRIEF as .32-.34. Both tools are reported to have evidenced for content of the items, convergence and divergence of their scores with other measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before randomization, 80 children were performed the tests (TVPS-3 and DOTCA-Ch) and questionnaires (BRIEF and EFORTS) were given to their parents and teachers. Then, SPSS 24.00 was randomized with the program and the control group was divided into 2 equal groups (intervention group n = 40; control group n = 40). The intervention group was received cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program (Figure 3.1). Both groups were evaluated three times at baseline, at the end of the 10th week and at the end of the third month (follow up).
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Play and Competition-Based Cognitive TherapySPSS 24.00 was randomized with the program and the control group was divided into 2 equal groups (intervention group n = 40; control group n = 40). The intervention group was received cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program (Figure 3.1). Both groups were evaluated three times at baseline, at the end of the 10th week and at the end of the third month (follow up). |
| control | No intervention | –SPSS 24.00 was randomized with the program and the control group was divided into 2 equal groups (intervention group n = 40; control group n = 40). The intervention group was received cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program (Figure 3.1). Both groups were evaluated three times at baseline, at the end of the 10th week and at the end of the third month (follow up). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The participants have only dyslexia diagnosis, They aged between 7-12 years and They have a 90 and above IQ score (normal IQ).
Key exclusion criteria (1 listed)
- They have multiple conditions (neurological problems such as epilepsy) or primary psychiatric comorbidities (i.e. depression, anxiety, psychosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Play and Competition-Based Cognitive TherapyThe intervention group was received play and competition-based cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program | Other | intervention |
Primary outcome
The Behavior Rating Inventory of Executive Function
Time frame: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
The form consists of 86 brief descriptions of behavior problems, the frequency of which teachers and parents are asked to rate as occurring either never, sometimes, or often. Responses are aggregated to form eight subscales (Inhibit, shift, emotional control, initiate, working memory, plan/organize, organization of materials and monitor scale).
Test of Visual Perceptual Scale-3(TVPS-3);
Time frame: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
The TVPS-3 was originally designed for children but the author Dr Gardner also reported statistically significant differences between three groups diagnosed as having either developmental delay, head injury or learning disability (Gardner, 1992). This test in its third edition has been revised by Martin for appropriate use in an adult population, with scores compared against the highest age group of scores (i.e. 18y00-18y11m)
The Dynamic Occupational Therapy Cognitive Assessment
Time frame: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the cognitive therapy on children with dyslexia.
It instrument designed to assess the cognitive abilities and learning potential of children from ages 6 to 12 years via a dynamic mediation testing process. DOTCA-Ch, a criterion-referenced assessment, was designed to fill this need. Originally based on the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), an assessment for adults with neuropsychological deficits, the DOTCA-Ch represents an adapted and modified format that is appropriate for use with school-age children. The DOTCA-Ch battery consists of 22 subtests in 5 cognitive domains
1 secondary outcome
Executive Functions and Occupational Routines Scale (EFORTS)
Time frame: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No. we have no plan to make individual participant data (IPD) available to other researchers.
Related trials for Dyslexia
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Play and Competition-Based Cognitive Therapy in people with Dyslexia and Executive Dysfunction, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Behavior Rating Inventory of Executive Function (time frame: This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.