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The Effects of Play and Competition-Based Cognitive Therapy

Primary Purpose

Dyslexia, Executive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Play and Competition-Based Cognitive Therapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia focused on measuring Dyslexia, Executive function, Cognitive control, Inhibition, Working memory, Prefrontal Cortex

Eligibility Criteria

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

Inclusion Criteria:

The participants have only dyslexia diagnosis, They aged between 7-12 years and They have a 90 and above IQ score (normal IQ).

Exclusion Criteria:

They have multiple conditions (neurological problems such as epilepsy) or primary psychiatric comorbidities (i.e. depression, anxiety, psychosis).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention

    control

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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).
    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)
    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 4, 2019
    Last Updated
    April 5, 2019
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03906097
    Brief Title
    The Effects of Play and Competition-Based Cognitive Therapy
    Official Title
    The Effects of Play and Competition-Based Cognitive Therapy on Executive Functions and Occupational Routines in Children With Dyslexia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 3, 2014 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 1, 2019 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslexia, Executive Dysfunction
    Keywords
    Dyslexia, Executive function, Cognitive control, Inhibition, Working memory, Prefrontal Cortex

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention
    Arm Type
    Experimental
    Arm Description
    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 Title
    control
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Play and Competition-Based Cognitive Therapy
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    The Behavior Rating Inventory of Executive Function
    Description
    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).
    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.
    Title
    Test of Visual Perceptual Scale-3(TVPS-3);
    Description
    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)
    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.
    Title
    The Dynamic Occupational Therapy Cognitive Assessment
    Description
    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
    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.
    Secondary Outcome Measure Information:
    Title
    Executive Functions and Occupational Routines Scale (EFORTS)
    Description
    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.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The participants have only dyslexia diagnosis, They aged between 7-12 years and They have a 90 and above IQ score (normal IQ). Exclusion Criteria: They have multiple conditions (neurological problems such as epilepsy) or primary psychiatric comorbidities (i.e. depression, anxiety, psychosis).

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    we have no plan to make individual participant data (IPD) available to other researchers.

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    The Effects of Play and Competition-Based Cognitive Therapy

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