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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03906097
Other study ID # 16-375
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2014
Est. completion date January 1, 2019

Study information

Verified date April 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 1, 2019
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Play and Competition-Based Cognitive Therapy
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Outcome

Type Measure Description Time frame Safety issue
Primary 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). This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
Primary 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) This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
Primary 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 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 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. This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.
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