NCT03906097

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

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

February 3, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.9 years

First QC Date

April 4, 2019

Last Update Submit

April 5, 2019

Conditions

Keywords

DyslexiaExecutive functionCognitive controlInhibitionWorking memoryPrefrontal Cortex

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (1)

  • Executive Functions and Occupational Routines Scale (EFORTS)

    This study pretest-posttest intervention and follow up (3 months) study was designed to assess the effects of the CBCT on children with dyslexia.

Study Arms (2)

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).

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).

Interventions

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

intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DyslexiaInhibition, Psychological

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD PT, Principal Investigator

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 8, 2019

Study Start

February 3, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

we have no plan to make individual participant data (IPD) available to other researchers.