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Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD

Primary Purpose

Central Auditory Processing Disorder, Dyslexia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

arabic version of differential processing training program

Arabic computer based auditory traing program(CBAT)

About this trial

This is an interventional treatment trial for Central Auditory Processing Disorder

Eligibility Criteria

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

Inclusion Criteria:

dyslexic children with (C)APD
Age from 6-12 years.
No gender limit.
Normal peripheral hearing i.e pure tone averages (average threshold from 250to 8000 Hz) should be less than or equal 25dB hearing level bilaterally.
Normal speech audiometry results.
Normal results on immitancemetry.
Average or below average IQ.
Normal language development.

Exclusion Criteria:

1. ADHD subjects. 2. Associated neurological and psychiatric disorders.

Sites / Locations

Alexandria university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Cases

control

Arm Description

cases will receive the proposed program(the arabic version of differential processing training program)

controls will receive the computer based auditory training program (CBAT)

Outcomes

Primary Outcome Measures

Effect on dichotic listening

assessed by screening and full version dichotic digits test pretherapy and post therapy

Effect on speech discrimination in noise.

assesed by screening and full version(auditory figure ground) SPIN test pretherapy and post therapy

Effect on temporal processing

assessed by screening and full version pitch pattern sequence test (PPST) pretherapy and post therapy

Secondary Outcome Measures

change in phonological processing and awareness skills

assessed by phonological awareness assessment pretherapy and post therapy

Full Information

NCT ID

NCT04708899

First Posted

January 12, 2021

Last Updated

February 1, 2023

Sponsor

Rana ElShafaei

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04708899

Brief Title

Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD

Official Title

Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(Central) Auditory Processing Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

March 20, 2022 (Actual)

Study Completion Date

March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rana ElShafaei

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Rehabilitation of dyslexic children with (cental) auditory processing disorder. The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT).

Detailed Description

Central Auditory Processing Disorder(C)APD is defined as difficulty for children with normal hearing to listen selectively in the presence of noise, to combine information from two ears properly, to process speech when it is slightly degraded, and to integrate auditory information when it is delivered faster than the individual with (C)APD can process.( The estimated prevalence of (C)APD in the school-aged population is approximately 2 to 5 %, and the estimated prevalence of (C)APD in the older adult population is 76 %. These percentages are higher than those affected by hearing loss. Dyslexia and (C)APD are common comorbidities and since there is limited research on (C)APD within each related academic discipline. Furthermore the language, audiologiological , and cognitive nature of the disorder confirmed that a multi-disciplinary effort is needed in order to provide clinical decision and effective intervention for the (C)APD population. Hence Development of additional intervention tools for use in clinics, schools and home settings is warranted . The aim of this work is to develop a novel Arabic (C)APD remediation program ,to study the outcome of the program and to validate it's effectiveness by comparing it to the Arabic computer based auditory training(CBAT) program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Auditory Processing Disorder, Dyslexia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cases

Arm Type

Active Comparator

Arm Description

cases will receive the proposed program(the arabic version of differential processing training program)

Arm Title

control

Arm Type

Active Comparator

Arm Description

controls will receive the computer based auditory training program (CBAT)

Intervention Type

Behavioral

Intervention Name(s)

arabic version of differential processing training program

Intervention Description

comprehensive training program for central auditory processing disorder contains auditory and linguistic tasks (language organization, phonemic and phonetic awareness, dichotic listening,temporal patterning and auditory discrimination).

Intervention Type

Behavioral

Intervention Name(s)

Arabic computer based auditory traing program(CBAT)

Intervention Description

comprehensive computer based traing program for central auditory processing disorder contains auditory memory, temporal processing, dichotic listening , selective attention and phonemic awareness games.

Primary Outcome Measure Information:

Title

Effect on dichotic listening

Description

assessed by screening and full version dichotic digits test pretherapy and post therapy

Time Frame

within 6 months

Title

Effect on speech discrimination in noise.

Description

assesed by screening and full version(auditory figure ground) SPIN test pretherapy and post therapy

Time Frame

Within 6 months

Title

Effect on temporal processing

Description

assessed by screening and full version pitch pattern sequence test (PPST) pretherapy and post therapy

Time Frame

within 6 months

Secondary Outcome Measure Information:

Title

change in phonological processing and awareness skills

Description

assessed by phonological awareness assessment pretherapy and post therapy

Time Frame

within 6month to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: dyslexic children with (C)APD Age from 6-12 years. No gender limit. Normal peripheral hearing i.e pure tone averages (average threshold from 250to 8000 Hz) should be less than or equal 25dB hearing level bilaterally. Normal speech audiometry results. Normal results on immitancemetry. Average or below average IQ. Normal language development. Exclusion Criteria: 1. ADHD subjects. 2. Associated neurological and psychiatric disorders. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hesham kozou, Professor

Organizational Affiliation

Alexandria University

Official's Role

Study Chair

Facility Information:

Facility Name

Alexandria university

City

Alexandria

State/Province

Azarita

ZIP/Postal Code

21311

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The IPD sharing is denied due to subject confidentially issues.

Learn more about this trial

Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD

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