Therapy Program for Academic Skills in Children With Inte... | NCT05900830

Studies
Therapy Program for Academic Skills in Children With Intellectual Disability

NCT05900830

Sponsor

Beni-Suef University

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Intellectual Disability, Mild
Educational Problems

Interventions

play therapy
common educational methods

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2022Actual

Primary Completion Date

Jan 30, 2023Actual

Completion Date

Feb 5, 2023Actual

First Submitted Date

Feb 10, 2023

First Submission Date that Met QC Criteria

Jun 9, 2023

First Posted Date

Jun 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2024

Last Update Posted Date

Nov 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tayseer Saber Abdeldayem, Lecturer, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate the effect of a physical and occupational therapy program on academic skills in a sample of Egyptian children with intellectual disability. It also aims to provide a program based on physical and occupational therapy activities and techniques to develop children's basic abilities through play to make learning more enjoyable

Detailed Description

This study hypothesis

There are statistically significant differences between the mean scores of the children of the experimental group in the pre and post measurements on the academic skills scale for children with mental disabilities and its sub-components in favor of the post measurement.
There are no statistically significant differences between the mean scores of the children of the experimental group in the post and follow-up measurements on the academic skills scale for children with mental disabilities and its sub-components.

RESEARCH QUESTION:

What is the effect of a physical and occupational therapy program in improving academic skills (reading - writing - arithmetic) in a sample of children with mild intellectual disabilities? The study should include 20 children diagnosed with mild intellectual disability according to Stanford Binet scale 5th edition between the age of 8 to 10 years old from both sexes recruited from Noor Al-Sabah Association for the Care and Rehabilitation of People with Intellectual Disabilities from children with mild mental disabilities

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
common educational methods	Active Comparator	this group will receive common educational methods	Other: common educational methods
play based program	Experimental	this group will get the combined selected physical and occupational therapy program	Other: play therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
play therapy	Other	A combined program based on physical and occupational therapy techniques within a play context	play based program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Academic Skills Scale for Children with Mild Intellectual Disabilities.	Reading and writing words, reading and writing simple sentences, knowledge of reading phenomena, comprehension., Reading, reading expression, reading and writing numbers and numbers, order and sequence, classification, relationships, arithmetic operations	2 months

Secondary Outcomes

Measure	Description	Time Frame
The Stanford-Binet Scale, the fifth edition	the Stanford-Binet Intelligence Scale Fifth Edition	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The child should be between 8 and 10 years of age of both sexes
The child should be of mild intellectual disabilities according to Stanford Binet scale 5th edition
The child should not be suffering from any apparent physical deformity in upper limbs, lower limbs or spine
The child should not suffer from any visual or auditory disorder

Exclusion Criteria:

Children out of age range
Children with moderate or severe intellectual disabilities
Children with physical deformities in upper limb, lower limb or spine
Children suffering from visual or auditory disorders
Children of parents who refuse to sign the consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zienab M Mahmoud, PhD	Beni-Suef University	Study Chair
Nahed MG Makary, PhD	Beni-Suef University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tayseer Younes		Cairo	Cairo Governorate	11411	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

no personal data will be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008607	Intellectual Disability
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010989	Play Therapy
D012149	Restraint, Physical

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided