NCT06882642

Brief Summary

The objective of this study is to determine the effects of therapy in sensory rooms with multisensory environment on the severity of autism spectrum disorder and stereotyped and repetitive behaviours in a sample of Egyptian children with autism spectrum disorder

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

February 27, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of sensory integration therapy

    Effect of sensory integration therapy on autism spectrum disorder symptoms and signs and severity. The sessions are held weekly for 12 weeks, lasting half an hour, and the measurement is done before and after them, taking an hour. The sensory integration program lasts 12 weeks with 12 sessions, each 30 minutes. Participants must attend at least 9 sessions. Afterward, they will be reassessed using CARS and the Sensory Profile Caregiver questionnaire. The sensory room provides multisensory stimulation through tools like projectors, fibre optics, and auditory devices.

    12 weeks

Study Arms (1)

Sensory integration therapy

EXPERIMENTAL

Autistic patients will undergo sensory integration therapy

Procedure: Sensory integration therapy

Interventions

Autistic patients will undergo sensory integration therapy

Sensory integration therapy

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients included in the study are diagnosed with Autism spectrum disorder according to DSM-V criteria.
  • Participants have to have a sensory problem in their diagnostic criteria.
  • Age ranges between 3-10 years. (as scope of the study is focused on children)
  • Both males and females.
  • Parents or guardian agreed to informed consent.

You may not qualify if:

  • Parents refusing to participate in the research
  • Children with comorbid psychiatric and/or neurological disorder
  • Children with co-morbid sensory deficit, hearing , vision, and motor deficit
  • Intelligence quotient level below 60
  • Children who scored typical performance in the sensory profile care-giver questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Neurology and Psychiatry, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 18, 2025

Study Start

May 1, 2023

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Locations