NCT06927583

Brief Summary

Autism spectrum disorder (ASD) is considered one of the commonest developmental disabilities, characterized mainly by impairments in social performance and communicative skills, repetitive stereotypical behaviors, and restriction in interests and activities, with a combination of sensory, cognitive, behavioral, and communication features which persist throughout life. Caminha \& Lampreia specified that there is a significantly high prevalence of sensory processing dysfunctions in ASD. Sensory processing means how the central and peripheral nervous systems deal with the incoming sensory input from different sensory organs; visual, auditory, smell, taste, tactile, proprioception, and vestibular information. Sensory processing dysfunction is the neurological dysfunction affecting the adequate reception, modulation, integration, discrimination, or organization of sensory stimuli, and the behavioral responses to the sensory input. Sensory integration therapy (SIT) is a frequent type of therapy that aims to improve a child's ability to perceive and integrate sensory input in order to explore more ordered and appropriate actions. SIT improves motor skills, social relationships, attention, behavior control, language and pre-linguistic communicative abilities, reading comprehension, participation in play activities, and personal identification. Therefore, the need for further explicit assessment of sensory integration intervention among ASD children has been increased to identify its gains in social and verbal interactions. This study aimed to estimate the impact of sensory integration therapy on language development in autism spectrum disorder children.46 ASD children will enroll in this study, their ages ranged from 3-10 years, males and females, divided into two groups (group I received speech therapy sessions together with sensory integration therapy sessions, group II received speech therapy sessions only) went through two stages of evaluation before and after receiving their sessions with one year apart. All children were subjected to Childhood Autism Rating Scale (CARS), sensory profile assessment by Short Sensory profile (SSP) and Assessment of Basic Language and Learning Skills- Revised (The ABLLS-R).Data will be taken from Clinics and Schools having children with autism

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 Mar 2025

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

April 7, 2025

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of Basic Language and Learning Skills- Revised (ABLLS-R)

    The ABLLS-R scoring system evaluates a child's skills across 25 developmental areas. Each task within a skill area is broken into steps, scored on a 0-2 scale: 0 for no skill, 1 for emerging or assisted performance, and 2 for independent mastery. The scores for all steps in a task are totaled to give a task score, which contributes to the overall skill area score. A visual tracking grid is used to record and color-code performance, helping identify strengths, areas for improvement, and track progress over time. This scoring guides individualized goal setting and intervention planning.

    baseline and 6 weeks

Study Arms (2)

Sensory integration therapy

EXPERIMENTAL

Experimental group was given sensory integration therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes.

Other: sensory integration therapy

Traditional Speech therapy

ACTIVE COMPARATOR

Control group was given traditional speech therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes.

Other: Traditional Speech therapy

Interventions

sensory integration therapy include 2 categories that comprised of 9 strategies.

Also known as: Traditional speech therapy
Sensory integration therapy

Control group was given traditional speech therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes.

Traditional Speech therapy

Eligibility Criteria

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

You may qualify if:

  • Pre diagnosed autistic children
  • Both male and female
  • Age range:3 years to 10 years
  • Moderately severe

You may not qualify if:

  • \- Autism with any comorbid will be excluded ( hearing impaired, Any syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayyati Clinic

Lahore, Punjab Province, 54500, Pakistan

Location

Related Publications (2)

  • Barros VdM, Folha DRdSC, Pinheiro RC, Della Barba PCdSJCBdTO. Sensory processing and engagement: a systematic review. 2023;31:e3521.

    BACKGROUND
  • Randell E, Wright M, Milosevic S, Gillespie D, Brookes-Howell L, Busse-Morris M, Hastings R, Maboshe W, Williams-Thomas R, Mills L, Romeo R, Yaziji N, McKigney AM, Ahuja A, Warren G, Glarou E, Delport S, McNamara R. Sensory integration therapy for children with autism and sensory processing difficulties: the SenITA RCT. Health Technol Assess. 2022 Jun;26(29):1-140. doi: 10.3310/TQGE0020.

    PMID: 35766242BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hina Omer, Ms(SLP)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 15, 2025

Study Start

March 17, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations