NCT07428876

Brief Summary

The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5\_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT) . Outcome to be measure and analyze will be repetitive behavior, communication, social interaction and motor skills. Tools used for data collection are REPETITIVE BEHAVIOUR QUESTIONNAIRE (RBQ-2). Gallium autism rating scale (GARS) second edition. Data will be analyzed through the SPSS version 23:00

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 22, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

November 18, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

Autism spectrum disorder (ASD)Sensory Integrated Therapy (SIT).

Outcome Measures

Primary Outcomes (2)

  • REPETITIVE BEHAVIOUR QUESTIONNAIRE

    The Repetitive Behaviour Questionnaire is a questionnaire designed to measure repetitive behaviour .It has two versions.it has total value 0-20

    baseline, 1st week and 4th week

  • THE GILLIAM AUTISM RATING SCALE ,second edition

    The Gallium autism ratind scale is a Autism screening tool developed by Dr. James E. Gilliam to serve as a practical piece of early childhood developmental screenings when teachers, parents and other people who observe children are worried that the child might have Autism.it has 3 main parts 0-42 value.

    baseline, 1st week and 4th week

Study Arms (1)

experimental group

EXPERIMENTAL

experrimental group. This intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins.

Other: sensory integrated therapy exercises

Interventions

This intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins.

experimental group

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Age 5 to 11
  • highly functioning autistic children
  • Either gender will be included
  • children reported with sensory processing difficulties ,language and behaviour issues.

You may not qualify if:

  • Any other neurological condition
  • Children with physical disabilities
  • sedative and hypnotic drug user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saeeda Maryum

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

  • Patterson SY, Smith V, Jelen M. Behavioural intervention practices for stereotypic and repetitive behaviour in individuals with autism spectrum disorder: a systematic review. Dev Med Child Neurol. 2010 Apr;52(4):318-27. doi: 10.1111/j.1469-8749.2009.03597.x.

    PMID: 20412248BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Saeeda Maryum, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
participants will get separate treatment protocols and possible efforts will be put to mask the both groups about the treatment
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5\_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT) . Outcome to be measure and analyze will be repetitive behavior, communication, social interaction and motor skills. Tools used for data collection are REPETITIVE BEHAVIOUR QUESTIONNAIRE (RBQ-2). Gallium autism rating scale (GARS) second edition. Data will be analyzed through the SPSS version 23:00.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

February 24, 2026

Study Start

October 22, 2025

Primary Completion

February 20, 2026

Study Completion

February 23, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations