NCT06373770

Brief Summary

Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 16, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensory profile by winnie dunn

    sensory profile by winnie dunn willl be used to measure primary outcomes or initial assessment

    12 Months

Study Arms (2)

Ayres sensory integration therapy

EXPERIMENTAL

A. Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment.

Diagnostic Test: Ayres sensory integration therapy

Behaviour therapy

OTHER

The current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis.

Diagnostic Test: Behaviour Therapy

Interventions

A. Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment. Sensory information may be visual, auditory, tactile, proprioceptive, and/or vestibular in nature. ASI uses individually tailored activities that utilize "just right" challenges to an individual's existing patterns of sensory processing and motor planning and encourage movement and organization of self in time and space. ASI incorporates specialized equipment and materials in purposeful and playful activities in order to improve adaptive behavior.

Ayres sensory integration therapy
Behaviour TherapyDIAGNOSTIC_TEST

The current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis. Medications have been most effective in treating the associated behavioral symptoms of autism, though studies have examined potential benefits in some of the core symptoms of autism with certain medications, especially the repetitive behaviors often seen with this diagnosis. Risperidone and aripiprazole are currently the only medications FDA approved for symptoms associated with autism spectrum disorders, targeting the irritability often seen with this diagnosis.

Behaviour therapy

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed cases of autism age range from 2 year to 8 years.
  • All patients will be assed using sensory profile by Winnie Dunn.

You may not qualify if:

  • All other patients not having diagnosed as autism spectrum criteria are excluded.
  • All patients with sensory processing disorder assessed by using sensory profile.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RICCER Institute

Faisalabad, Punjab Province, Pakistan

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
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 18, 2024

Study Start

October 1, 2023

Primary Completion

June 1, 2024

Study Completion

September 30, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations