NCT05260502

Brief Summary

The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

February 2, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 2, 2022

Last Update Submit

February 18, 2022

Conditions

Keywords

sensory disintegration

Outcome Measures

Primary Outcomes (1)

  • sensory disintegration in neurodevelopmental disorders

    Estimate the prevalence of sensory disintegration problems among study groups and differentiate the pattern of sensory disintegration problems among study groups.

    2 years

Study Arms (3)

Autistic children

magnetic resonance imaging brain for autistic children

attention deficit hyperactivity disorder children

magnetic resonance imaging brain for attention deficit hyperactivity disorder children

Normal children

magnetic resonance imaging brain for Normal children

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Both males and females were included. Age ranges from 6- 18 years.

You may qualify if:

  • Willing of the parents or the caregivers to participate in the study.

You may not qualify if:

  • Children with intelligence quotient below 70. .Children with history or current substance use. .Children with medical or other neurological conditions. .Children with history of preterm labour (as brain volume lower than term delivery).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Gourley L, Wind C, Henninger EM, Chinitz S. Sensory Processing Difficulties, Behavioral Problems, and Parental Stress in a Clinical Population of Young Children. J Child Fam Stud. 2013 Oct 1;22(7):912-921. doi: 10.1007/s10826-012-9650-9.

    PMID: 24443636BACKGROUND
  • Al-Heizan MO, AlAbdulwahab SS, Kachanathu SJ, Natho M. Sensory processing dysfunction among Saudi children with and without autism. J Phys Ther Sci. 2015 May;27(5):1313-6. doi: 10.1589/jpts.27.1313. Epub 2015 May 26.

    PMID: 26157208BACKGROUND
  • Schaaf RC, Lane AE. Toward a Best-Practice Protocol for Assessment of Sensory Features in ASD. J Autism Dev Disord. 2015 May;45(5):1380-95. doi: 10.1007/s10803-014-2299-z.

    PMID: 25374136BACKGROUND

Central Study Contacts

Amira Mohammed Moheb, assistant lecturer

CONTACT

Alaa El-Dien Mohamed Darwish, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 2, 2022

First Posted

March 2, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

March 2, 2022

Record last verified: 2022-02