- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893666
Effects of Play Based Therapy on Attention Level of Children With Down Syndrome
July 14, 2025 updated by: Riphah International University
The aim of the study is to examine the attention level of children with down syndrome receiving play based therapy as compared to children receiving child centered play therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Aleena Irum
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age: 3-5 years
- Gender: Both male and female
- Children who are currently taking speech therapy sessions with parental involvement.
- Medically stable children with no severe ongoing health issues that could interfere with their participation in the study.
Exclusion Criteria:
- Children with severe sensory impairments
- Co-morbid neurological conditions that may confound the results
- Children who received intervention from any other institute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Play based therapy
Experimental group was given pay based therapy.
Total of 4 sessions were given each session of 40min.
|
Experimental group was given pay based therapy.
Total of 4 sessions were given each session of 40min.
|
|
Active Comparator: Child centered play therapy
Control group was given child centered play therapy.
Total of 4 sessions were given each session of 40min.
|
Control group was given child centered play therapy.
Total of 4 sessions were given each session of 40min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NHS Attention and Listening Screener
Time Frame: Baseline and 4 weeks
|
The screener was designed to measure attention and listening of children.
It is dichotomous (yes/no) comprising of 9 items according to age rang of 3-5 years.
|
Baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aleena Irum, Ms-SLP, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lu WP, Tsai WH, Lin LY, Hong RB, Hwang YS. The Beneficial Effects of Massage on Motor Development and Sensory Processing in Young Children with Developmental Delay: A Randomized Control Trial Study. Dev Neurorehabil. 2019 Oct;22(7):487-495. doi: 10.1080/17518423.2018.1537317. Epub 2018 Oct 30.
- Manshi, Dimple Choudhry, Anshu Kumari, & Priyanka Gulati. (2023). To Compare the Attention Span of Down Syndrome Children with Healthy Children of Same Age Group. International Journal of Medical Science and Diagnosis Research, 7(2). https://doi.org/10.32553/ijmsdr.v7i2.976
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2025
Primary Completion (Actual)
June 30, 2025
Study Completion (Actual)
July 9, 2025
Study Registration Dates
First Submitted
March 19, 2025
First Submitted That Met QC Criteria
March 19, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
July 15, 2025
Last Update Submitted That Met QC Criteria
July 14, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0678
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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