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

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.

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

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

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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