NCT06893666

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

March 19, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Play TherapyDown SyndromeAttentionRandomized Control TrialChild Development

Outcome Measures

Primary Outcomes (1)

  • NHS Attention and Listening Screener

    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

Study Arms (2)

Play based therapy

EXPERIMENTAL

Experimental group was given pay based therapy. Total of 4 sessions were given each session of 40min.

Other: Play based therapy

Child centered play therapy

ACTIVE COMPARATOR

Control group was given child centered play therapy. Total of 4 sessions were given each session of 40min.

Other: Child centered play therapy

Interventions

Experimental group was given pay based therapy. Total of 4 sessions were given each session of 40min.

Play based therapy

Control group was given child centered play therapy. Total of 4 sessions were given each session of 40min.

Child centered play therapy

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with severe sensory impairments
  • Co-morbid neurological conditions that may confound the results
  • Children who received intervention from any other institute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleena Irum

Lahore, Punjab Province, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 30376388BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Aleena Irum, Ms-SLP

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 25, 2025

Study Start

March 28, 2025

Primary Completion

June 30, 2025

Study Completion

July 9, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations