Down SyndromeNCT06893666
Effects of Play Based Therapy on Attention Level of Children With Down Syndrome
A study testing Play based therapy and Child centered play therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Play based therapy and Child centered play therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Mar 2025to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with severe sensory impairments
- Co-morbid neurological conditions that may confound the results
- Children who received intervention from any other institute
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Down Syndrome
- Being tested
- Play based therapy, Child centered play therapy
- Keywords
- Play Therapy, Down Syndrome, Attention, Randomized Control Trial, Child Development
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play based therapyOther
Experimental group was given pay based therapy. Total of 4 sessions were given each session of 40min.
Child centered play therapyOther
Control group was given child centered play therapy. Total of 4 sessions were given each session of 40min.
| Study group | Role | What they receive |
|---|---|---|
| Play based therapy | Experimental | Experimental group was given pay based therapy. Total of 4 sessions were given each session of 40min. Receives: 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. Receives: Other: Child centered play therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start28 Mar 2025
- Primary completion30 Jun 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleena Irum, Ms-SLP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893666
- Sponsor's protocol ID
- REC/RCR&AHS/24/0678
- Status last verified
- Jul 2025
- First submitted
- 19 Mar 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30376388Manshi, 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 at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Play Based Therapy on Attention Level of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06893666
- Acronym / sponsor ID
- REC/RCR&AHS/24/0678
- Conditions
- Down Syndrome
- Keywords
- Play Therapy, Down Syndrome, Attention, Randomized Control Trial, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Play based therapy | Experimental | Other: Play based therapyExperimental group was given pay based therapy. Total of 4 sessions were given each session of 40min. |
| Child centered play therapy | Active comparator | Other: Child centered play therapyControl group was given child centered play therapy. Total of 4 sessions were given each session of 40min. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with severe sensory impairments
- Co-morbid neurological conditions that may confound the results
- Children who received intervention from any other institute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Play based therapyExperimental group was given pay based therapy. Total of 4 sessions were given each session of 40min. | Other | Play based therapy |
| Child centered play therapyControl group was given child centered play therapy. Total of 4 sessions were given each session of 40min. | Other | Child centered play therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 30376388Lu 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.
- BackgroundManshi, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleena Irum, Ms-SLP principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play based therapy and Child centered play therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NHS Attention and Listening Screener (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.