Development, ChildPhase 1NCT04167254
Sit Down and Play India
A Phase 1 study testing Sit Down and Play in people with Development, Child, run by University of Illinois Chicago at 2 sites in 2 countries.
Trial summary
To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Development, Child
- What is being tested?
- Sit Down and Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Feb 2020to 1 Apr 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents/legal guardians will be eligible if they:
- Are over the age of 18 years
- Have a child between 6 and 10 weeks
- Are presenting to Deshnur and Murgod Primary Health Centers in Karnataka, India for a heatlh visit and
- Self-identify as the "primary caregiver.
Who cannot join
- Parents/legal guardians will be ineligible if they:
- Are less than the age of 18 years
- Have a child who is not between 6 and 10 weeks or
- Have a child who is sick at the time of visit
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Feasibility of Implementing Sit Down and Play in Routine Visits in India
To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development.
- Conditions
- Development, Child
- Being tested
- Sit Down and Play
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Down and PlayBehavioural
Brief health care-based program that aims to promote key parenting behaviors that promote early childhood development
| Study group | Role | What they receive |
|---|---|---|
| Sit Down and Play | Experimental | Not described Receives: Behavioral: Sit Down and Play |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Behaviors that Promote Early Childhood developme
Key items from the UNICEF Multiple Indicator Cluster Surveys Early Childhood Development Module
Measured: 1 month after second immunization visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start7 Feb 2020
- Primary completion18 Aug 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Development, ChildStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Reshma Shah, MD, University of Illinois Chicago
- Investigators
- Reshma Shah, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167254
- Sponsor's protocol ID
- 2014-0337_4
- Status last verified
- Apr 2021
- First submitted
- 14 Nov 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah R, Herekar V, Metgud D, Kim H, Atkins M, Dhaded S. Implementing an early childhood development intervention with routine immunization visits in India: a feasibility trial. Eur J Pediatr. 2022 Jul;181(7):2799-2808. doi: 10.1007/s00431-022-04485-w. Epub 2022 May 5.
PubMed 35508559
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing Sit Down and Play in Routine Visits in India
- ClinicalTrials.gov ID
- NCT04167254
- Acronym / sponsor ID
- 2014-0337_4
- Conditions
- Development, Child
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 18 Nov 2019 (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.
To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sit Down and Play | Experimental | Behavioral: Sit Down and Play |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are over the age of 18 years
- Have a child between 6 and 10 weeks
- Are presenting to Deshnur and Murgod Primary Health Centers in Karnataka, India for a heatlh visit and
- Self-identify as the "primary caregiver.
Key exclusion criteria (4 listed)
- Are less than the age of 18 years
- Have a child who is not between 6 and 10 weeks or
- Have a child who is sick at the time of visit
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 |
|---|---|---|
| Sit Down and PlayBrief health care-based program that aims to promote key parenting behaviors that promote early childhood development | Behavioural | Sit Down and Play |
Primary outcome
Parenting Behaviors that Promote Early Childhood developme
Time frame: 1 month after second immunization visit
Key items from the UNICEF Multiple Indicator Cluster Surveys Early Childhood Development Module
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 3 May 2021.
- Derived from this study: PubMed 35508559Shah R, Herekar V, Metgud D, Kim H, Atkins M, Dhaded S. Implementing an early childhood development intervention with routine immunization visits in India: a feasibility trial. Eur J Pediatr. 2022 Jul;181(7):2799-2808. doi: 10.1007/s00431-022-04485-w. Epub 2022 May 5.
- 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.
Reshma Shah principal investigator
University of Illinois Chicago
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sit Down and Play in people with Development, Child, run by University of Illinois Chicago at 2 sites in 2 countries.
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 5 inclusion and 4 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parenting Behaviors that Promote Early Childhood developme (time frame: 1 month after second immunization visit). 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 NCT04167254, which also lists 1 linked publication.
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 3 May 2021.