ParentingNCT03126292
Child Development and Primary Care in Low Income Families
A study testing Sit Down and Play and Child Safety Handout in people with Parenting and Development, Child, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The objective of this study is to conduct a 12-month pilot longitudinal study of a parent-directed program delivered in a primary care setting serving primarily low-income families. Read more about this study
- Who is it for?
- Ages 2 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Parenting, Development, Child
- What is being tested?
- Sit Down and Play and Child Safety Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 19 Dec 2022
- 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 2 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent is 18 years or older
- Child is present for a 2 month well-child visit
- Adult present with child at appointment is parent/caregiver of child
Who cannot join
- Parent is non-English speaking
- Child is acutely sick
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Promoting Early Child Development in Primary Care for Low-Income Families
The objective of this study is to conduct a 12-month pilot longitudinal study of a parent-directed program delivered in a primary care setting serving primarily low-income families. The parent-direction program will be evaluated in a randomized controlled design to determine the feasibility of protocol implementation and to investigate the potential impact on parental outcomes. Process outcomes will include success with recruitment, participant retention, and ability to collect outcome measures. Clinical outcomes will incorporate measures of parental self-efficacy and parenting behaviors, including observational assessments of parent-child interactions.
Read the detailed description
Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and subsequent school readiness skills among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty. However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive program to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.
- Conditions
- Parenting, Development, Child
- Being tested
- Sit Down and Play, Child Safety Handout
- Keywords
- Medical home, Primary care, Children, Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Down and PlayBehavioural
Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room.
Child Safety HandoutOther
Handout regarding early child safety
| Study group | Role | What they receive |
|---|---|---|
| Sit Down and Play | Experimental | Families randomized to intervention group will receive Sit Down and Play while they wait in the waiting room to be seen by their primary care provider at current and subsequent well-child visits. Receives: Behavioral: Sit Down and Play |
| Handout | Active comparator | Families in the control group will receive handouts regarding child safety Receives: Other: Child Safety Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental knowledge regarding importance of verbal interactions
Change in knowledge regarding importance of talking with children less then 2 years of age as measured by the Thirty Million Word Questionnaire
Measured: 6 and 12 months post-enrollment
Participation in cognitively stimulating activities
Participation in cognitively stimulating activities such as reading and play as measured by the StimQ
Measured: 12 months post enrollment
Parent-child interactions
Observational assessment to assess parental sensitivity, involvement in child activities, and engagement in language experiences utilizing the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start20 Oct 2017
- Primary completion5 Jul 2019
- Study completion19 Dec 2022
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 ParentingStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 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, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126292
- Sponsor's protocol ID
- 2014-0337_3
- Other IDs
- K23HD086295
- Status last verified
- Jan 2025
- First submitted
- 18 Apr 2017
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah R, Kennedy S, Clark MD, Bauer SC, Schwartz A. Primary Care-Based Interventions to Promote Positive Parenting Behaviors: A Meta-analysis. Pediatrics. 2016 May;137(5):e20153393. doi: 10.1542/peds.2015-3393. Epub 2016 Apr 19.
PubMed 27244800Shah RP, Kunnavakkam R, Msall ME. Pediatricians' knowledge, attitudes, and practice patterns regarding special education and individualized education programs. Acad Pediatr. 2013 Sep-Oct;13(5):430-5. doi: 10.1016/j.acap.2013.03.003. Epub 2013 Mar 14.
PubMed 23707687
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Early Child Development in Primary Care for Low-Income Families
- ClinicalTrials.gov ID
- NCT03126292
- Acronym / sponsor ID
- 2014-0337_3
- Conditions
- Parenting, Development, Child
- Keywords
- Medical home, Primary care, Children, Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 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
- 20 Oct 2017 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 24 Apr 2017 (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 objective of this study is to conduct a 12-month pilot longitudinal study of a parent-directed program delivered in a primary care setting serving primarily low-income families. The parent-direction program will be evaluated in a randomized controlled design to determine the feasibility of protocol implementation and to investigate the potential impact on parental outcomes. Process outcomes will include success with recruitment, participant retention, and ability to collect outcome measures. Clinical outcomes will incorporate measures of parental self-efficacy and parenting behaviors, including observational assessments of parent-child interactions.
Detailed description
Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and subsequent school readiness skills among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty. However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive program to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sit Down and Play | Experimental | Behavioral: Sit Down and PlayFamilies randomized to intervention group will receive Sit Down and Play while they wait in the waiting room to be seen by their primary care provider at current and subsequent well-child visits. |
| Handout | Active comparator | Other: Child Safety HandoutFamilies in the control group will receive handouts regarding child safety |
Who may qualify
- Ages
- 2 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent is 18 years or older
- Child is present for a 2 month well-child visit
- Adult present with child at appointment is parent/caregiver of child
Key exclusion criteria (2 listed)
- Parent is non-English speaking
- Child is acutely sick
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 PlaySit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room. | Behavioural | Sit Down and Play |
| Child Safety HandoutHandout regarding early child safety | Other | Handout |
Primary outcome
Change in parental knowledge regarding importance of verbal interactions
Time frame: 6 and 12 months post-enrollment
Change in knowledge regarding importance of talking with children less then 2 years of age as measured by the Thirty Million Word Questionnaire
Participation in cognitively stimulating activities
Time frame: 12 months post enrollment
Participation in cognitively stimulating activities such as reading and play as measured by the StimQ
Parent-child interactions
Time frame: 12 months post enrollment
Observational assessment to assess parental sensitivity, involvement in child activities, and engagement in language experiences utilizing the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
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 25 Mar 2026.
- Background: PubMed 27244800Shah R, Kennedy S, Clark MD, Bauer SC, Schwartz A. Primary Care-Based Interventions to Promote Positive Parenting Behaviors: A Meta-analysis. Pediatrics. 2016 May;137(5):e20153393. doi: 10.1542/peds.2015-3393. Epub 2016 Apr 19.
- Background: PubMed 23707687Shah RP, Kunnavakkam R, Msall ME. Pediatricians' knowledge, attitudes, and practice patterns regarding special education and individualized education programs. Acad Pediatr. 2013 Sep-Oct;13(5):430-5. doi: 10.1016/j.acap.2013.03.003. Epub 2013 Mar 14.
- 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, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit Down and Play and Child Safety Handout in people with Parenting and Development, Child, run by University of Illinois Chicago at 1 site in United States.
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 3 inclusion and 2 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 25 Mar 2026. 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 United States. 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?
Change in parental knowledge regarding importance of verbal interactions (time frame: 6 and 12 months post-enrollment). The study lists 3 primary outcomes in all. 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 NCT03126292, 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 25 Mar 2026.