ParentingNCT02871973
Primary Care-based Program to Enhance Positive Parenting Practices
A study testing Sit Down and Play and Handout in people with Parenting and Development, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
The objective of this research is to conduct a small randomized pilot study to evaluate the feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary care setting to enhance parent-child interactions and explore potential impacts on parenting behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenting, Development, Language
- What is being tested?
- Sit Down and Play and Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent is 18 years or older
- Child is present for a 2, 4, or 6 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: Sit Down and Play: A Primary Care-Based Program to Promote Positive Parenting Practices
The objective of this research is to conduct a small randomized pilot study to evaluate the feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary care setting to enhance parent-child interactions and explore potential impacts on parenting behaviors.
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 school readiness 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 intervention 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, Language, Children
- Being tested
- Sit Down and Play, Handout
- Keywords
- parenting, child development, language
- Medical subject headings
- Language
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.
HandoutBehavioural
Handouts developed by Center for Disease Control and Prevention (CDC) to provide information regarding age-specific early childhood milestones
| Study group | Role | What they receive |
|---|---|---|
| SDP | 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 visit. Receives: Behavioral: Sit Down and Play |
| CDC Handout | Active comparator | Families in the control group will receive the Center for Disease Control and Prevention (CDC) Handout at enrollment. Receives: Behavioral: Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver's participation in cognitively stimulating activities such as reading and playing using self-report measure StimQ
Measured: 3-4 months post-enrollment
Parental Self-Efficacy as measured by Parenting Sense of Competence Scale
Measured: 3-4 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 posted18 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018
- Study completionSep 2018
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reshma Shah, MD, University of Illinois at Chicago
- Investigators
- Reshma Shah, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871973
- Sponsor's protocol ID
- 2014-0337_1
- Other IDs
- UL1TR000050
- Status last verified
- Feb 2020
- First submitted
- 10 Aug 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 R, Sobotka SA, Chen YF, Msall ME. Positive Parenting Practices, Health Disparities, and Developmental Progress. Pediatrics. 2015 Aug;136(2):318-26. doi: 10.1542/peds.2014-3390.
PubMed 26216325
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sit Down and Play: A Primary Care-Based Program to Promote Positive Parenting Practices
- ClinicalTrials.gov ID
- NCT02871973
- Acronym / sponsor ID
- 2014-0337_1
- Conditions
- Parenting, Development, Language, Children
- Keywords
- parenting, child development, language
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 18 Aug 2016 (estimated)
- 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 research is to conduct a small randomized pilot study to evaluate the feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary care setting to enhance parent-child interactions and explore potential impacts on parenting behaviors.
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 school readiness 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 intervention 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDP | 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 visit. |
| CDC Handout | Active comparator | Behavioral: HandoutFamilies in the control group will receive the Center for Disease Control and Prevention (CDC) Handout at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent is 18 years or older
- Child is present for a 2, 4, or 6 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 | SDP |
| HandoutHandouts developed by Center for Disease Control and Prevention (CDC) to provide information regarding age-specific early childhood milestones | Behavioural | CDC Handout |
Primary outcome
Caregiver's participation in cognitively stimulating activities such as reading and playing using self-report measure StimQ
Time frame: 3-4 months post-enrollment
Parental Self-Efficacy as measured by Parenting Sense of Competence Scale
Time frame: 3-4 months post-enrollment
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 13 Feb 2020.
- 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 26216325Shah R, Sobotka SA, Chen YF, Msall ME. Positive Parenting Practices, Health Disparities, and Developmental Progress. Pediatrics. 2015 Aug;136(2):318-26. doi: 10.1542/peds.2014-3390.
- Individual participant dataSharing planned: Undecided
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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 at 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 Handout in people with Parenting and Development, run by University of Illinois at 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 13 Feb 2020. 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?
Caregiver's participation in cognitively stimulating activities such as reading and playing using self-report measure StimQ (time frame: 3-4 months post-enrollment). The study lists 2 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 NCT02871973, 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 13 Feb 2020.