Child Safety Handout and Sit Down and Play for Parenting and Child Development

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Non-English speaking, Acutely sick child

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called "Sit Down and Play" to evaluate its impact on parenting skills and interactions with children. Researchers conduct the study in clinics serving mostly low-income families to determine if the program is user-friendly and beneficial for parents. Participants will either receive child safety handouts or engage in "Sit Down and Play" activities during clinic visits. Parents with a two-month-old child attending a well-child visit can join, provided they speak English and their child is not currently sick. As an unphased trial, this study offers parents a unique opportunity to contribute to research that could enhance parenting programs for similar families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for parenting and child development?

Research has shown that the "Sit Down and Play" program is safe for parents and their children. This program aims to enhance parent-child interactions and support child development. Previous studies found it easy to use and popular in doctor's offices.

These studies reported no safety issues. The program provides parents with fun activities to engage in with their children while waiting for appointments, making it a low-risk option.

Overall, evidence supports that "Sit Down and Play" is a safe choice for families and can improve parent-child interactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Sit Down and Play" intervention because it offers a fresh approach to supporting parenting and child development. Unlike traditional methods, which often rely on handouts or verbal advice, this technique involves interactive play sessions while families wait for their appointments. This hands-on approach not only engages children but also provides parents with direct, practical examples of developmental activities. By integrating this playful intervention into routine healthcare visits, the hope is to create a more engaging and supportive environment for families, potentially leading to better developmental outcomes for children.

What evidence suggests that this trial's treatments could be effective for parenting and child development?

Research has shown that the Sit Down and Play (SDP) program, an intervention in this trial, helps parents improve their parenting skills. Studies have found that SDP enhances parent-child interactions and supports children's growth, including better movement skills in babies. The program is brief and occurs during regular child check-ups, offering convenience for busy parents. It has also successfully improved children's development and health. Overall, evidence suggests that SDP is a valuable tool for boosting parenting skills and child development. Meanwhile, families in the trial's control group will receive handouts on child safety. ^{1 2 6 7 8}

Who Is on the Research Team?

Reshma Shah, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for parents or caregivers aged 18 and older who are attending a primary care setting with their child for a 2-month well-child visit. It's aimed at low-income families to assess the impact of a parent-directed program on parenting skills.

Inclusion Criteria

Child is present for a 2 month well-child visit

Adult present with child at appointment is parent/caregiver of child

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Sit Down and Play program during well-child visits to promote positive parenting behaviors

12 months

Visits coincide with regular well-child visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Child Safety Handout
• Sit Down and Play

Trial Overview The study tests two interventions: 'Child Safety Handout' and 'Sit Down and Play'. Over 12 months, it will use randomized controlled design to see if these can improve parental self-efficacy and behaviors in low-income families.

How Is the Trial Designed?

Group I: Sit Down and Play Experimental Treatment 1 Intervention

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.

Group II: Handout Active Control 1 Intervention

Families in the control group will receive handouts regarding child safety

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Parents who participated in an individualized, three-part safety education program recognized more home hazards (9.4 vs. 8.4) compared to those who received standard education, indicating improved safety knowledge.

The intervention group also had a lower mean hazard score (2.4 vs. 3.0) in their homes, suggesting that the tailored safety education led to better safety practices, although reported accidents were similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety education in a pediatric primary care setting. Kelly, B., Sein, C., McCarthy, PL.[2007]

The VirtualSafeHome (VSH) tool effectively increased awareness of household hazards among adults, with participants identifying a median of 15.5 hazards during gameplay.

Participants showed a significant improvement in safety knowledge, with pretest scores rising from 2.0 to 2.79 after using the VSH, indicating that this engaging, web-based game can be a valuable resource for home safety education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education on Preventing Early Childhood Injuries Using a Video Game: The VirtualSafeHome Platform. Woolf, AD., Jacobson, J., Flanagan, S., et al.[2023]

The Sit Down and Play (SDP) program, implemented in a primary care setting, showed significant improvements in parenting practices related to child development among 30 caregivers of infants aged 6-12 months over a 1-month period.

Caregivers reported high satisfaction with the program, highlighting the importance of play and noticing positive changes in their children, suggesting that SDP is a feasible intervention that could enhance parenting behaviors during pediatric visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sit Down and Play: A Preventive Primary Care-Based Program To Enhance Parenting Practices. Shah, R., DeFrino, D., Kim, Y., et al.[2022]

The Safe Kids Hospital (SKH) app significantly improved safety awareness among hospitalized children aged 3-6 years, with a notable increase in scores from 17.80 to 24.53 after using the app, indicating its effectiveness as an educational tool.

Participants found the SKH app easy to use and enjoyable, highlighting its acceptability and feasibility for teaching safety in pediatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Effects of a Mobile Application for Safety Incident Prevention among Hospitalized Korean Children: A pilot Study of Feasibility and Acceptability. Han, J., Oh, WO., Park, IT., et al.[2021]

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34415470/

Examining Implementation Outcomes of Sit Down and Play, a ... We designed Sit Down and Play (SDP) with the aim of creating a brief primary care-based program that encourages positive parenting practices through take-home ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5714307/

Sit Down and Play: A Preventive Primary Care-Based ... Moreover, our results show that SDP is associated with a self-reported increased frequency of positive parenting practices. These results ...

3. world.physio world.physio/congress-proceeding/impact-sit-down-and-play-intervention-neuromotor-development-and-parent-child

IMPACT OF SIT DOWN AND PLAY INTERVENTION ON ... Sit down and play intervention is an effective intervention for enhancing the parent child behavior and improving the neuromotor development in young infants.

4. link.springer.com link.springer.com/article/10.1007/s12098-025-05498-7

The Sit Down and Play Intervention Improves ... This study explored how SDP impacts neurodevelopmental outcomes in healthy infants attending a well-baby clinic in Belagavi, Karnataka.

5. publications.aap.org publications.aap.org/pediatrics/article/147/3_MeetingAbstract/78/4970/Supporting-Evidence-based-Parenting-Behaviors-in

Supporting Evidence-based Parenting Behaviors in ... We designed Sit Down and Play (SDP) to be a brief, population-level, primary care-based program that aims to optimize developmental and health outcomes for ...

6. withpower.com withpower.com/trial/phase-9-2017-ce3d9

Child Safety Handout and Sit Down and Play for Parenting ... The Sit Down and Play (SDP) program, implemented in a primary care setting, showed significant improvements in parenting practices related to child development ...

7. researchgate.net researchgate.net/publication/364357174_Effects_of_an_Online_Play-Based_Parenting_Program_on_Child_Development_and_the_Quality_of_Caregiver-Child_Interaction_A_Randomized_Controlled_Trial

Effects of an Online Play-Based Parenting Program on ... An intention-to-treat analysis was conducted. Results The intervention showed positive effects on child development, by improving language ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0190740923004656

Improving child behavior through parent training in ... Regression analysis was used to test the hypotheses: (1) Parents in the treatment condition demonstrated better parenting outcomes than parents in the services- ...