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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Child Safety Handout and Sit Down and Play for Parenting and Child Development?

Research shows that the Sit Down and Play program, when used in primary care settings, significantly improves parenting practices related to child development, especially in low-income families. Parents reported increased positive interactions with their children, which are important for cognitive development. ^{1 2 3 4 5}

Is the Child Safety Handout and Sit Down and Play program safe for children?

The available research suggests that safety education programs, like the Child Safety Handout and Sit Down and Play, are generally safe and can improve parental knowledge and safety practices without reported adverse effects. ^{6 7 8 9 10}

How does the Sit Down and Play treatment differ from other treatments for child development?

The Sit Down and Play treatment is unique because it integrates early childhood development activities into routine healthcare visits, focusing on parent-child interactions through play, which is not commonly emphasized in other child development programs. ^{1 5 7 11 12}

What is the purpose of this trial?

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.

Research Team

Reshma Shah, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. India pubmed.ncbi.nlm.nih.gov

Impact of a Brief Healthcare-based Intervention to Support Early Childhood Development in India: A Pilot Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sit Down and Play: A Preventive Primary Care-Based Program To Enhance Parenting Practices. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Encouraging Parenting Behaviors That Promote Early Childhood Development Among Caregivers From Low-Income Urban Communities: A Randomized Static Group Comparison Trial of a Primary Care-Based Parenting Program. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants With Neuromotor Disorders: A Multisite Randomized Clinical Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Decreasing dangerous infant behaviors through parent instruction. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Education on Preventing Early Childhood Injuries Using a Video Game: The VirtualSafeHome Platform. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety education in a pediatric primary care setting. [2007]

8. United States 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. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Use of a serious game simulation to build early childhood staff capacity for reducing unintentional childhood injuries. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety Detective Program: A Classroom-Based Intervention to Increase Kindergarten Children's Understanding of Home Safety Hazards and Injury-Risk Behaviors to Avoid. [2018]

12. England pubmed.ncbi.nlm.nih.gov

What features of images affect parents' appraisal of safety messages? Examining images from the A Million Messages programme in Canada. [2014]