Home Supervision for Preventing Injuries

Overseen By Amy Damashek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western Michigan University

Disqualifiers: Pervasive developmental disorder, Blind, Deaf

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the SHS (Supervision Intervention or Home Supervision Program) can help caregivers better supervise their children at home and reduce injuries for children aged 3-4. The study will divide participants into two groups: one will receive regular home services, while the other will receive additional training on home safety. The trial seeks primary caregivers of a child aged 3-4 who can speak and read English and have not participated in earlier related studies. As an unphased trial, this study offers caregivers the opportunity to contribute to important research that could enhance child safety at home.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this supervision intervention is safe for children?

Research shows that the Supervising for Home Safety (SHS) program receives positive feedback from caregivers. Studies have found that this program reduces the risk of injuries in children by enhancing caregiver supervision. Participants have reported no major negative effects. The SHS program aims to change beliefs and behaviors related to child supervision, offering a supportive and educational experience rather than a medical treatment. This makes it a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on a new approach to preventing injuries in young children by training caregivers in home safety supervision. Unlike traditional methods that might rely on passive safety measures like childproof locks or gates, this approach emphasizes active supervision and engagement from caregivers. By equipping caregivers with the skills to provide adequate supervision, the trial aims to directly reduce the risk of injuries in 3-4-year-old children. This proactive strategy could lead to a more effective and personalized way of keeping kids safe at home.

What evidence suggests that the Supervision Intervention is effective for preventing injuries in children?

Research has shown that the Supervising for Home Safety (SHS) program, which participants in this trial may receive, helps reduce childhood injuries by teaching caregivers how to better watch over children. One study found that caregivers who participated in SHS reported improved supervision, leading to fewer injuries among children. Another study showed a significant drop in injury rates for the group using the SHS program compared to those who did not. These findings suggest that the SHS program can help keep children safer by teaching caregivers more effective supervision methods. ^{1 2 4 5 6}

Who Is on the Research Team?

Amy Damashek

Principal Investigator

Western Michigan University

Are You a Good Fit for This Trial?

This trial is for primary caregivers, regardless of gender, who have a child aged 3-4 years. They must be able to speak and read English and should not have participated in the related focus group study. It excludes families with children diagnosed with pervasive developmental disorders or those who are blind or deaf.

Inclusion Criteria

Caregivers will be eligible to participate if they are the primary caregiver (male or female) for at least one child in the target age range (3-4 years-of-age), the caregiver can speak and read English, and the caregiver did not participate in the focus group study.

Exclusion Criteria

Families in which the target child has been diagnosed with a pervasive developmental disorder

Families in which the target child is blind or deaf.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessments include self-report measures of caregiver supervision beliefs and practices, injury beliefs, and children's injury history, along with an observation of in-home supervision.

1 week

1 visit (in-person)

Treatment

Participants in the treatment group receive the SHS intervention in addition to Head Start home visiting services for 5 weeks.

5 weeks

5 visits (in-person)

Post-test Assessment

Post-test assessments include the same measures as baseline, plus questionnaires on satisfaction and cultural acceptability.

1 week

1 visit (in-person)

Follow-up

A 1-month follow-up to assess sustainability of effects, including supervision and injury measures.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SHS

Trial Overview The study tests a supervision intervention aimed at reducing injury frequency in children. Caregivers will either receive standard services (control) or standard services plus the tailored home supervision program (treatment). The effectiveness will be measured to plan for a larger-scale test.

How Is the Trial Designed?

Group I: Supervising for Home Safety modified Experimental Treatment 1 Intervention

We will train caregivers to provide adequate levels of supervision to the 3-4 year-old children.

Group II: Services as Usual Placebo Group 1 Intervention

Clients will receive home visiting services from Head Start

SHS is already approved in United States for the following indications:

Approved in United States as SHS for:

• Injury prevention in children ages 3-4 years

Who Is Running the Clinical Trial?

Western Michigan University

Lead Sponsor

Trials

18

Recruited

2,900+

University of Guelph

Collaborator

Trials

87

Recruited

15,100+

Published Research Related to This Trial

The Home Safety Supervisory Program (HSSP) significantly reduced the frequency of childhood injuries in the intervention group compared to the control group, indicating its effectiveness in improving child safety.

Caregivers in the intervention group showed improved self-reported home hazard practices and supervisory attitudes, highlighting the program's role in enhancing awareness and safety measures at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Home Safety Supervisory Program on Occurrence of Childhood Injuries: A Cluster Randomized Controlled Trial. George, A., Renu, G., Shetty, S.[2023]

The London Health Sciences Centre Home Safety Program (HSP) effectively reduced emergency department visits for home injuries in children under 2 years old, as shown by a significant decline in visits after the program's implementation.

Parents reported high satisfaction with the HSP, with 94% finding it useful and 81% learning new injury prevention strategies, indicating that education and hazard identification are crucial for enhancing home safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home safe home: Evaluation of a childhood home safety program. Stewart, TC., Clark, A., Gilliland, J., et al.[2018]

In a study of 49 low-income families with children under 5, there was a high agreement (99% for cabinet latches and 100% for stair gates) between parents' self-reports and actual observations of home safety practices.

However, for the safe storage of cleaning supplies, sharps, and medicines, the agreement was lower (62% to 83%), indicating that parents may overreport their safety practices, suggesting the need for direct assessments to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home safety practices in an urban low-income population: level of agreement between parental self-report and observed behaviors. Lee, LK., Walia, T., Forbes, PW., et al.[2018]

The Supervising for Home Safety (SHS) program was successfully adapted for low-income U.S. families, maintaining its core messages about preventing unintentional injuries in young children.

Focus group feedback led to modifications that included diverse family representations and relevant U.S. injury statistics, which helped caregivers relate to the material and increased their awareness of children's injury risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring a Child Injury Prevention Program for Low-Income U.S. Families. Damashek, A., Morrongiello, B., Diaz, F., et al.[2023]

The Supervising for Home Safety program effectively increased parents' awareness of their young children's injury risks and the importance of active supervision, with significant improvements noted immediately after the intervention and lasting for 12 months.

Parents who participated in the program reported higher self-efficacy in supervising their children, suggesting that the program could lead to better supervision practices and potentially reduce child injury risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating the impact of the Supervising for Home Safety program on parent appraisals of injury risk and need to actively supervise. Morrongiello, BA., Sandomierski, M., Zdzieborski, D., et al.[2018]

The Supervising for Home Safety (SHS) program, when delivered in groups to caregivers of 2-5-year-olds, significantly improved caregivers' beliefs about children's vulnerability to injury and their confidence in preventing such injuries.

Caregivers reported high satisfaction and engagement with the program, with 95% completing at least seven out of nine sessions, indicating that the SHS program is both feasible and well-accepted in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervising for Home Safety Program: A Randomized Controlled Trial (RCT) Testing Community-Based Group Delivery. Morrongiello, BA., Hou, S., Bell, M., et al.[2018]

A study involving 87 public health nurses and social workers found that only 41% of home visitors discussed injury prevention with parents during visits, highlighting a gap in addressing childhood injury risks.

Despite some home visitors assessing home environments for hazards, many did not use structured safety checklists, indicating a need for improved training and systematic approaches to enhance injury prevention practices in home visiting programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home visitors' beliefs and practices regarding childhood injury prevention. Pratt, LK., Runyan, CW., Cohen, LR., et al.[2019]

The study involved 100 families in France and found that those who received a safety kit along with counseling showed a significantly higher percentage of safety improvements in preventing child injuries compared to those who only received counseling.

Families with the safety kit demonstrated a 67.8% improvement in safety measures related to the devices provided, while those without the kit only showed a 38.1% improvement, highlighting the effectiveness of the kit in promoting safer home environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of an injury prevention kit delivery for toddlers in four French cities]. Sznajder, M., Janvrin, MP., Albonico, V., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10147337/

Tailoring a Child Injury Prevention Program for Low- ... Supervising for Home Safety (SHS) is a Canadian intervention that has been shown to reduce children's injury risk by increasing caregiver supervision. Given ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27771617/

Supervising for Home Safety Program: A Randomized ... Objective: The individually delivered Supervising for Home Safety (SHS) program improves caregivers' injury-related beliefs and supervision ...

3. withpower.com withpower.com/trial/phase-wounds-and-injuries-9-2020-3a5f0

Home Supervision for Preventing Injuries Research shows that the Supervising for Home Safety (SHS) program helps caregivers improve their supervision practices and beliefs about injury prevention, ...

4. link.springer.com link.springer.com/article/10.1007/s13312-021-2238-y

Effect of a Home Safety Supervisory Program on ... The intervention group had a significant reduction in the frequency of childhood injuries when compared with the control group [MD (95% CI) 8.96 ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1037/cpp0000421

Tailoring a Child Injury Prevention Program for Low ... This study describes a process of modifying the SHS program to be culturally appropriate for low-income families of US preschool children.

6. injuryprevention.bmj.com injuryprevention.bmj.com/content/23/Suppl_1/A36.1

96 'supervising for home safety' program: a randomised ... Results In the SHS ... Significance and Contribution The SHS program is the only program proven to improve caregivers' supervision of young children in the home.