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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will pilot test (N=100 caregivers of children ages 3-4 years) the effects of a caregiver supervision intervention on caregivers' supervision and children's injury frequency using a Randomized Controlled Trial (RCT) design. The control group will receive Services as Usual (SAU), and the treatment group will receive SAU+ SHS. The results will be used to support an R01 application to conduct a larger-scale RCT test of the program.

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 data supports the effectiveness of the treatment SHS, Supervision Intervention, Home Supervision Program?

Research shows that the Supervising for Home Safety (SHS) program helps caregivers improve their supervision practices and beliefs about injury prevention, which reduces the risk of injuries in children. The program has been adapted for different communities, including low-income families, and has been shown to increase parents' awareness of injury risks and the importance of active supervision. ^{1 2 3 4 5}

Is the Home Supervision Program safe for humans?

The Home Supervision Program, also known as SHS, has been tested in various studies and is generally considered safe. It focuses on improving caregiver supervision to prevent injuries, particularly in children, and has been adapted for different cultural contexts without reported safety concerns. ^{1 2 3 6 7}

How is the Home Supervision Program (SHS) treatment different from other treatments for preventing injuries?

The Home Supervision Program (SHS) is unique because it focuses on improving caregivers' beliefs and practices regarding supervision to prevent injuries, particularly in young children, by using community-based group delivery and tailored activities. Unlike other treatments that may focus on eliminating hazards, SHS emphasizes changing caregiver behavior and increasing awareness of injury risks. ^{1 2 3 5 8}

Research Team

Amy Damashek

Principal Investigator

Western Michigan University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

References

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

Supervising for Home Safety Program: A Randomized Controlled Trial (RCT) Testing Community-Based Group Delivery. [2018]

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

Tailoring a Child Injury Prevention Program for Low-Income U.S. Families. [2023]

3. United States 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. [2018]

4. India pubmed.ncbi.nlm.nih.gov

Effect of a Home Safety Supervisory Program on Occurrence of Childhood Injuries: A Cluster Randomized Controlled Trial. [2023]

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

Home safe home: Evaluation of a childhood home safety program. [2018]

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

Home safety practices in an urban low-income population: level of agreement between parental self-report and observed behaviors. [2018]

7. France pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of an injury prevention kit delivery for toddlers in four French cities]. [2019]

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

Home visitors' beliefs and practices regarding childhood injury prevention. [2019]