Home Supervision Intervention for Healthy Subjects

Overseen By Amy Damashek, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western Michigan University

Disqualifiers: Pervasive developmental disorder, blind, deaf

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

Compensation: Varies

Number of Visits: 6

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Latinx families in Southwest Michigan improve supervision of young children to reduce injuries. The study tests a modified SHS (Supervision Home Safety) intervention program to determine its effectiveness in teaching caregivers how to better monitor their children and prevent minor injuries. Participants will either join a group focused on child supervision or receive general advice on managing common child behavior issues. The trial seeks Spanish-speaking caregivers of children aged 15 months to 5 years old who do not have certain developmental issues.

As an unphased trial, this study offers a unique opportunity to contribute to important research that could benefit the community.

Do I need to stop my current medications for this trial?

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

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

Research has shown that the Supervising for Home Safety (SHS) program is well-received. It reduces the risk of childhood injuries by teaching caregivers better supervision techniques. Studies indicate that the SHS program enhances caregiver vigilance, resulting in fewer home injuries.

One study found that families using the SHS program experienced a noticeable decrease in childhood injuries compared to those not using it. No major reports of negative effects from the program have emerged. It primarily involves educational sessions for caregivers, which are generally safe.

Overall, SHS appears to be a safe and effective method for helping caregivers protect their children from home injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance caregiver supervision and reduce children's risk of injury. Unlike standard methods that typically provide general safety guidelines or corrective behavior strategies, this intervention involves a group-based approach that actively teaches caregivers how to closely supervise their children. The unique focus on enhancing real-time supervision and interaction is what sets this study apart, aiming to offer practical strategies for preventing injuries rather than just managing behaviors after they occur.

What evidence suggests that this intervention is effective for increasing caregiver supervision and reducing children's injury risk?

The current trial will evaluate the effectiveness of the Supervising for Home Safety (SHS) program. Studies have shown that this program can reduce the risk of child injuries by improving caregiver supervision. Research indicates that the SHS program enhances caregivers' beliefs and actions related to injury prevention. One study found that the program helps parents better identify and manage potential safety risks. These findings suggest that the SHS program holds promise for improving child safety through better supervision. ^{1 2 3 4 6}

Who Is on the Research Team?

Amy Damashek, Ph.D.

Principal Investigator

Western Michigan University

Are You a Good Fit for This Trial?

This trial is for Latinx caregivers with children ages 2-5 in Southwest Michigan. Participants will be involved in focus groups and a randomized controlled trial (RCT) to tailor a home supervision intervention. Caregivers must be connected to local Latinx resource centers or a Head Start program.

Inclusion Criteria

I am a Spanish-speaking caregiver of a child aged 15 months to 5 years.

Exclusion Criteria

Child of caregiver has pervasive developmental disorder

Child of caregiver is blind

My child is deaf.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Modification

Focus groups are conducted to modify intervention materials for cultural relevance

4-6 weeks

Multiple focus group sessions

Pilot Test

Pilot test the modified intervention with a small group of families

2 weeks

1 group session

RCT

Randomized controlled trial to test the effects of the modified intervention

7 weeks

4 in-person sessions for treatment group, 3 for control group

Follow-up

Participants are monitored for sustainability of effects post-intervention

4 weeks

1 in-person session

What Are the Treatments Tested in This Trial?

Interventions

• SHS

Trial Overview The study tests the SHS intervention, adapted for Latinx families, through an iterative process involving feedback from participants. The effectiveness of the modified materials on improving child supervision and reducing minor injuries will be evaluated.

How Is the Trial Designed?

Group I: intervention to increase caregiver supervision and reduce child's risk for injury Experimental Treatment 1 Intervention

Group-based intervention to teach caregivers about ways to supervise their children more closely.

Group II: Control group Active Control 1 Intervention

caregivers received information about how to manage common child behavior problems.

Who Is Running the Clinical Trial?

Western Michigan University

Lead Sponsor

Trials

18

Recruited

2,900+

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. academic.oup.com academic.oup.com/jpepsy/article/42/7/768/2439506

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

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03517475

Tailoring a Home Supervision Intervention for Low-Income ... The investigators will pilot test (N=100 caregivers of children ages 3-4 years) the effects of a caregiver supervision intervention on caregivers' ...

4. awspntest.apa.org awspntest.apa.org/doi/10.1037/a0028214

A randomized controlled trial evaluating the impact of the ... Conclusions: The Supervising for Home Safety program produced the desired effects on parental appraisals. It holds promise as a program that may improve parents ...

5. pediatrics.jmir.org pediatrics.jmir.org/2025/1/e67877

Evidence of Interventions for the Prevention of Unintentional ... The results of this review can assist researchers and health care professionals in implementing injury prevention interventions and creating ...

6. 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 ...