NCT03517475

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
5.3 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

6 days

First QC Date

February 26, 2018

Last Update Submit

September 16, 2025

Conditions

Injuries

Outcome Measures

Primary Outcomes (1)

  • Supervision levels

    11 weeks

Secondary Outcomes (1)

  • Injury Frequency

    11 weeks

Study Arms (2)

Supervising for Home Safety modified

EXPERIMENTAL

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

Behavioral: SHS Low-Income

Services as Usual

PLACEBO COMPARATOR

Clients will receive home visiting services from Head Start

Behavioral: SHS Low-Income

Interventions

SHS Low-IncomeBEHAVIORAL

An intervention to train caregivers to supervise their children appropriately.

Services as UsualSupervising for Home Safety modified

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • We will exclude families in which the target child has been diagnosed with a pervasive developmental disorder or is blind or deaf.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Michigan University

Kalamazoo, Michigan, 49008, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Amy Damashek

    Western Michigan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

May 7, 2018

Study Start

September 1, 2023

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

US(1)