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InjuriesNCT03517475

Tailoring a Home Supervision Intervention for Low-Income Families

A study testing SHS Low-Income in people with Injuries, run by Western Michigan University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Injuries
What is being tested?
SHS Low-Income
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
89 participants
Where
1 siteUnited States
Study dates
1 Sep 2023to 7 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Western Michigan University

    Kalamazoo, Michigan, 49008

Other trials in United States

About this study

Official title: Prevention of Injuries Among Young Children: Tailoring a Home Supervision Intervention for Low-Income Caregivers

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.

Read the detailed description

For the RCT, the investigators will recruit Head Start participants with help from the home visitors (using procedures that are similar to phase 1 recruitment procedures). The home visitors will read a short script about the study to eligible clients; it will be emphasized that the Head Start services they receive will not be impacted by their decision about whether or not to participate. Interested caregivers will sign a release form for the home visitors to provide the caregiver's contact information to study personnel. A Graduate Research Assistant (GRA) will then call the caregivers and will read a recruitment script. If the caregiver is interested in participating, the GRA will set up a meeting in the caregiver's home to complete consent and baseline measures. 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. The investigators will exclude families in which the target child has been diagnosed with a pervasive developmental disorder or is blind or deaf because such conditions often result in specialized supervision requirements, and the investigators have not tailored the intervention to be appropriate for such families. Later research may examine whether the intervention or a modified version of it, is appropriate for such families. If there is more than one child in the home who is attending Head Start and is between the ages of 3-4 years, the investigators will use a random procedure to choose the target child. Participants who consent will be randomly assigned to either the treatment or control condition by the primary investigator after the consent appointment. A blinded design will be used so the GRA who will collect data will not know who is in the treatment group.

A GRA and URA will administer baseline, post-test, and follow-up assessments at participants' homes. Baseline assessments will include three self-report measures of caregiver supervision beliefs and practices, a measure of caregivers' injury beliefs, and a measure of children's injury history. The investigators will also conduct an observation of in-home supervision and collect data on current injuries. The baseline, post, and follow-up sessions will take approximately one hour. If needed, the GRA will assist caregivers with low literacy to complete the measures by reading the measures aloud or by answering questions about the measures. The investigators have used this approach successfully in previous studies (Damashek \& Corlis, 2017; Damashek, Hughes, Chahin, \& Corlis, 2017). After the baseline session, primary caregivers randomized to the treatment condition will participate in one-hour intervention sessions in their home for 5 weeks. Those randomized to the treatment group will receive the tailored SHS intervention in addition to their Head Start home visiting services (SHS+SAU); those randomized to the control group will only receive the Head Start home visiting services (SAU). A GRA will deliver the intervention to the treatment group and will be assisted by an Undergraduate Research Assistant (URA). The GRA will be trained by the co-investigator to deliver SHS and will use a manual to guide delivery (based on previous work, Morrongiello et al., 2017).

A week after the last intervention session (or an equivalent time period for the control group), the GRA and URA will return to the participant's home and will re-administer the same measures taken at baseline, in addition to questionnaires assessing their satisfaction with the intervention and perception of the intervention's cultural acceptability. The investigators will conduct a 1-month follow-up to assess for sustainability of effects during which the investigators will administer the same supervision and injury measures as at baseline.

In addition to self-report measures, the investigators will conduct pre-, post-, and follow-up observational assessments of maternal supervision, based on an innovative testing protocol developed by Morrongiello and her colleagues (Morrongiello, McArthur, Goodman, \& Bell, 2015). During the data collection appointments, the investigators will set up a situation in which the investigators will observe caregivers' supervision of their child while they are distracted and while their child is exposed to an interesting and potentially hazardous object (a "gadget", see Measures).

The investigators will also collect data on children's minor everyday injury frequencies using a structured injury interview that will be administered weekly via telephone; this measure has been used in previous research by the PI (Damashek \& Corlis, 2017). The first interview will be administered in person during the baseline data collection session. A second baseline injury interview will occur 1 week before caregivers participate in their first intervention session. Additional administrations will occur weekly via telephone through the follow-up data collection appointment.

Conditions
Injuries
Being tested
SHS Low-Income
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHS Low-IncomeBehavioural

    An intervention to train caregivers to supervise their children appropriately.

Study groups in NCT03517475
Study groupRoleWhat they receive
Supervising for Home Safety modifiedExperimentalWe will train caregivers to provide adequate levels of supervision to the 3-4 year-old children.
Receives: Behavioral: SHS Low-Income
Services as UsualPlacebo comparatorClients will receive home visiting services from Head Start
Receives: Behavioral: SHS Low-Income

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Supervision levels

    Measured: 11 weeks

Secondary outcomes (1)
  1. Injury Frequency

    Measured: 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2018
  2. Study start1 Sep 2023
  3. Primary completion7 Sep 2023
  4. Study completion7 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03517475
Sponsor's protocol ID
AD3874920
Status last verified
Sep 2025
First submitted
26 Feb 2018
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing SHS Low-Income in people with Injuries, run by Western Michigan University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Supervision levels (time frame: 11 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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