NCT07203612

Brief Summary

The aim of the proposed study is to create and test a modified version of the SHS intervention for Latinx families in Southwest Michigan. We will partner with three nearby Latinx resource centers in addition to a Head Start program that provides preschool to a large number of Latinx families. The project will use an iterative approach to modifying the intervention and will occur in five steps. In step 1, we will conduct focus groups with caregivers and staff from the 3 Latinx resource centers to identify changes to make to the intervention materials. In step 2, we will make modifications to the program materials. In step 3, we will conduct additional focus groups to seek feedback about the revised program materials. In step 4, we will pilot test the revised program materials, and in step 5 we will conduct the RCT of the modified program materials with caregivers of children ages 2-5. We will examine the effect of the modified intervention on caregivers' supervision of their children (using self-reports and observations) and on children's minor injury frequency.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
4mo left

Started May 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress86%
May 2024Aug 2026

Study Start

First participant enrolled

May 9, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

September 16, 2025

Last Update Submit

September 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Supervision Behavior

    Caregivers will complete the Computerized Supervision Observation Measure (CSOM), which is a 20-minute observational measure of supervision that was created by Dr. Morrongiello (Morrongiello et al., 2010). The measure assesses the frequency with which caregivers verbally intervene to address risky child behavior (e.g., climbing on a dresser) as well as the type of verbal comment that they make (e.g., prohibitions, directives, or teaching comments). Each parent will view a videotape of a young child (same sex as their own) in a naturalistic home setting. The video will show a child moving throughout the home playing in different areas (living room, kitchen). Parent responses will be coded to rate the degree to which they respond effectively to children' engagement in risky behavior. Coding categories include: prohibitions or threats (e.g., don't do that"), directions or control statements (e.g., "you can put that over there") and teaching/explanations (e.g., "that's hot).

    baseline, immediate post-intervention, 1 month post-intervention

  • Parent Supervision Attributes Profile Questionnaire (PSAPQ)

    The PSAPQ will be administered at baseline, immediately post-intervention, and at 1 month post-intervention. The PSAPQ is a measure of parents' supervision practices and beliefs (Morrongiello \& Corbett, 2006; Morrongiello \& House, 2004). It is comprised of 29 items organized into 4 subscales (protectiveness, supervision, tolerance for risk taking, and belief that fate determines a child's injury risk). Caregivers use a 5-point Likert scale (1= strongly disagree, 5 = strongly agree) to rate the extent to which they agree with items assessing their supervision attitudes and behaviors (e.g., I let my child take some chances in what he/she does; I have my child within reach at all times). The minimum score on the scale is 29, and the maximum score is 145. Higher scores indicate engagement in higher levels of supervision and greater beliefs about the importance of protecting children from injuries.

    baseline, immediately post-intervention, 1 month post intervention

Secondary Outcomes (1)

  • Injury Frequency Interview

    baseline, immediately post-intervention, 1 month post-intervention

Study Arms (2)

intervention to increase caregiver supervision and reduce child's risk for injury

EXPERIMENTAL

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

Behavioral: SHS

Control group

ACTIVE COMPARATOR

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

Behavioral: Parenting group

Interventions

SHSBEHAVIORAL

Group-based and video-based intervention to teach caregivers of young children how to supervise their children more closely to prevent unintentional injuries.

intervention to increase caregiver supervision and reduce child's risk for injury
Parenting groupBEHAVIORAL

This intervention was designed to teach caregivers about evidence-based behavioral methods to manage common child behavior problems.

Control group

Eligibility Criteria

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

You may qualify if:

  • Spanish speaking caregiver of child ages 15 months to 5 years old.

You may not qualify if:

  • child of caregiver has pervasive develomental disorder, is blink, or deaf.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Michigan University

Kalamazoo, Michigan, 49008, United States

RECRUITING

Study Officials

  • Amy Damashek, Ph.D.

    Western Michigan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Damashek, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2025

First Posted

October 2, 2025

Study Start

May 9, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations