Recruiting

SHS Intervention

Sponsor:

Western Michigan University

Code:

NCT07203612

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

SHS

Parenting group

Study Details

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.

Conditions

Healthy

Study ID

NCT07203612

Start date

May 9, 2024

Status verified date

Sep, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

active comparator: Control group

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

Interventions

SHS

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

Parenting group

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

Primary outcome measure

  • Supervision Behavior [ Time Frame: baseline, immediate post-intervention, 1 month post-intervention ]
  • Parent Supervision Attributes Profile Questionnaire (PSAPQ) [ Time Frame: baseline, immediately post-intervention, 1 month post intervention ]

Central Contacts and Locations

Central contacts

Locations

Western Michigan University

Recruiting

Kalamazoo, Michigan, United States, 49008

Contacts

Principal Investigator:

Amy Damashek, Ph.D.

More Information

Sponsor

Western Michigan University

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western Michigan University on 2025-10-02.