Pilot Test of Innovative Child Maltreatment (CM) Prevention Strategy

NCT06912685 | Not Yet Recruiting

• 1 other identifier: Pro00141218
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.

Conditions

Parenting Intervention; Maltreatment; Prevention

Keywords

Disease Prevention; Healthy Volunteer Studies; Infant

Outcome Measures

Primary Outcomes (5)

• SafeCare Sick or Injured Child Checklist

  As part of routine SafeCare delivery, providers assess caregiver scores on structured assessments that are part of the Child Health module. Assessments are conducted at the first and last session of this module and scores are recorded in the NSTRC Provider portal. Parents are presented with various health scenarios and respond with actions they would take during those scenarios. Scores represent the percentage of steps reported correctly across all scenarios.

  From the enrollment to the end the Health module, ~6 weeks after starting Health module

• Child Planned Activities Training Checklist

  As part of routine SafeCare delivery, providers assess caregiver scores on structured assessments that are part of the Parent-Child and Parent-Infant Interaction modules. Assessments are conducted at the first and last session of this module and scores are recorded scores in the NSTRC Provider portal. Providers rate parents on the number of interaction skills used during three different interactions with their child, with total scores representing the average percentage of skills used across the three interactions.

  From the enrollment to the end the Parent Child Interaction module, ~6 weeks after starting Parent Child module

• SafeCare Home Observation Checklist

  As part of routine SafeCare delivery, providers assess caregiver scores on structured assessments that are part of the Home Safety module. Assessments are conducted at the first and last session of this module and scores are recorded in the NSTRC Provider portal. Providers assess three commonly used rooms in the home and count the number of accessible safety hazards across all rooms.

  From the enrollment to the end the Safety module, ~6 weeks after starting Safety module

• Brief Child Abuse Potential Inventory

  The BCAP is a 33-item caregiver self-report measure that assesses factors related to child abuse potential and underlying factors related to child abuse risk. The BCAP can be completed in less than 5 minutes, is made up of minimally intrusive items, and is written below a fourth grade reading level. It is a valid and reliable tool for assessing parenting risk.

  Baseline, 3- and 6-month follow up

• Children Services Involvement

  Caregivers will self-report on their interactions with child services during the study period. They will answer questions regarding the number of child welfare referrals received, any child placement changes, and current case status.

  Baseline, 3- and 6-month follow up

Secondary Outcomes (12)

• Parent-Child Conflict Tactics Scale

  Baseline, 3-month and 6-month follow up

• Parenting Stress Inventory

  Baseline, 3-month and 6-month follow up

• Brief Symptom Inventory

  Baseline, 3-month and 6-month follow up

• Patient Health Questionnaire

  Baseline, 3-month and 6-month follow up

• NIDA Quick Screen

  Baseline, 3-month and 6-month follow up

Study Arms (2)

SafeCare as Usual

ACTIVE COMPARATOR

Normal care is SafeCare, an evidence-based home visiting parenting program with three modules focused on child health, home safety, and parent-child relationships. SafeCare sessions typically occur weekly over 18 weeks.

Other: SafeCare

Technology Enhanced Implementation Package (TEIP)

EXPERIMENTAL

The TEIP group will also receive SafeCare and the SafeCare provider will use added guidance on when to use in person or virtual sessions. They will also get access to different support tools, like games or videos, that may be played during online sessions.

Other: Technology Enhanced Implementation Package; Other: SafeCare

Interventions

Technology Enhanced Implementation Package OTHER

The Technology Enhanced Implementation Package for SafeCare delivery consists of protocol adaptations, evidence-informed guidelines, and digital health resources to improve SafeCare outcomes related to reach, quality, and equity.

Technology Enhanced Implementation Package (TEIP)

SafeCare OTHER

SafeCare is an evidence-based home visiting parenting program with three modules focused on child health, home safety, and parent-child relationships. SafeCare sessions typically occur weekly over 18 weeks.

SafeCare as Usual; Technology Enhanced Implementation Package (TEIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• English language proficiency
• Ability to provide informed consent for themselves
• Has at least one child between the ages of 0-5 years old - Caregivers Only
• Has completed at least 1 module of SafeCare since April 2021 - Caregivers Only
• SafeCare enrollment has been completed (e.g., not currently enrolled in SafeCare). - Caregivers Only
• Current employment at a SafeCare agency - Agency Leaders Only
• Full- or part-time employment at a SafeCare agency - Providers Only
• Must be fully certified to provide SafeCare services - Providers Only
• Must be providing services for at least 6 months - Providers Only

You may not qualify if:

• Evidence of significant cognitive disability, developmental delay, or pervasive developmental disorder that would prohibit capacity to consent for themselves - Caregivers Only

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator

Study Officials

• Hannah Espeleta

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Recruitment Contact

CONTACT

(843) 792-4202; becerra@musc.edu

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: Research Assistant Professor-Faculty

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: April 6, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share