About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Evidence of significant cognitive disability, developmental delay, or pervasive developmental disorder that would prohibit capacity to consent for themselves - Caregivers Only
There are no primary exclusion criteria for the Providers.
There are no primary exclusion criteria for Agency Leaders.
Trial design
Parallel
Treatments tested in this trial
Technology Enhanced Implementation Package
Other interventionThe 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.
SafeCare
Other interventionSafeCare 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Parent-Child Conflict Tactics Scale
The CTS-PC is a 22-item caregiver self-report measure of parenting including neglect, physiological and physical maltreatment of children, and positive disciplinary strategies (e.g., non-violent discipline). Respondents are asked to reflect on their parenting behavior in the past year and rate items on a 7-point scale, with higher scores indicating greater frequency the parenting behavior.
Parenting Stress Inventory
The PSI is a 36-item caregiver self-report scale designed to measure stressors in parenthood. There are three subscales with 12 items each including the dysfunctional interactions subscale, the difficult child subscale, and the parental distress subscale. Caregivers respond on a five-point scale with higher numbers indicating greater parenting stress.
Brief Symptom Inventory
The BSI is a 53-item self-report symptom scale where caregivers will rate how much discomfort the problem presented in the item has caused them in the past seven days on a scale from 0 to 4. The measure includes subscales measuring nine symptoms. The Global Severity Index, a mean of all subscales, was used in this study. Test-retest reliability and internal consistency are very good.
Patient Health Questionnaire
The PHQ-8 is widely used, 8-item screening tool for depression where caregivers will rate 8 symptoms on a four-point descriptive scale from 0 to 3. Criteria validity and internal validity have been established.
Locations
Sponsors and contacts
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Medical University of South Carolina
Lead sponsor
National Institutes of Health (NIH)
Collaborator
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