Parenting Intervention(CM)NCT06912685
Early Test of an Innovative Child Maltreatment (CM) Prevention Strategy
A study testing Technology Enhanced Implementation Package and SafeCare in people with Parenting Intervention and Maltreatment, run by Medical University of South Carolina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting Intervention, Maltreatment, Prevention
- What is being tested?
- Technology Enhanced Implementation Package and SafeCare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention
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.
Read the detailed description
Child maltreatment (CM) is a public health priority, affecting millions of children each year. Evidence-based home visiting (HV) models are gold standard CM prevention programs that intervene on modifiable risk factors. Despite their effectiveness and national implementation, HV is resource intensive which limits their potential reach and impact. HV programs serve only 3% of high-risk families, with limited access for minoritized and rural-dwelling families. Rigorous research is needed to guide approaches to implementing HV to ensure agencies can deliver the highest-quality care with more accessibility and equity without compromising child safety. Preliminary data during the COVID-19 pandemic offered insight to the benefits of virtual, telehealth-based visits for CM prevention and enabled service agencies to observe that quality and safety concerns can be managed in most cases. The consensus of experts and HV providers is that hybrid, telehealth leveraged HV implementation can enhance access, quality, and efficiency of CM prevention models. Moreover, technology-based supports are needed to engage families, drive skill acquisition, support model fidelity, and improve accuracy in safety and skill assessment. Through an institutional KL2 award (PI: Espeleta), leveraging community advisory boards, secondary data analysis of clinical services data, and user-centered design methods, I am developing a telehealth-compatible, technology-enhanced, hybrid in-person/virtual implementation package for CM prevention. This package will consist of protocol adaptations, evidence-informed guidelines, and digital health resources to improve implementation outcomes related to reach, quality, and equity. However, the KL2 does not include a pilot RCT, which is essential to establish the feasibility of the implementation package as well as the RCT methodology in preparation for a future R01. The project's goals are to 1) Refine and preliminarily evaluate the TEIP and the feasibility of the research methodology with 12 providers and 40 families; and 2) Assess implementation factors related to the TEIP including its usability, acceptability, and feasibility with key constituents. Findings will inform a future R01 submission to evaluate the hybrid HV/virtual implementation on dimensions of equitable reach, effectiveness, implementation, and maintenance.
- Conditions
- Parenting Intervention, Maltreatment, Prevention
- Being tested
- Technology Enhanced Implementation Package, SafeCare
- Keywords
- Disease Prevention, Healthy Volunteer Studies, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Enhanced Implementation PackageOther
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.
SafeCareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Technology Enhanced Implementation Package; Other: SafeCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3- and 6-month follow up
Secondary outcomes (12)
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.
Measured: Baseline, 3-month and 6-month follow up
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.
Measured: Baseline, 3-month and 6-month follow up
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.
Measured: Baseline, 3-month and 6-month follow up
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.
Measured: Baseline, 3-month and 6-month follow up
NIDA Quick Screen
The NIDA Quick screen consists of four questions regarding the frequency of which respondents have used illegal drugs, prescription drugs for non-medical reasons, tobacco, or multiple drinks containing alcohol.
Measured: Baseline, 3-month and 6-month follow up
Social Provisions Scale
The SPS is a 12-item self-report scale designed to measure overall perceived social support for adults.
Measured: Baseline, 3-month and 6-month follow up
Protective Factors Survey
The PFS assesses five protective factors for child maltreatment including parenting knowledge, nurturing behaviors, and family functioning. Each domain includes four or five items and caregivers respond on a seven-point scale.
Measured: Baseline, 3-month and 6-month follow up
Family Resource Scale
The FRS-revised is a 30-item self-report measure of the adequacy of resources in households with children. Items load on seven scales corresponding to income, childcare, communication/employment, intrafamily support, physical shelter, nutrition/protection, health/necessities, and growth/social support.
Measured: Baseline, 3-month and 6-month follow up
The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool
The AHC HRSN screening tool is a 10-item self-report tool to help identify respondent needs on 5 core domains of housing instability, food insecurity, transportation problems, utility help needs, and interpersonal safety.
Measured: Baseline, 3-month and 6-month follow up
Client Satisfaction Survey
The Client Satisfaction Survey is a short rating scale that assesses caregiver satisfaction with SafeCare content, the usefulness of training strategies and target skills, technology used during training, and a general rating of the home visitor. Items are rated on a. 5-point scale. Surveys are submitted by caregivers online following each SafeCare module completed.
Measured: 3-month follow up
Client Cultural Competency Inventory
The CCCI is a caregiver self-report instrument reflecting their perception of the cultural competency of services. The instrument has a low susceptibility to social desirability bias and good internal consistency and temporal stability and has been used in mental health services utilization research.
Measured: 3-month follow up
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure
The AIM, IAM, and FIM measure is a self-report measure consisting of 15 items (5 items pers scale) that range from "completely disagree" to "completely agree." This measure can be tailored to your specific intervention to gather feedback on its acceptability, appropriateness, and feasibility
Measured: 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting InterventionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hannah Espeleta, Medical University of South Carolina
- Investigators
- Hannah Espeleta, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912685
- Sponsor's protocol ID
- Pro00141218
- Acronym
- (CM)
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention
- ClinicalTrials.gov ID
- NCT06912685
- Acronym / sponsor ID
- (CM) / Pro00141218
- Conditions
- Parenting Intervention, Maltreatment, Prevention
- Keywords
- Disease Prevention, Healthy Volunteer Studies, Infant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Child maltreatment (CM) is a public health priority, affecting millions of children each year. Evidence-based home visiting (HV) models are gold standard CM prevention programs that intervene on modifiable risk factors. Despite their effectiveness and national implementation, HV is resource intensive which limits their potential reach and impact. HV programs serve only 3% of high-risk families, with limited access for minoritized and rural-dwelling families. Rigorous research is needed to guide approaches to implementing HV to ensure agencies can deliver the highest-quality care with more accessibility and equity without compromising child safety. Preliminary data during the COVID-19 pandemic offered insight to the benefits of virtual, telehealth-based visits for CM prevention and enabled service agencies to observe that quality and safety concerns can be managed in most cases. The consensus of experts and HV providers is that hybrid, telehealth leveraged HV implementation can enhance access, quality, and efficiency of CM prevention models. Moreover, technology-based supports are needed to engage families, drive skill acquisition, support model fidelity, and improve accuracy in safety and skill assessment. Through an institutional KL2 award (PI: Espeleta), leveraging community advisory boards, secondary data analysis of clinical services data, and user-centered design methods, I am developing a telehealth-compatible, technology-enhanced, hybrid in-person/virtual implementation package for CM prevention. This package will consist of protocol adaptations, evidence-informed guidelines, and digital health resources to improve implementation outcomes related to reach, quality, and equity. However, the KL2 does not include a pilot RCT, which is essential to establish the feasibility of the implementation package as well as the RCT methodology in preparation for a future R01. The project's goals are to 1) Refine and preliminarily evaluate the TEIP and the feasibility of the research methodology with 12 providers and 40 families; and 2) Assess implementation factors related to the TEIP including its usability, acceptability, and feasibility with key constituents. Findings will inform a future R01 submission to evaluate the hybrid HV/virtual implementation on dimensions of equitable reach, effectiveness, implementation, and maintenance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SafeCare as Usual | Active comparator | Other: SafeCareNormal 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. |
| Technology Enhanced Implementation Package (TEIP) | Experimental | Other: Technology Enhanced Implementation Package, Other: SafeCareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology Enhanced Implementation PackageThe 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. | Other | Technology Enhanced Implementation Package (TEIP) |
| SafeCareSafeCare 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. | Other | SafeCare as Usual, Technology Enhanced Implementation Package (TEIP) |
Primary outcome
SafeCare Sick or Injured Child Checklist
Time frame: From the enrollment to the end the Health module, ~6 weeks after starting Health module
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
Time frame: From the enrollment to the end the Parent Child Interaction module, ~6 weeks after starting Parent Child module
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
Time frame: From the enrollment to the end the Safety module, ~6 weeks after starting Safety module
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
Time frame: Baseline, 3- and 6-month follow up
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.
Children Services Involvement
Time frame: Baseline, 3- and 6-month follow up
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.
12 secondary outcomes
Parent-Child Conflict Tactics Scale
Time frame: Baseline, 3-month and 6-month follow up
Parenting Stress Inventory
Time frame: Baseline, 3-month and 6-month follow up
Brief Symptom Inventory
Time frame: Baseline, 3-month and 6-month follow up
Patient Health Questionnaire
Time frame: Baseline, 3-month and 6-month follow up
NIDA Quick Screen
Time frame: Baseline, 3-month and 6-month follow up
Social Provisions Scale
Time frame: Baseline, 3-month and 6-month follow up
Protective Factors Survey
Time frame: Baseline, 3-month and 6-month follow up
Family Resource Scale
Time frame: Baseline, 3-month and 6-month follow up
The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool
Time frame: Baseline, 3-month and 6-month follow up
Client Satisfaction Survey
Time frame: 3-month follow up
Client Cultural Competency Inventory
Time frame: 3-month follow up
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure
Time frame: 3-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah Espeleta principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Technology Enhanced Implementation Package and SafeCare in people with Parenting Intervention and Maltreatment, run by Medical University of South Carolina.
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 10 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Recruitment Contact ((843) 792-4202, becerra@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SafeCare Sick or Injured Child Checklist (time frame: From the enrollment to the end the Health module, ~6 weeks after starting Health module). The study lists 5 primary outcomes in all. 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 13 Jul 2026.