Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO) (NCT05233150) | Clinical Trial Compass
RecruitingNot Applicable
Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
United States1,932 participantsStarted 2022-05-18
Plain-language summary
The purpose of this study is evaluate the effectiveness of PriCARE/CARIÑO to reduce child maltreatment, improve parent-child interactions, and reduce harsh/neglectful parenting, parent stress, and child behaviors.
Who can participate
Age range
18 Months – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Caregiver is age 18 years or older
* Caregiver is English or Spanish Speaking
* Caregiver is legal guardian of child subject
* Caregiver provides informed consent
* Caregiver is available to attend scheduled times of PriCARE/CARIÑO groups
* Caregiver has cellular phone with text messaging capacity
* Caregiver has appropriate technological tools and access to participate in virtual intervention
* Child is between 18 months and 6 years old
* Child receives care at participating primary care center
* Child has Medicaid/Children's Health Insurance Program (CHIP)/no insurance
* Child lives in North Carolina or Philadelphia
Exclusion Criteria:
* Caregiver or another caregiver in the household has previously participated in PriCARE/CARIÑO
* Child has a cognitive functioning below 2-year-old level, as determined by the screening questions and/or the referring clinician
* Child has a diagnosis of autism
* Child is receiving individual behavioral health treatment or medication for a behavioral health problem
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Child Protective Services Investigations from time 3 to time 5
Timeframe: 4 month after baseline (time 3) up to 52 months after baseline (time 5)
2
Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4
Timeframe: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)