Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-28 @ 6:34 AM
Study NCT ID:
NCT05233150
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The primary objective of this study is to evaluate the effectiveness of PriCARE/CARIÑO to reduce investigations of suspected Child Maltreatment (CM) by Child Protective Services (CPS), and CM risk as measured by the Brief Child Abuse Potential Inventory (BCAP).
The secondary objectives of this study are to measure the impact of PriCARE/CARIÑO on:
1. Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI).
2. The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS).
3. Parenting stress as measured by the Parenting Stress Index-Short From (PSI).
4. Harsh parenting as measured by Conflict Tactics Scales, Parent-Child version (CTS) and the Parenting Scale (PS)
The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the PriCARE/CARIÑO on objectives listed above among 2- to 6-year-old children and their parents at 3 Children's Hospital of Philadelphia (CHOP) Primary Care Centers and 10 pediatric clinics in North Carolina. The investigators intend to randomize 966 child-caregiver dyads (1932 subjects) to receive PriCARE/CARIÑO plus usual care (intervention group) and 966 child-parent dyads (1932 subjects) to receive usual care (control group). CM risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline and approximately 6-8 months after randomization for both the intervention and control groups. CPS investigations will be collected starting 4 months after randomization until the end of the study (up to 52 months).
The secondary objectives of this study are to measure the impact of PriCARE/CARIÑO on:
1. Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI).
2. The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS).
3. Parenting stress as measured by the Parenting Stress Index-Short From (PSI).
4. Harsh parenting as measured by Conflict Tactics Scales, Parent-Child version (CTS) and the Parenting Scale (PS)
The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the PriCARE/CARIÑO on objectives listed above among 2- to 6-year-old children and their parents at 3 Children's Hospital of Philadelphia (CHOP) Primary Care Centers and 10 pediatric clinics in North Carolina. The investigators intend to randomize 966 child-caregiver dyads (1932 subjects) to receive PriCARE/CARIÑO plus usual care (intervention group) and 966 child-parent dyads (1932 subjects) to receive usual care (control group). CM risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline and approximately 6-8 months after randomization for both the intervention and control groups. CPS investigations will be collected starting 4 months after randomization until the end of the study (up to 52 months).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD103902-01 | NIH | None | https://reporter.nih.gov/quic… | View |