About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Caregiver is age 18 years or older
Caregiver is English or Spanish Speaking
Caregiver is legal guardian of child subject
Caregiver provides informed consent
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
PriCARE/CARIÑO
BehavioralPriCARE/CARIÑO is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE/CARIÑO uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving effective commands in order to set age-appropriate limits and increase compliance. PriCARE/CARIÑO includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. CARIÑO is the culturally adapted version of PriCARE for Spanish speaking participants.
Treatment groups
Trial outcomes
Primary outcomes
Child Protective Services Investigations from time 3 to time 5
The primary outcome variable is a binary indicator of whether or not the child experienced at least one investigation from Child Protective Services (CPS) during follow-up. Beginning 4 months after randomization, each child will be followed for a period of 12 to 48 months to document all CPS investigations of suspected child maltreatment. The length of the follow-up interval will depend on the dyad's time of enrollment in the study.
Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4
Change in BCAP scores from time 1 to time 4 will be measured. BCAP, a 34-item survey, measures traits and parenting styles typical of known physical child abusers. Each item has a unweighted value based on if agree vs. disagree is chosen and then the values are summed. Child abuse risk scores range from 0-24 with higher scores indicating caregiver has traits similar to those of known child abusers and has a higher risk of abuse.
Secondary outcomes
Change in the Eyberg Child Behavior Inventory (ECBI) intensity scale score from time 1 to time 4
The investigators will assess the efficacy of PriCARE/CARIÑO on decreasing caregiver-reported child behavior problems as measured by the ECBI. The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years old. The instrument contains 36 items that assess behavior on two scales. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes.
Change in the Eyberg Child Behavior Inventory (ECBI) problem scale score from time 1 to time 4
The investigators will assess the efficacy of PriCARE/CARIÑO on decreasing caregiver-reported child behavior problems as measured by the ECBI. The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years old. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. Higher scores indicate worse outcomes.
Change in the number of child led play skills in the Dyadic Parent-Child Interaction Coding System (DPICS) from time 1 to time 4
Investigators will assess the efficacy of PriCARE/CARIÑO on impacting the quality of the caregiver-child relationship with the DPICS. Each dyad is observed during two 5-minute standard situations: child-led play and clean-up. The coding manual has definitions, examples, and guidelines for deciding how to code the 24 standard caregiver and child behaviors. The interactions are video-recorded and coded by a blinded research assistant. Zero, or not observed, is the minimum for all behaviors, and there is not set maximum. A second research assistant re-codes 10% of randomly selected videos to check for coding reliability. Child led play skills are reflective statement, descriptive statement, labeled praise and unlabeled praise. Positive change (increase) in the number child-led play skills indicates better outcomes.
Change in the number of non-child led skill in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
Non-child led skills are question, commands and negative talk. Zero, or not observed, is the minimum and there is no set maximum. Negative change (decrease) in number of non-child led skills indicates better outcomes.
Sponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Children's Hospital of Philadelphia
Collaborator