Parent-Child RelationsNCT05233150
Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
A study testing PriCARE/CARIÑO in people with Parent-Child Relations and Child Maltreatment, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Child Maltreatment
- What is being tested?
- PriCARE/CARIÑO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,932 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 May 2022to 1 Jul 2027
- 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 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Samantha Schilling, MD, MSHP, 919-966-2504, samantha_schilling@med.unc.edu
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Joanne Wood, MD, MSHP, 267-426-3107, woodjo@chop.edu
About this study
Official title: Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
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.
Read the 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:
- Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI).
- The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS).
- Parenting stress as measured by the Parenting Stress Index-Short From (PSI).
- 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).
- Conditions
- Parent-Child Relations, Child Maltreatment
- Being tested
- PriCARE/CARIÑO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriCARE/CARIÑOBehavioural
Also called Child Adult Relationship Enhancement in Primary Care, Criando Niños con CARIÑO
PriCARE/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.
| Study group | Role | What they receive |
|---|---|---|
| PriCARE/CARIÑO plus Usual Care | Experimental | Caregiver-child dyads assigned to the PriCARE/CARIÑO plus usual care group will receive the PriCARE/CARIÑO intervention within 4 months of randomization plus usual care. The intervention will last 6 weeks. Each group, administered by 1-2 trained mental health professionals, will have approximately 4-10 caregiver participants and will meet weekly for 6 weeks. Each of the 6 sessions is approximately 80 minutes. Caregivers are expected to practice the skills they learn with their children between sessions. Receives: Behavioral: PriCARE/CARIÑO |
| Usual care | No intervention | Caregiver-child dyads assigned to the usual care group will receive usual care and will not be aware of being in a group of about 8-10 recently-enrolled subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 month after baseline (time 3) up to 52 months after baseline (time 5)
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.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Secondary outcomes (18)
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.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
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.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
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.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
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.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the number of direct commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
Zero, or not observed, is the minimum and there is no set maximum. Positive change (increase) in number of direct commands indicates better outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the number child's compliance with commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
Zero, or not observed, is the minimum and there is no set maximum. Positive change (increase) in number of child's compliance with commands indicates better outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) total score from time 1 to time 4
PSI is a 36-item symptom inventory that identifies caregiver-child dyads who are experiencing stress and at risk for dysfunctional parenting and behavior problems. There are 3 subscales: Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child. Questions are answered on a 5-point Likert scale with ("strongly agree", "not sure", "agree", etc.). The total score range is 36-180. Higher scores indicate worse outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) Parental Distress subscale score from time 1 to time 4
There are 12 items in the Parental Distress subscale. Questions are answered on a 5-point Likert scale with ("strongly agree", "not sure", "agree", etc.). The score range for this subscale is 12-60. Higher scores indicate worse outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) Parent-Child Dysfunctional Interaction subscale score from time 1 to time 4
There are 12 items in the Parent-Child Dysfunctional Interaction subscale. Questions are answered on a 5-point Likert scale with ("strongly agree", "not sure", "agree", etc.). The score range for this subscale is 12-60. Higher scores indicate worse outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) Difficult Child subscale score from time 1 to time 4
There are 12 items in the Difficult Child subscale. Questions are answered on a 5-point Likert scale with ("strongly agree", "not sure", "agree", etc.). The score range for this subscale is 12-60. Higher scores indicate worse outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Nonviolent Discipline score from time 1 to time 4
Conflict Tactics Scales Parent-Child (CTS-PC) is a 35-item scale focusing on the respondent's behavior with their child including discipline methods. CTS-PC quantifies the level of abuse in families in multiple domains. In this study, the investigators will include the 19-items that constitute the nonviolent discipline, psychological aggression, minor physical assault, and weekly discipline subscales. Scores for each subscale will be calculated.
There are 5 items in the Nonviolent Discipline subscale, and the score ranges 0-125. Higher scores indicate better outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Psychological Aggression score from time 1 to time 4
There are 5 items in the Psychological aggression subscale and scores ranges 0-125. Higher scores indicate worse outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Minor Physical Assault score from time 1 to time 4
There are 6 items in the Minor Physical Assault subscale and scores ranges 0-150. Higher scores indicate worse outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Weekly Discipline score from time 1 to time 4
There are 3 items in the Weekly Discipline subscale and scores ranges 0-75. Higher scores indicate worse outcomes.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) total score from time 1 to time 4
PS is a 30-item self-report questionnaire designed to assess dysfunctional parenting discipline strategies including laxness (permissive inconsistent discipline, providing positive consequences for misbehavior), over-reactivity (harsh, emotional, authoritarian discipline characterized by irritability), and hostility (use of verbal or physical force). Total score is calculated as an average across all 30 items (range: 1-7). Higher scores reflect more problematic parenting.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) Laxness subscale score from time 1 to time 4
There are 5 items in the Laxness subscale. Scores are calculated as an average across 5 items (range: 1-7). Higher scores reflect more problematic parenting.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) Over-Reactivity subscale score from time 1 to time 4
There are 5 items in the Over-Reactivity subscale. Scores are calculated as an average across 5 items (range: 1-7). Higher scores reflect more problematic parenting.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) Hostility subscale score from time 1 to time 4
There are 3 items in the Hostility subscale. Scores are calculated as an average across 3 items (range: 1-7). Higher scores reflect more problematic parenting.
Measured: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start18 May 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,932 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Samantha Schilling, MD, MSHP, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233150
- Sponsor's protocol ID
- 20-2605
- Other IDs
- 1R01HD103902-01
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data collected during the trial will be made available beginning 36 months (3 years) following article (primary aim) publication and ending 60 months (5 years) following article publication. The study protocol will also be made available. Data will be shared for the purpose of individual participant data meta-analysis. Data will be shared with researchers who (1) provide a methodologically sound proposal that focuses on meta-analysis, (2) have obtained IRB approval for the proposal, and (3) execute a data use agreement. Proposals should be directed to Samantha\_Schilling@med.unc.edu and Woodjo@chop.edu
Publications
Andom F, Wood JN, Jiang L, Lin FC, Schilling S. Bridging access and impact: primary care parenting intervention reduces early behavior problems in both virtual and in-person delivery modes. Front Pediatr. 2026 Feb 11;14:1709280. doi: 10.3389/fped.2026.1709280. eCollection 2026.
PubMed 41756184Schilling S, Powell BJ, Stewart PW, Wood JN. Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment. Trials. 2023 Feb 23;24(1):138. doi: 10.1186/s13063-022-07024-y.
PubMed 36823526
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
- ClinicalTrials.gov ID
- NCT05233150
- Acronym / sponsor ID
- 20-2605
- Conditions
- Parent-Child Relations, Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,932 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia
- Study start
- 18 May 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Feb 2022 (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.
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:
- Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI).
- The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS).
- Parenting stress as measured by the Parenting Stress Index-Short From (PSI).
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PriCARE/CARIÑO plus Usual Care | Experimental | Behavioral: PriCARE/CARIÑOCaregiver-child dyads assigned to the PriCARE/CARIÑO plus usual care group will receive the PriCARE/CARIÑO intervention within 4 months of randomization plus usual care. The intervention will last 6 weeks. Each group, administered by 1-2 trained mental health professionals, will have approximately 4-10 caregiver participants and will meet weekly for 6 weeks. Each of the 6 sessions is approximately 80 minutes. Caregivers are expected to practice the skills they learn with their children between sessions. |
| Usual care | No intervention | –Caregiver-child dyads assigned to the usual care group will receive usual care and will not be aware of being in a group of about 8-10 recently-enrolled subjects. |
Who may qualify
- Ages
- 18 months to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| PriCARE/CARIÑOAlso: Child Adult Relationship Enhancement in Primary Care, Criando Niños con CARIÑOPriCARE/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. | Behavioural | PriCARE/CARIÑO plus Usual Care |
Primary outcome
Child Protective Services Investigations from time 3 to time 5
Time frame: 4 month after baseline (time 3) up to 52 months after baseline (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
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (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.
18 secondary outcomes
Change in the Eyberg Child Behavior Inventory (ECBI) intensity scale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Eyberg Child Behavior Inventory (ECBI) problem scale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the number of child led play skills in the Dyadic Parent-Child Interaction Coding System (DPICS) from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the number of non-child led skill in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the number of direct commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the number child's compliance with commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) total score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) Parental Distress subscale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) Parent-Child Dysfunctional Interaction subscale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Stress Index-Short Form (PSI) Difficult Child subscale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Nonviolent Discipline score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Psychological Aggression score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Minor Physical Assault score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Weekly Discipline score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) total score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) Laxness subscale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) Over-Reactivity subscale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in the Parenting Scale (PS) Hostility subscale score from time 1 to time 4
Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
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 1 May 2026.
- Derived from this study: PubMed 41756184Andom F, Wood JN, Jiang L, Lin FC, Schilling S. Bridging access and impact: primary care parenting intervention reduces early behavior problems in both virtual and in-person delivery modes. Front Pediatr. 2026 Feb 11;14:1709280. doi: 10.3389/fped.2026.1709280. eCollection 2026.
- Derived from this study: PubMed 36823526Schilling S, Powell BJ, Stewart PW, Wood JN. Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment. Trials. 2023 Feb 23;24(1):138. doi: 10.1186/s13063-022-07024-y.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data collected during the trial will be made available beginning 36 months (3 years) following article (primary aim) publication and ending 60 months (5 years) following article publication. The study protocol will also be made available. Data will be shared for the purpose of individual participant data meta-analysis. Data will be shared with researchers who (1) provide a methodologically sound proposal that focuses on meta-analysis, (2) have obtained IRB approval for the proposal, and (3) execute a data use agreement. Proposals should be directed to Samantha_Schilling@med.unc.edu and Woodjo@chop.edu
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Active, not recruiting
Pediatric Parenting Support in Flint
Healthy, Family Research
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Not yet recruitingObservational study
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
Anxiety
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
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.
Samantha Schilling, MD, MSHP principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PriCARE/CARIÑO in people with Parent-Child Relations and Child Maltreatment, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Samantha Schilling, MD, MSHP (919-966-2504, samantha_schilling@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Protective Services Investigations from time 3 to time 5 (time frame: 4 month after baseline (time 3) up to 52 months after baseline (time 5)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233150, which also lists 2 linked publications.
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 1 May 2026.