Child-Adult Relationship Enhancement for Parent-Child Relationships

Recruiting at 1 trial location

Overseen By Samantha Schilling, MD, MSHP

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Behavioral health medications

Disqualifiers: Autism, Behavioral treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

1932 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a program called PriCARE/CARIÑO can improve relationships between caregivers and their young children. The goal is to determine if this program can reduce harsh or neglectful parenting, lower caregiver stress, and assist with challenging child behaviors. Participants will either receive PriCARE/CARIÑO sessions along with their usual care or continue with just their usual care. Ideal participants are caregivers with legal guardianship of a child aged 18 months to 6 years, residing in North Carolina or Philadelphia, and willing to attend weekly sessions for six weeks. As an unphased trial, this study offers caregivers a unique opportunity to contribute to valuable research that could enhance family dynamics and child development.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if the child is receiving medication for a behavioral health problem, they cannot participate.

What prior data suggests that PriCARE/CARIÑO is safe for parent-child relationships?

Research has shown that PriCARE/CARIÑO is a 6-session group program designed to improve parent-child relationships. Unlike medical treatments involving drugs or surgeries, this behavioral program teaches skills in a supportive environment, making it generally safe for participants. Studies have not identified any negative side effects from this type of program.

The trial is labeled as "not applicable" in phase, indicating a focus on training and education rather than testing a new drug. Therefore, the safety concerns typical of drug trials do not apply. Participants can expect a safe setting aimed at improving family interactions without physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PriCARE/CARIÑO because it offers a fresh approach to enhancing parent-child relationships, focusing on skill-building and direct interaction. Unlike traditional methods that might rely heavily on therapy sessions or medication, this intervention emphasizes practical skills that caregivers can apply immediately with their children. Meeting weekly in small groups guided by mental health professionals, caregivers learn and practice these relationship-strengthening techniques, aiming for noticeable improvements in just six weeks. This hands-on, interactive approach sets it apart from more conventional treatments, offering a potentially quicker and more engaging path to improving family dynamics.

What evidence suggests that PriCARE/CARIÑO is effective for improving parent-child relationships?

Research shows that PriCARE/CARIÑO, one of the interventions in this trial, is a promising program for improving parent-child relationships. Studies have found that it can help reduce parenting stress. This program also strengthens the bond between parents and children. By focusing on these areas, PriCARE/CARIÑO aims to reduce harsh or neglectful parenting and improve children's behavior. Overall, these findings suggest that the program could effectively reduce child maltreatment and enhance family dynamics. Participants in this trial may receive PriCARE/CARIÑO alongside usual care, while others will receive usual care alone. ^{1 2 4 5 6}

Who Is on the Research Team?

Samantha Schilling, MD, MSHP

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for caregivers over 18 with a child aged 2-6 who live in North Carolina or Philadelphia. The child must have Medicaid/CHIP/no insurance, and the caregiver needs to be able to text and attend virtual sessions. Caregivers can't join if they've done PriCARE/CARIÑO before or if their child is getting other behavioral treatments.

Inclusion Criteria

My child is between 2 and 6 years old.

Caregiver has appropriate technological tools and access to participate in virtual intervention

Child receives care at participating primary care center

Exclusion Criteria

My child is currently getting treatment or medication for a behavioral issue.

Caregiver or another caregiver in the household has previously participated in PriCARE/CARIÑO

Child has a diagnosis of or is being evaluated for autism or Oppositional Defiant Disorder (ODD)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregiver-child dyads receive the PriCARE/CARIÑO intervention for 6 weeks, with weekly sessions administered by trained mental health professionals.

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in child maltreatment risk, parenting attitudes, and child behavior. CPS investigations are tracked.

6-8 months

Extended Follow-up

CPS investigations are collected starting 4 months after randomization until the end of the study, up to 52 months.

up to 52 months

What Are the Treatments Tested in This Trial?

Interventions

• PriCARE/CARIÑO

Trial Overview PriCARE/CARIÑO program is being tested for its ability to reduce child maltreatment, improve parent-child interactions, lessen harsh parenting practices, decrease parental stress, and mitigate challenging behaviors in children.

How Is the Trial Designed?

Group I: PriCARE/CARIÑO plus Usual Care Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 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 Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

The PriCARE program, which teaches positive parenting skills, effectively improved child behavior and parenting practices in preschool-aged children, as shown by significant reductions in behavior problem scores compared to a control group.

Incorporating a peer mentor into the PriCARE program reduced stigma among parents, although it did not significantly increase attendance at the sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child-Adult Relationship Enhancement in Primary Care: A Randomized Trial of a Skill-Based Parent Training with Parent Mentor Adaptation. Schilling, S., Ritter, V., Wood, JN., et al.[2021]

The PriCARE intervention, which is designed to improve parenting skills and reduce child behavior problems, has shown effectiveness in three randomized controlled trials, making it a promising option for integration into pediatric primary care.

By implementing five synergistic strategies to enhance physician referrals, the referral rate for the PriCARE intervention significantly increased from 13% to 55%, demonstrating the potential for effective dissemination of parenting interventions in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and applying synergistic multilevel implementation strategies to promote reach of an evidence-based parenting intervention in primary care. Schilling, S., Bigal, L., Powell, BJ.[2023]

The Cariño program, a culturally adapted version of the PriCARE parenting program, was developed specifically for Spanish-speaking Hispanic parents, incorporating culturally relevant concepts to enhance its applicability and acceptance.

Pilot results showed that 62% of enrolled participants attended at least 4 out of 6 sessions, with high satisfaction ratings, indicating that the program is both feasible and well-received by the target audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Criando Niños Con Cariño : Primary Care-Based Group Parenting Program Adaptation and Pilot. Schilling, S., Romero-Cely, D., Mebane, A., et al.[2023]

The PriCARE program, a 6-session group parent training, significantly reduced child behavior problems in preschool-aged children, with greater improvements in behavior scores compared to a control group.

Parents who participated in PriCARE also showed enhanced positive parenting attitudes, particularly in empathy towards children's needs and reduced reliance on corporal punishment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child-Adult Relationship Enhancement in Primary Care (PriCARE): A Randomized Trial of a Parent Training for Child Behavior Problems. Schilling, S., French, B., Berkowitz, SJ., et al.[2019]

The PriCARE/CARIÑO intervention is a promising 6-session parenting program designed to improve parent-child relationships and reduce child maltreatment (CM) risk, specifically targeting low-income and minority families through primary care settings.

This multicenter randomized controlled trial will assess the effectiveness of PriCARE/CARIÑO by measuring the occurrence of CM investigations and various secondary outcomes over 48 months, making it the largest trial of its kind to explore mechanisms of change in CM prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Schilling, S., Powell, BJ., Stewart, PW., et al.[2023]

In a multisite study involving 119 caregivers of children aged 2 to 6 with behavioral concerns, the PriCARE intervention significantly reduced perceived child behavior problems and parenting stress compared to a waitlist control group.

While PriCARE effectively improved caregivers' perceptions of child behavior severity and reduced parenting stress, it did not lead to significant changes in parenting attitudes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Child Behaviors and Parental Stress: A Randomized Trial of Child Adult Relationship Enhancement in Primary Care. Wood, JN., Kratchman, D., Scribano, PV., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11194740/

Child Adult Relationship Enhancement in Primary Care ... PriCARE has also been shown to reduce parenting-related stress. Finally, by strengthening and bringing warmth to the parent-child relationship, ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-07024-y

Child Adult Relationship Enhancement in Primary Care ... PriCARE/Criando Niños con CARIÑO is a 6-session group parenting intervention that holds promise in addressing these challenges.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1538544223002043

A promising intervention to reduce child maltreatment PriCARE has also been shown to reduce parenting-related stress. Finally, by strengthening and bringing warmth to the parent-child relationship, PriCARE may ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36823526/

study design/protocol for a randomized trial of a primary care ... PriCARE/Criando Niños con CARIÑO is a 6-session group parenting intervention that holds promise in addressing these challenges.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05233150/child-adult-relationship-enhancement-in-primary-care-pricare-criando-ninos-con-carino-carino

Child-Adult Relationship Enhancement in Primary Care ... The purpose of this study is evaluate the effectiveness of PriCARE/CARIÑO to reduce child maltreatment, improve parent-child interactions, and ...

6. researchgate.net researchgate.net/publication/368754131_Child_Adult_Relationship_Enhancement_in_Primary_Care_PriCARE_study_designprotocol_for_a_randomized_trial_of_a_primary_care-based_group_parenting_intervention_to_prevent_child_maltreatment

(PDF) Child Adult Relationship Enhancement in Primary ... Child Adult Relationship Enhancement in Primary Care (PriCARE)/Criando Niños con CARIÑO is a 6-session group parenting intervention that holds promise in ...