Positive Parenting Program for Child Behavioral Disorders in Foster Care

Overseen By Edna Terry

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Completed CARE or PriCARE training

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called PriCARE (Positive Parenting Program) to determine if it helps foster parents improve parenting skills and increase empathy toward children. The study targets foster caregivers with children aged 18 months to 6 years, aiming to promote positive relationships and better behavior in kids. Participants will attend group sessions led by mental health professionals, totaling around nine hours over several weeks. English-speaking foster caregivers who have not previously completed similar training might be a good fit for this trial. As an unphased trial, this study offers foster caregivers a unique opportunity to enhance their parenting skills and positively impact their children's lives.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the PriCARE program is safe for foster caregivers?

Research has shown that PriCARE improves parenting skills and strengthens the bond between parents and children. Studies suggest it can lower the risk of child abuse, aiming to create a positive and nurturing environment for kids.

Since PriCARE focuses on behavior rather than medication, it avoids typical drug-related safety concerns like side effects. Instead, it involves group sessions led by trained mental health professionals, helping caregivers learn empathy and positive parenting.

PriCARE has been used in other studies to assist caregivers with challenges and has shown promise, indicating the program is generally well-received. Participants can expect a supportive environment where they learn effective parenting techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PriCARE program because it offers a unique approach to addressing child behavioral disorders in foster care. Unlike traditional methods that often focus solely on the child, PriCARE emphasizes strengthening the caregiver-child relationship through group training sessions. This approach not only helps caregivers develop effective parenting strategies but also fosters a supportive community among caregivers, which can lead to more sustainable positive outcomes. By involving mental health professionals in the training, PriCARE ensures that caregivers receive expert guidance tailored to the specific challenges of fostering children with behavioral issues.

What evidence suggests that PriCARE is effective for child behavioral disorders in foster care?

Research has shown that PriCARE, the program tested in this trial, is a promising approach for improving parenting skills and reducing the risk of child abuse or neglect. Studies have found that PriCARE enhances parent-child interactions, leading to more positive behaviors. In this trial, all participants will join a PriCARE group program, typically held over six sessions, to help parents connect better with their children. Early results suggest that PriCARE helps caregivers become more empathetic and understanding in their parenting roles. By focusing on positive parenting techniques, PriCARE aims to create healthier family relationships, especially for children in foster care. ^{1 2 4 6 7}

Who Is on the Research Team?

Joanne Wood, MD, MSHP

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for foster caregivers over 18 years old who speak English and are parenting a foster child aged between 2 to 10. They must be willing to give informed consent to participate in the study.

Inclusion Criteria

Caregiver is a foster parent of a foster child between 2 and 10 years of age

English-speaking

Foster caregiver provides informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial interview conducted to obtain baseline data regarding demographic information, parenting attitudes, and parenting strategies

1 week

1 visit (in-person)

PriCARE Training

Participants attend PriCARE training sessions led by mental health providers

2-20 weeks

2-6 sessions (in-person)

Follow-up

Participants are monitored for changes in parenting attitudes and strategies post-intervention

4-10 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PriCARE

Trial Overview The trial is testing PriCARE, a program aimed at improving parenting skills and empathy among foster parents dealing with children's disruptive behaviors and mental health issues.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

All participants who enroll in the study will be assigned to a PriCARE group program that will adhere to the approximately 9 hour PriCARE curriculum.The trainings are administered to groups of approximately 4-12 caregivers at a time and are led by 2 mental health providers trained in the PriCARE curriculum. The curriculum will be delivered in 2-6 sessions over a 2-20 week period.

PriCARE is already approved in United States for the following indications:

Approved in United States as PriCARE for:

• Promoting positive parenting
• Increasing empathy among foster caregivers
• Reducing risk of child maltreatment

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Ray E. Helfer Society

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

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]

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]

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]

A systematic review of 18 studies on universal parenting programs from 2015 to 2019 found that 89% of these programs led to improved parenting outcomes, highlighting their effectiveness in enhancing parental behavior and practices.

The review also indicated that these programs not only reduced child behavior problems in 8 out of 9 evaluated variables but also positively impacted parental mental health and relationships, suggesting a comprehensive benefit of parenting interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Universal Intervention to Strengthen Parenting and Prevent Child Maltreatment: Updated Systematic Review. Branco, MSS., Altafim, ERP., Linhares, MBM.[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 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 IntegratedCARE model, adapted from the Child-Adult Relationship Enhancement (CARE) interaction model, was successfully implemented in primary care settings, providing a brief 3-session treatment to 30 parent-child dyads.

Participants showed significant improvements in child behavior, as indicated by decreased scores on the Eyberg Childhood Behavior Inventory, and reported high satisfaction with the treatment, suggesting that IntegratedCARE is both effective and feasible for use by trained professionals in routine primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated CARE: Adaptation of Child-Adult Relationship Enhancement (CARE) Model for Use in Integrated Behavioral Pediatric Care. Scott, B., Gurwitch, RH., Messer, EP., et al.[2021]

Citations

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

Child Adult Relationship Enhancement in Primary Care ... PriCARE has the potential to reduce risk of CM directly through improving parenting behaviors and indirectly through the impact of those changes in parenting ...

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

A promising intervention to reduce child maltreatment PriCARE has the potential to reduce risk of CM directly through improving parenting behaviors and indirectly through the impact of those changes in parenting ...

3. 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.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38448354/

A promising intervention to reduce child maltreatment - PubMed PriCARE has the potential to reduce risk of CM directly through improving parenting behaviors and indirectly through the impact of those changes in parenting ...

7. policylab.chop.edu policylab.chop.edu/article/child-adult-relationship-enhancement-primary-care-pricare-study-designprotocol-randomized

Child Adult Relationship Enhancement in Primary Care ... This study is a multicenter randomized controlled trial with two parallel arms. Children, 2-6 years old with Medicaid/CHIP/no insurance, and their English- and ...