Home-Based Infant Behavior Intervention for Behavioral Problems

(PANTHERS Trial)

Not currently recruiting at 1 trial location

Overseen By Daniella Vaclavik, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Sensory impairment, Cognitive delay, Child protection, others

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

Compensation: Varies

Number of Visits: 30

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a remote home-based program in reducing behavior problems in infants from high-risk families. Participants will receive either the Infant Behavior Program (IBP), which enhances parent-infant interaction, or Enhanced Pediatric Primary Care (EPPC), which educates on key developmental and health topics. Both treatments are delivered through remote sessions. Families with infants aged 12 to 18 months who exhibit noticeable behavior issues and have an English or Spanish-speaking caregiver may be suitable for this trial. As an unphased trial, this study offers families the chance to contribute to innovative research that could improve early childhood development strategies.

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

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Infant Behavior Program (IBP) is safe and well-received. This program, a home-based version of Parent-Child Interaction Therapy (PCIT), effectively addresses children's behavior issues. Importantly, no major reports of negative effects have emerged from this treatment. Thus, the IBP is safe for families seeking to address early behavior problems in infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Infant Behavior Program (IBP) because it offers a novel home-based approach specifically tailored for infants, addressing their unique developmental needs. Unlike traditional methods that often require in-person sessions, IBP can be completed entirely remotely, making it more accessible for families. This approach adapts the evidence-based Child-Directed Interaction phase of Parent-Child Interaction Therapy, which is already known for effectively managing early behavioral problems. By maintaining the core features of this proven therapy and adapting it for infants, IBP holds promise for early intervention in a convenient, family-centered manner.

What evidence suggests that this trial's treatments could be effective for decreasing behavior problems in infants?

Research has shown that the Infant Behavior Program (IBP), a treatment in this trial, can help reduce behavior problems in babies. Specifically, studies found that babies participating in the IBP demonstrated better self-control after the program. At a 6-month follow-up, these babies also listened to their parents more and had fewer outbursts, such as tantrums. The program shows promise for improving behaviors in both babies and parents. The IBP is based on Parent-Child Interaction Therapy but is specially adjusted for babies' needs. ^{2 6 7 8 9}

Who Is on the Research Team?

Daniel M Bagner, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

The PANTHERS Project is for infants aged 12 to 18 months with behavior problems and their primary caretakers, who must be at least 18 years old. Caretakers should speak English or Spanish and have no significant cognitive delays. Families involved with child protection services or infants with major sensory impairments or severe mobility issues cannot participate.

Inclusion Criteria

Elevated score (> 75th percentile) on the problem scale of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan et al., 2004)

I am a primary caretaker of an infant aged 12-18 months.

Exclusion Criteria

Significant cognitive delay in the primary caregiver (i.e., estimated IQ score < 70 on the vocabulary subtest of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) for those speaking English or an average standard score < 4 on the vocabulary subtest of the Escala de Inteligencia Wechsler Para Adultos - Third Edition (EIWA-III) for those speaking Spanish)

Families involved with child protection services, which is expected to be low based on our pilot trials

My child has a major sensory impairment or mobility issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six remote treatment sessions of either the Infant Behavior Program (IBP) or the Enhanced Pediatric Primary Care (EPPC) program

8 weeks

6 remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Remote assessments at weeks 24, 40, and 56

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Pediatric Primary Care (EPPC)
• Infant Behavior Program (IBP)

Trial Overview

This study tests a remote home-based program called the Infant Behavior Program (IBP) against Enhanced Pediatric Primary Care (EPPC). It aims to reduce behavioral issues in high-risk families' infants through six treatment sessions, all conducted remotely.

How Is the Trial Designed?

Group I: Infant Behavior Program (IBP) Experimental Treatment 1 Intervention

Infant Behavior Program (IBP) is a home-based adaptation of the Child-Directed Interaction (CDI) phase of Parent-Child Interaction Therapy (PCIT), an evidence-based intervention for early externalizing problems. Consistent with recommendations we maintained core features of CDI and addressed the unique developmental needs of infants. All IBP sessions will completed remotely.

Group II: Enhanced Pediatric Primary Care (EPPC) Active Control 1 Intervention

Families in EPPC will receive six one-hour home visits where they will receive information about normative developmental and health expectations for their infant. Specifically, therapists will provide education on six topics: (1) cognitive and emotional development; (2) language and social development; (3) safety; (4) feeding and nutrition; (5) sleep; and (6) fitness and activity. All EPPC sessions will completed remotely.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Collaborator

Trials

25

Recruited

873,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The Triple P Online Brief program significantly improved parenting strategies and increased parents' confidence in managing their children's disruptive behaviors, with these benefits lasting up to 9 months after the program.

While parents reported fewer child behavior problems at follow-up, these changes were not evident immediately after the program, indicating a delayed effect, and overall improvements in observed behaviors were not significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating a low-intensity interactive online parenting intervention, Triple P Online Brief, with parents of children with early onset conduct problems. Baker, S., Sanders, MR., Turner, KMT., et al.[2018]

The study aims to evaluate the feasibility of using smartwatches to monitor and assess emotional behavior problems (EBP) in children aged 3-7 years, involving 100 participants with clinically significant EBP as measured by the Eyberg Child Behavior Inventory.

The research will compare the effectiveness of an artificial intelligence-enhanced Parent-Child Interaction Therapy (AI-PCIT) against a sham treatment, with the goal of determining if real-time data collection can lead to better individualized treatment plans for managing EBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PISTACHIo (PreemptIon of diSrupTive behAvior in CHIldren): real-time monitoring of sleep and behavior of children 3-7 years old receiving parent-child interaction therapy augment with artificial intelligence - the study protocol, pilot study. Saliba, M., Drapeau, N., Skime, M., et al.[2023]

Developmental and behavioral services can be effectively integrated into primary care practices, leading to improved parental and provider satisfaction, as well as better parenting practices and health outcomes.

The 'planned care model' facilitated the implementation of these services, making it easier for healthcare providers to deliver care, which supports the case for broader adoption of such programs in child healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding developmental and behavioral services for newborns in primary care: implications of the findings. Thompson, RS., Lawrence, DM., Huebner, CE., et al.[2019]

The Integrated Behavioral Health (IBH) approach developed at Cincinnati Children's Hospital successfully transformed pediatric primary care (PPC) by fully integrating behavioral health services over a 4-year period, expanding to two additional clinics.

Key elements of the IBH program include a clear mission, universal prevention services, continuous quality improvement, and a focus on transforming both practice and healthcare systems, highlighting the need for robust models in pediatric behavioral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four innovations: A robust integrated behavioral health program in pediatric primary care. Herbst, RB., McClure, JM., Ammerman, RT., et al.[2021]

The study successfully developed a standardized Integrated Behavioral Health Prevention (IBH-P) model for pediatric primary care, demonstrating that it is feasible to implement in diverse settings with high fidelity.

Both provider self-ratings and independent ratings showed a high level of agreement (87.5%), indicating that the model can be reliably followed, which is crucial for ensuring high-quality, evidence-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learnings from the implementation of standardized content and processes for integrated behavioral health prevention visits. Meister, K., Ryan, P., Austin, J., et al.[2023]

Integrating behavioral parent training (BPT) into pediatric primary care settings is a promising approach to increase access for families, especially in low-income, predominantly Black communities.

The adaptations made to the BPT program were found to be feasible and acceptable, successfully engaging families and transforming the practices of primary care providers, which can help reduce behavioral health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a preschool disruptive behavior group for the underserved in pediatric primary care practice. Raglin Bignall, WJ., Herbst, RB., McClure, JM., et al.[2023]

The BASC questionnaire effectively identifies psychological and behavioral issues in premature infants, with significant findings showing high rates of inactivity, anxiety, and internalization problems among preterm children compared to full-term controls.

The study, involving 87 premature children and 43 full-term controls aged 5-7 years, revealed that preterm boys exhibited more hyperactivity and behavioral problems, while girls showed more attentional issues, highlighting the need for tailored assessments in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Identification of behavioural and emotional problems in premature children in the primary care setting]. Alcántara-Canabal, L., Fernández-Baizán, C., Solís-Sánchez, G., et al.[2021]

Integrated behavioral health (IBH) in primary care is effective in identifying and treating mental health issues in adolescents and young adults, showing better treatment outcomes compared to traditional primary care referrals.

To enhance the effectiveness and adoption of IBH, there is a need for dedicated training for healthcare providers and improved reimbursement models for IBH services, which could lead to better identification and treatment of behavioral health conditions in youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Integration of Behavioral Health Into Primary Care for Adolescents and Young Adults. [2021]

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