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Home-Based Infant Behavior Intervention for Behavioral Problems (PANTHERS Trial)

N/A
Recruiting
Led By Daniel M Bagner, PhD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screen
Awards & highlights

PANTHERS Trial Summary

This trial will evaluate a remote home-based intervention, the Infant Behavior Program (IBP), to see if it can decrease behavior problems in infants from high-risk families.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focused on behavior management and development support, traditional side effects associated with medications are not applicable. However, there may be indirect effects related to changes in family dynamics or stress.

PANTHERS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~repeated at weeks 8, 24, 40, and 56.
This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated at weeks 8, 24, 40, and 56. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Infant-Toddler Social and Emotional Assessment (ITSEA)
Secondary outcome measures
Abbreviated Multidimensional Acculturation Scale (AMAS)
Adult Executive Functioning Inventory (ADEXI)
Ages and Stages Questionnaire-Third Edition (ASQ-III)
+23 more

PANTHERS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Infant Behavior Program (IBP)Experimental Treatment1 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 Control1 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.

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Who is running the clinical trial?

Florida International UniversityLead Sponsor
99 Previous Clinical Trials
17,019 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,671,932 Total Patients Enrolled
Nicklaus Children's Hospital f/k/a Miami Children's HospitalOTHER
24 Previous Clinical Trials
872,685 Total Patients Enrolled

Media Library

Enhanced Pediatric Primary Care (EPPC) Clinical Trial Eligibility Overview. Trial Name: NCT04594902 — N/A
Early Childhood Development Research Study Groups: Infant Behavior Program (IBP), Enhanced Pediatric Primary Care (EPPC)
Early Childhood Development Clinical Trial 2023: Enhanced Pediatric Primary Care (EPPC) Highlights & Side Effects. Trial Name: NCT04594902 — N/A
Enhanced Pediatric Primary Care (EPPC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594902 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team actively seeking participants?

"Affirmative. The clinicaltrials.gov database confirms that this trial, which began accepting applications on March 8th 2021, is presently open for recruitment. This medical investigation requires a total of 288 participants to be enrolled at two separate sites."

Answered by AI

Does this research endeavor welcome those who are under the age of 65?

"To be eligible for this study, participants must fall between 12 months and 18 months old. There are 58 trials available for minors and 60 studies designated for adults aged 65 or above."

Answered by AI

How extensive is the cohort participating in this experiment?

"Affirmative. Clinicaltrials.gov data reveals that recruitment for this medical experiment, which was initiated on 8th March 2021, is currently ongoing. The trial requires 288 participants from 2 sites to be enrolled."

Answered by AI

Who qualifies for participation in this investigation?

"This medical trial is seeking 288 participants with early childhood development within the range of 12 to 18 months. Those who meet this criteria have a chance of being accepted into the study."

Answered by AI
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~72 spots leftby Mar 2025