Home-based intervention for infants with behavior problems
The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project
This study is testing a remote program to see if it can help reduce behavior problems in infants from high-risk families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 12 Months to 18 Months |
| Sex | All |
| Sponsor | Florida International University Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT04594902 on ClinicalTrials.gov |
What this trial studies
The PANTHERS Project evaluates the effectiveness of a remote home-based intervention called the Infant Behavior Program (IBP) aimed at reducing behavior problems in infants from high-risk families. Families will participate in five remote evaluations and receive six remote treatment sessions of either the IBP or an enhanced pediatric primary care (EPPC) program. The study employs a randomized controlled trial design, with assessments conducted before and after the intervention, as well as at multiple follow-up points over the course of a year.
Who should consider this trial
Good fit: Ideal candidates include infants aged 12 to 18 months with elevated behavior problem scores and their primary caregivers, who must be English or Spanish speakers.
Not a fit: Patients with major sensory impairments, significant cognitive delays in caregivers, or those involved with child protection services may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide families with effective strategies to manage and reduce behavior problems in their infants.
How similar studies have performed: Other studies have shown success with similar remote intervention approaches, indicating potential for positive outcomes in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants ages 12 to 18 months and at least one primary caretaker, who is at least 18-years-old and in most cases will be the mother * Elevated score (\> 75th percentile) on the problem scale of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan et al., 2004) * An English-speaking or Spanish-speaking primary caregiver. Exclusion Criteria: * Infants with major sensory impairment (e.g., deafness blindness) or several problems that impair mobility (e.g., cerebral palsy) * 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
Where this trial is running
Miami, Florida and 1 other locations
- South Miami Children's Clinic — Miami, Florida, United States (Recruiting)
- Nicklaus Children's Hospital — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Daniel M Bagner, PhD — Florida International University
- Study coordinator: Daniel M Bagner, PhD
- Email: dbagner@fiu.edu
- Phone: 305-348-7548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.