The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project
NCT04594902 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288
Last updated 2025-12-02
Summary
The PANTHERS (Parents And iNfants Together in Home-based Early Remote Services) Projects is a study funded by the National Institute of Child Health and Human Development to evaluate the efficacy and maintenance of a remote home-based preventive intervention, the Infant Behavior Program (IBP), to decrease behavior problems in infants from high-risk families. All families will participate in five remote evaluations in their home, and families will also receive 6 remote treatment sessions of either the IBP or the EPPC. All participant procedures will be conducted remotely.
Conditions
- Early Childhood Development
- Behavior Problems
Interventions
- BEHAVIORAL
-
Infant Behavior Program (IBP)
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.
- OTHER
-
Enhanced Pediatric Primary Care (EPPC)
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.
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
collaborator OTHER -
Florida International University
lead OTHER
Principal Investigators
-
Daniel M Bagner, PhD · Florida International University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Months
- Max Age
- 18 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-03-08
- Primary Completion
- 2026-09-07
- Completion
- 2026-09-07
Countries
- United States
Study Locations
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