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ACTIVE NOT RECRUITING
NCT04594902
NA

The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project

Sponsor: Florida International University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

12 Months - 18 Months

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2021-03-08

Completion Date

2026-09-07

Last Updated

2025-12-02

Healthy Volunteers

Yes

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.

Locations (2)

South Miami Children's Clinic

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States