NCT04594902

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Florida International University · Academic / Other
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

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.

Detailed description

Research Design: The proposed study will 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. Specifically, the investigators propose to conduct a randomized controlled trial to demonstrate its efficacy and maintenance in reducing behavior problems and increasing infant regulation relative to an enhanced pediatric primary care (EPPC) active control condition. Assessments will occur at pre (week 0)- and post (week 8)-intervention assessments (approximately 2 months apart), as well as at 4-month (week 24) , 8 -month (week 40), and 12-month (week 56) follow-up assessments. Procedures: Families will be primarily recruited from pediatric primary care centers and will be randomized to receive six sessions of either IBP or EPPC in their home. Families also will participate in five remote home-based assessments. Risks and Benefits: Families may experience risk from a breach in confidentiality as participants reveal sensitive information and there are risks in breach of confidentiality due to videoconferencing methods, in particular if study staff become aware of abuse or neglect situations. Families may experience discomfort when answering personal questions. Benefits to families could include providing families with information that can assist in caring for their child, and instilling new parenting strategies that are designed to outlast treatment. Knowledge: This study will provide information about the efficacy of a remote home-based preventive intervention to improve infant behavior and regulation.

Conditions

• Early Childhood Development
• Behavior Problems

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-08
• Primary completion: 2026-09-07
• Completion: 2026-09-07
• First posted: 2020-10-20
• Last updated: 2025-12-02

Locations

2 sites across 1 country: United States