Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04594902
Study type Interventional
Source Florida International University
Contact Daniel M Bagner, PhD
Phone 305-348-7548
Email dbagner@fiu.edu
Status Recruiting
Phase N/A
Start date March 8, 2021
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT01955551 - Motivational Interviewing to Increase Parent Engagement in Preventive Parenting Programming Phase 2
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT00980512 - Community Implementation of KEEP: Fidelity and Generalization of Parenting N/A
Enrolling by invitation NCT00880126 - Community Development Teams to Scale-Up Multidimensional Treatment Foster Care (MTFC) in California Phase 2/Phase 3
Completed NCT01085305 - The Effectiveness of Parent-Child Interaction Therapy (PCIT) N/A
Completed NCT03153904 - Connecticut Child STEPs N/A
Recruiting NCT00571571 - Application and Evaluation of Transference Focused Psychotherapy Modified for Adolescents N/A
Recruiting NCT05591820 - A Randomized Controlled Trial on Brief Behavioral Parent Training N/A
Recruiting NCT05893550 - Omega-3 Supplementation to Both Parent and Adolescent Phase 3
Recruiting NCT00820859 - Treatment Routes for Exploring Agitation N/A
Completed NCT00133055 - Parenting Matters: Helping Parents With Young Children Phase 2
Completed NCT03112265 - Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes N/A
Completed NCT02877875 - Student Outcomes of Integrative Mental Health Services N/A
Terminated NCT01128777 - Teens Coping With Parental Military Deployment Phase 1
Completed NCT01441674 - Animal Assisted Therapy in a Pediatric Setting Phase 1/Phase 2
Recruiting NCT04505072 - RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes N/A
Completed NCT02800603 - A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems N/A
Completed NCT01261806 - Mental Health Services for Toddlers in Foster Care Phase 1