Behavior Problems Clinical Trial
Official title:
The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project
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.
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. ;
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 |