Study Summary
This trial will evaluate a remote home-based intervention, the Infant Behavior Program (IBP), to see if it can decrease behavior problems in infants from high-risk families.
Eligible Conditions
- Early Childhood Development
- Behavioral Problem
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 26 Secondary · Reporting Duration: Repeated at weeks 8, 24, 40, and 56.
Week 8
Infant-Toddler Social and Emotional Assessment (ITSEA)
Week 8
Brief Infant Sleep Questionnaire (BISQ)
COPING WITH TODDLERS' NEGATIVE EMOTION SCALE (CTNES)
Center for Epidemiologic Studies Depression Scale (CES-D)
Dyadic Parent-Child Interaction Coding System-IV (DPICS-4)
Early Childhood Behavior Questionnaire-Very Short Form (ECBQ)
Laboratory Temperament Assessment Battery (Lab-TAB)
Parental Sensitivity/Responsivity: Global codes from the Early Parenting Coding System (EPCS)
Parenting Scale
Positive and Negative Affective Schedule (PANAS)
Services for Children and Adolescents-Parent Interview (SCAPI)
Short-form version of the MacArthur Communicative Development Inventories
The Parenting Stress Index, Fourth Edition Short Form (PSI-SF)
Week 0
Screen Media Use Interview
Week 8
Screen Media Use Questionnaire B
Screen
Brief Infant-Toddler Social Emotional Assessment (BITSEA)
Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II)
Week 0
Abbreviated Multidimensional Acculturation Scale (AMAS)
Adult Executive Functioning Inventory (ADEXI)
Ages and Stages Questionnaire-Third Edition (ASQ-III)
Multidimensional Acculturative Stress Inventory (MASI)
NIH Cognitive Toolbox List Sorting Working Memory Test
Screen Media Use Questionnaire A
Technological Ease and Computer-based Habits Inventory (TECHI)
Week 8
EPPC Quiz
IBP Quiz
Therapy Attitude Inventory (TAI)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Enhanced Pediatric Primary Care (EPPC)
1 of 2
Infant Behavior Program (IBP)
1 of 2
Active Control
Experimental Treatment
288 Total Participants · 2 Treatment Groups
Primary Treatment: Infant Behavior Program (IBP) · No Placebo Group · N/A
Infant Behavior Program (IBP)
Behavioral
Experimental Group · 1 Intervention: Infant Behavior Program (IBP) · Intervention Types: BehavioralEnhanced Pediatric Primary Care (EPPC)
Other
ActiveComparator Group · 1 Intervention: Enhanced Pediatric Primary Care (EPPC) · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: repeated at weeks 8, 24, 40, and 56.
Who is running the clinical trial?
Nicklaus Children's Hospital f/k/a Miami Children's HospitalOTHER
23 Previous Clinical Trials
1,208,523 Total Patients Enrolled
Florida International UniversityLead Sponsor
85 Previous Clinical Trials
15,236 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,249,850 Total Patients Enrolled
Daniel M Bagner, PhDPrincipal InvestigatorFlorida International University
Eligibility Criteria
Age 12 - 18 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be able to communicate in English or Spanish.
You have at least one primary caretaker who is at least 18-years-old and in most cases will be the mother.
References
- Heymann, Perrine, Brynna H. Heflin, Melissa Baralt, and Daniel M. Bagner. 2020. “Infant-directed Language Following a Brief Behavioral Parenting Intervention: The Importance of Language Quality”. Infant Behavior and Development. Elsevier BV. doi:10.1016/j.infbeh.2019.101419.
- Morningstar, Michele, Dainelys Garcia, Melanie A. Dirks, and Daniel M. Bagner. 2019. “Changes in Parental Prosody Mediate Effect of Parent-training Intervention on Infant Language Production.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/ccp0000375.
- Blizzard, Angela M., Nicole E. Barroso, Francisco G. Ramos, Paulo A. Graziano, and Daniel M. Bagner. 2017. “Behavioral Parent Training in Infancy: What About the Parent–infant Relationship?”. Journal of Clinical Child & Adolescent Psychology. Informa UK Limited. doi:10.1080/15374416.2017.1310045.
- Ramos, Giovanni, Angela M. Blizzard, Nicole E. Barroso, and Daniel M. Bagner. 2017. “Parent Training and Skill Acquisition and Utilization Among Spanish- and English-speaking Latino Families”. Journal of Child and Family Studies. Springer Science and Business Media LLC. doi:10.1007/s10826-017-0881-7.
- Bagner, Daniel M., Stefany Coxe, Gabriela M. Hungerford, Dainelys Garcia, Nicole E. Barroso, Jennifer Hernandez, and Jose Rosa-Olivares. 2015. “Behavioral Parent Training in Infancy: A Window of Opportunity for High-risk Families”. Journal of Abnormal Child Psychology. Springer Science and Business Media LLC. doi:10.1007/s10802-015-0089-5.
- Bagner, Daniel M., Dainelys Garcia, and Ryan Hill. 2016. “Direct and Indirect Effects of Behavioral Parent Training on Infant Language Production”. Behavior Therapy. Elsevier BV. doi:10.1016/j.beth.2015.11.001.
- Bagner, Daniel M., Gabriela M. Rodríguez, Clair A. Blake, and Jose Rosa-Olivares. 2013. “Home-based Preventive Parenting Intervention for At-risk Infants and Their Families: An Open Trial”. Cognitive and Behavioral Practice. Elsevier BV. doi:10.1016/j.cbpra.2012.08.001.
- Garcia, Dainelys, Gabriela M. Rodriquez, Ryan M. Hill, Nicole E. Lorenzo, and Daniel M. Bagner. 2019. “Infant Language Production and Parenting Skills: A Randomized Controlled Trial”. Behavior Therapy. Elsevier BV. doi:10.1016/j.beth.2018.09.003.
- Bagner DM, Rodriguez GM, Blake CA, Rosa-Olivares J. Home-Based Preventive Parenting Intervention for at-Risk Infants and Their Families: An Open Trial. Cogn Behav Pract. 2013 Aug 1;20(3):334-348. doi: 10.1016/j.cbpra.2012.08.001.
- 2021. "The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04594902.
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Cancer Related
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