Infant Behavior Program (IBP) for Early Childhood Development

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Early Childhood Development+1 MoreInfant Behavior Program (IBP) - Behavioral
Eligibility
12 - 18
All Sexes
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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

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

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: Behavioral
Enhanced Pediatric Primary Care (EPPC)
Other
ActiveComparator Group · 1 Intervention: Enhanced Pediatric Primary Care (EPPC) · Intervention Types: Other

Trial 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