ACTIVE_NOT_RECRUITING

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

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Conditions

Early Childhood DevelopmentBehavior Problems

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-08
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04594902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 18 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants ages 12 to 18 months and at least one primary caretaker, who is at least 18-years-old and in most cases will be the mother
  2. * Elevated score (\> 75th percentile) on the problem scale of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan et al., 2004)
  3. * An English-speaking or Spanish-speaking primary caregiver.
  1. * Infants with major sensory impairment (e.g., deafness blindness) or several problems that impair mobility (e.g., cerebral palsy)
  2. * Significant cognitive delay in the primary caregiver (i.e., estimated IQ score \< 70 on the vocabulary subtest of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) for those speaking English or an average standard score \< 4 on the vocabulary subtest of the Escala de Inteligencia Wechsler Para Adultos - Third Edition (EIWA-III) for those speaking Spanish)
  3. * Families involved with child protection services, which is expected to be low based on our pilot trials

Contacts and Locations

Principal Investigator

Daniel M Bagner, PhD
PRINCIPAL_INVESTIGATOR
Florida International University

Study Locations (Sites)

South Miami Children's Clinic
Miami, Florida, 33143
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States

Collaborators and Investigators

Sponsor: Florida International University

  • Daniel M Bagner, PhD, PRINCIPAL_INVESTIGATOR, Florida International University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-08
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-03-08
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Early Childhood Development
  • Behavior Problems