Status:
COMPLETED
Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program
Lead Sponsor:
Florida International University
Collaborating Sponsors:
University of Miami
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Conditions:
Developmental Delay
Disruptive Behavior
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
The Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program is a study funded by the National Institutes of Health to explore behavior and developmental problems amo...
Detailed Description
The proposed study will evaluate, via a randomized controlled trial, the incremental utility of I-PCIT for disruptive behavioral problems in traditionally underserved young children with developmental...
Eligibility Criteria
Inclusion
- Young children aging out of Part C EI services (mean age = 34.50 months) and at least 1 primary caretaker, which in most cases will be the mother
- Elevated Child Behavior Checklist Externalizing Problems scale at least in the borderline clinical range (i.e., T-score = 60)
- English-speaking or Spanish-speaking primary caretaker and child.
Exclusion
- Child receiving an unstable dose of medication (i.e., changes within the past 4 weeks) to manage behavior difficulties
- History of severe physical impairment (e.g., deafness, blindness) in the child or primary caretaker
- Severe autism spectrum disorder impairment (i.e., Social Responsiveness Scale, Second Edition \> 75)
- Significant cognitive delay in the parent (i.e., estimated IQ score \< 70 on the two-subtest \[vocabulary and matrix reasoning\] version of the Wechsler Abbreviated Scale of Intelligence for those speaking English or an average standard score \< 4 on the vocabulary and matrix reasoning subtests of the Escala de Inteligencia Wechsler Para Adultos - Third Edition for those speaking Spanish)
Key Trial Info
Start Date :
March 16 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03260816
Start Date
March 16 2016
End Date
December 21 2020
Last Update
June 3 2022
Active Locations (3)
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1
University of Miami, Early Steps North
Miami, Florida, United States, 33136
2
Florida International University
Miami, Florida, United States, 33199
3
Nicklaus Children's Hospital, Early Steps South
Palmetto Bay, Florida, United States, 33157