Status:
RECRUITING
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Herman H. Fleishman Foundation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Premature Birth
Eligibility:
All Genders
15-30 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if...
Eligibility Criteria
Inclusion
- \- Maternal age over 18-years when child was born
Exclusion
- presence of known/suspected congenital anomalies including chromosomal or complex congenital heart disease
- congenital infection including TORCH (Toxoplasmosis, Rubella, Cytomegalovirus, Herpes Simplex and others),untreated maternal HIV, or maternal syphilis
- bilateral grade 3/4 intraventricular hemorrhage,intraparenchymal hemorrhage, hydrocephalus
- Cerebral palsy with Gross Motor Function Classification of III or higher
- blindness-
- deafness
- Current maternal drug use or maternal drug use during pregnancy
- families who reside outside the catchment area (\>1 hour drive from the Texas Medical Center)
- Child with contraindication for MRI. If the mother of the child is pregnant, thinks she might be pregnant, or has a contraindication for MRI, another relative of the child will be asked to assist with the MRIs
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04856501
Start Date
August 7 2020
End Date
June 30 2025
Last Update
March 28 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030