Actively Recruiting
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Led by The University of Texas Health Science Center, Houston · Updated on 2025-03-28
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
H
Herman H. Fleishman Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 participation in PALS results in increases in toddler skills and/or toddler neurological development.
CONDITIONS
Brief Title
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age over 18-years when child was born
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Dana DeMaster, PhD
K
Kelly Vaughn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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