A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Apr 19, 2021
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a program called Play and Learning Strategies (PALS) to see if it can help parents be more responsive to their toddlers who were born prematurely. The goal is to find out if this program can improve the way toddlers learn and develop their brains. Researchers are looking for families with toddlers aged 15 months to 2 years who were born preterm. To join the study, mothers need to be over 18 years old and meet certain health criteria, meaning they should not have serious health issues like specific congenital anomalies or infections.
Participants in the trial will take part in the PALS program, which includes fun and educational activities designed to enhance their interactions with their child. Families will be closely supported throughout the study, and researchers will also check how the toddlers' skills and brain development improve over time. This is an exciting opportunity for families who want to support their child's growth and learn more about effective parenting strategies for toddlers born preterm.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • - Maternal age over 18-years when child was born
- Exclusion Criteria:
- • 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
About The University Of Texas Health Science Center, Houston
The University of Texas Health Science Center at Houston (UTHealth) is a leading academic institution dedicated to advancing health through education, research, and clinical practice. As a prominent sponsor of clinical trials, UTHealth leverages its extensive resources and expertise in biomedical research to facilitate innovative studies aimed at improving patient outcomes. The institution is committed to fostering a collaborative environment that promotes scientific discovery and the translation of research findings into effective healthcare solutions, all while adhering to the highest ethical standards and regulatory guidelines. With a multidisciplinary approach, UTHealth plays a critical role in addressing complex health challenges and enhancing the quality of life in diverse communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Patients applied
Trial Officials
Dana DeMaster, PhD
Principal Investigator
The University of Texas Health Science Center, Houston
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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