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A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm

Who can join

15 Months – 30 Months · All sexes

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 study

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.

What is being tested

• PALS intervention condition (behavioral)
• Control condition (behavioral)

Sponsor: The University of Texas Health Science Center, Houston · Participants: 300 · Started: Aug 7, 2020

Contact the study team

• Dana DeMaster, PhD · Phone: (713) 500-8315
• Kelly Vaughn · Phone: 713-500-8243

Official record on ClinicalTrials.gov — NCT04856501

Locations in the U.S.

Conditions

• Premature Birth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.