Responsive parenting intervention for toddlers born preterm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of the Play and Learning Strategies (PALS) intervention in enhancing caregiver responsiveness and promoting healthy brain development in toddlers who were born prematurely. Participants will be randomly assigned to either the PALS intervention group or a control group to assess changes in toddler skills and neurological development. The study will involve monitoring caregiver behaviors and toddler outcomes over a specified period. The goal is to determine if increased caregiver engagement can positively influence developmental trajectories in this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Dana DeMaster, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Dana DeMaster, PhD
• Email: Dana.M.DeMaster@uth.tmc.edu
• Phone: (713) 500-8315

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.