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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

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

Recruiting
15-30 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Premature Birth

NCT04856501

The University of Texas Health Science Center, Houston

15 May 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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