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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

RecruitingNAAges 15 Months - 30 MonthsAllThe University of Texas Health Science Center, Ho…
NCT04856501 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • PALS intervention condition
  • Control condition
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Where

1 site
The University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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