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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 | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT04856501•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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

Age

1 - 2 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

August 7, 2020

Primary Completion Date

June 30, 2025

Completion Date

June 30, 2025

Last Updated

March 28, 2025

Enrollment

300

ESTIMATED participants

Conditions

Premature Birth

Interventions

PALS intervention condition

BEHAVIORAL

Control condition

BEHAVIORAL

Contacts

Dana DeMaster, PhD

CONTACT

(713) 500-8315 Dana.M.DeMaster@uth.tmc.edu

Kelly Vaughn

CONTACT

713-500-8243 Kelly.A.Vaughn@uth.tmc.edu

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Preterm PregnancyPremature Birth

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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