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

Description

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.

Conditions

Premature Birth

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Study Overview

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Study Details

Study 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.

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

Condition
Premature Birth
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

15 Months to 30 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Dana DeMaster, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2025-06-30