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

The University of Texas System (UT)

Status

Enrolling

Conditions

Premature Birth

Treatments

Behavioral: Control condition

Behavioral: PALS intervention condition

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04856501

1R01HD100560-01A1 (U.S. NIH Grant/Contract)

HSC-MS-17-0190

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

15 to 30 months old

Volunteers

No 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