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

Purpose

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.

Condition

  • Premature Birth

Eligibility

Eligible Ages
Between 15 Months and 30 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PALS intervention condition
  • Behavioral: PALS intervention condition
    The Play and Learning Strategies (PALS) intervention provides parents with behaviors that, collectively, are known as a responsive parenting style. Four constructs make up this responsive parenting style: 1) contingent responsiveness, (responses are conditionally linked to the child's signals) 2) warm sensitivity (high levels of affection and understanding of child states), 3) maintaining vs. redirecting attention, and 4) verbal scaffolding (providing child appropriate language supports). Parents assigned to this intervention will be paired with a coach who will guide them through the program over the course of 9 weekly sessions. The intervention (ePALS) will be implemented via an internet adaptation through the Children's Learning Institute's ENGAGE platform. However, ePALS could easily be adapted for other platforms and accessed with any web-enabled device.
Active Comparator
Control condition
  • Behavioral: Control condition
    Families assigned to the control condition will be provided with a website with information corresponding to milestones of toddler development. Control families will be asked to review that week's materials before the each of the 9 weekly coach calls. The active control condition serves three important purposes: 1) Maintains an active line of communication and accurate contact records for Post-test 1 and Post-test 2 session scheduling; 2) Masks participant's awareness of intervention vs. control assignment; and 3) Approximates communication with intervention staff such that results showing ePALS effects are attributable to intervention rather than regular communication with an interventionist.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Dana DeMaster, PhD
713-500-8315
Dana.M.DeMaster@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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