Responsive Parenting Intervention for Premature Birth
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Responsive Parenting Intervention for Premature Birth treatment?
Research shows that early education programs like the Infant Health and Development Program can improve parenting skills and child development in high-risk children. Additionally, interventions such as CareToy and COPE have been effective in reducing parental stress and improving cognitive development in premature infants, suggesting that similar parenting interventions may be beneficial.12345
Is the Responsive Parenting Intervention for Premature Birth safe for humans?
The Responsive Parenting Intervention, including the Play and Learning Strategies (PALS) program, has been studied in various forms and has shown positive effects on parenting behaviors and child development without reported safety concerns. These interventions are designed to support parent-infant interactions and have been associated with reduced parental stress, particularly in mothers, suggesting they are safe and beneficial for families.14678
How is the PALS intervention treatment for premature birth different from other treatments?
The PALS intervention is unique because it focuses on responsive parenting, helping parents adapt to their child's changing needs through play and learning strategies. It is delivered in two phases, during infancy and toddler-preschool years, to enhance maternal warmth and cognitive responsiveness, which is not typically the focus of other treatments for premature birth.12369
What is the purpose of this trial?
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.
Research Team
Dana DeMaster, PhD
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
This trial is for mothers over 18 with toddlers born preterm. It's not for those affected by certain infections (like TORCH), untreated HIV, or syphilis; drug use during pregnancy; living far from Texas Medical Center; or if the child has severe brain hemorrhage, hydrocephalus, advanced cerebral palsy, deafness, or significant congenital anomalies.Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants engage in the Play and Learning Strategies (PALS) parenting intervention to improve caregiver responsiveness and toddler development
Post-test 1
Assessment of changes in parental and child behaviors using various tasks and observations
Post-test 2
Further assessment of child development and parental behaviors using advanced imaging and observational tasks
Follow-up
Participants are monitored for long-term effects of the intervention on child development and parental behaviors
Treatment Details
Interventions
- Control condition
- PALS intervention condition
PALS intervention condition is already approved in United States for the following indications:
- Supporting healthy brain development and self-regulation in toddlers born preterm
- Enhancing caregiver responsiveness behaviors
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Herman H. Fleishman Foundation
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator