A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm (NCT04856501)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: The University of Texas Health Science Center at Houston — Houston, Texas
Age range: 15 Months to 30 Months
🧪 Interventions in This Study
- PALS intervention condition (BEHAVIORAL)
- Control condition (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- The University of Texas Health Science Center at Houston — Houston, Texas
📞 Contact the Study Coordinator
Phone: (713) 500-8315
Email: Dana.M.DeMaster@uth.tmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.