NCT04856501 A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
| NCT ID | NCT04856501 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Premature Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-08-07 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2020-08-07 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Dana DeMaster, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT04856501 clinical trial?
This trial is open to participants of all sexes, aged 15 Months or older, up to 30 Months, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04856501 currently recruiting?
Yes, NCT04856501 is actively recruiting participants. Contact the research team at Dana.M.DeMaster@uth.tmc.edu for enrollment information.
Where is the NCT04856501 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04856501 clinical trial?
NCT04856501 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Dana DeMaster, PhD at The University of Texas Health Science Center, Houston. The trial plans to enroll 300 participants.