Responsive parenting intervention for toddlers born preterm
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
This study is testing if a special program can help parents be more responsive to their toddlers who were born early, to see if it improves the children's development and brain growth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 15 Months to 30 Months |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04856501 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the Play and Learning Strategies (PALS) intervention in enhancing caregiver responsiveness and promoting healthy brain development in toddlers who were born prematurely. Participants will be randomly assigned to either the PALS intervention group or a control group to assess changes in toddler skills and neurological development. The study will involve monitoring caregiver behaviors and toddler outcomes over a specified period. The goal is to determine if increased caregiver engagement can positively influence developmental trajectories in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are mothers over 18 years old with toddlers who were born preterm and do not have significant medical complications.
Not a fit: Patients who have congenital anomalies, severe neurological impairments, or reside outside the designated catchment area may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved developmental outcomes for toddlers born preterm, enhancing their cognitive and emotional skills.
How similar studies have performed: Other studies have shown promise in using responsive parenting interventions to support child development, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dana DeMaster, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Dana DeMaster, PhD
- Email: Dana.M.DeMaster@uth.tmc.edu
- Phone: (713) 500-8315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.