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NCT04856501 · ClinicalTrials.gov registry record · NA
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
A NA study of Premature Birth, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT04856501: Recruiting NA study of Premature Birth, sponsored by The University of Texas Health Science Center, Houston.
NCT04856501 is a NA study of Premature Birth that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 300 participants, below the 386-participant average among 38 other Premature Birth trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04856501, a NA study of Premature Birth, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (
Conditions Studied
Interventions
- BEHAVIORAL Control condition
- BEHAVIORAL PALS intervention condition
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
What NCT04856501 shows while recruiting
NCT04856501 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 386-participant average among 38 other Premature Birth trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Premature Birth appearing as the primary indexed condition, and to 2 interventions - of which Control condition is the first listed.
NCT04856501 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04856501 about?
NCT04856501 is a clinical study titled "A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm". 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 developmen...
What is the current status of trial NCT04856501?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2020-08-07. Estimated completion is 2025-06-30.
What conditions does trial NCT04856501 study?
This clinical trial studies the following conditions: Premature Birth.
What interventions are being tested in trial NCT04856501?
The interventions under investigation include: Control condition (BEHAVIORAL), PALS intervention condition (BEHAVIORAL).
Who is sponsoring clinical trial NCT04856501?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04856501 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Premature Birth
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04856501's enrollment target sits among peer trials
300 9th of 38 higher than 30 of 38 other Premature Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Premature Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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