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Behavioral Intervention
Responsive Parenting Intervention for Premature Birth
N/A
Recruiting
Led By Dana DeMaster, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-test 1 (1-2 weeks post intervention)
Awards & highlights
Study Summary
This trial will test if the Play and Learning Strategies parenting intervention increases caregiver responsiveness and toddler skills or neurological development.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests a parenting program called PALS to see if it helps caregivers respond better and improves toddler skills and brain development. Participants are randomly assigned to either the usual care group or the PALS intervention group.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention focusing on parenting strategies rather than medication or medical procedures, there are no direct physical side effects expected from participating in the PALS program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-test 1 (1-2 weeks post intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-test 1 (1-2 weeks post intervention)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Attention Disengagement to Positive and Negative Emotions as assessed by longest individual time child looked at faces on screen during the looking task
Change in Attention Disengagement to Positive and Negative Emotions as assessed by the number of times child looked away from the faces and toward the distractor during the looking task
Change in Attention Disengagement to Positive and Negative Emotions as assessed by total time child looked at faces on screen during the looking task
+38 moreSecondary outcome measures
COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Exposure Score
COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Impact Score
Degree of chaos in the home as measured by the CHAOS questionnaire
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PALS intervention conditionExperimental Treatment1 Intervention
Group II: Control conditionActive Control1 Intervention
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
913 Previous Clinical Trials
323,922 Total Patients Enrolled
12 Trials studying Premature Birth
6,057 Patients Enrolled for Premature Birth
Herman H. Fleishman FoundationUNKNOWN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,978 Previous Clinical Trials
2,680,053 Total Patients Enrolled
65 Trials studying Premature Birth
119,210 Patients Enrolled for Premature Birth
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used drugs during my current pregnancy.I have severe bleeding or fluid buildup in my brain.I was over 18 when my child was born.I have a known or suspected genetic or heart birth defect.My cerebral palsy affects my ability to move and walk significantly.I have not been diagnosed with infections like Toxoplasmosis, Rubella, CMV, Herpes, HIV, or Syphilis.You are unable to see.You have hearing loss or are deaf.
Research Study Groups:
This trial has the following groups:- Group 1: PALS intervention condition
- Group 2: Control condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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