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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 baseline, post-test 1 (1-2 weeks after 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 ~ baseline, post-test 1 (1-2 weeks after intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-test 1 (1-2 weeks after intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-test 1 (1-2 weeks after intervention) for reporting.

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 more

Secondary 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 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PALS intervention conditionExperimental Treatment1 Intervention

Group II: Control conditionActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,660 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

1,965 Previous Clinical Trials

2,672,497 Total Patients Enrolled

65 Trials studying Premature Birth

119,210 Patients Enrolled for Premature Birth

Media Library

PALS intervention condition (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04856501 — N/A

Premature Birth Research Study Groups: PALS intervention condition, Control condition

Premature Birth Clinical Trial 2023: PALS intervention condition Highlights & Side Effects. Trial Name: NCT04856501 — N/A

PALS intervention condition (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04856501 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there certain criteria for participants to be accepted into this clinical trial?

"Eligibility for this research requires a history of premature birth within the 15 to 30 months age range. There is space for 300 participants in total."

Answered by AI

Are there still opportunities to join this investigation?

"Affirmative, the data on clinicaltrials.gov reveals that this experiment is presently seeking participants. It was published on 8/7/2020 and has been edited most recently on 9/3/2021. The researchers are in search of 300 patients for their single location undertaking."

Answered by AI

What impact is this trial intended to have on the medical field?

"This medical study aims to measure the Change in Parental verbal scaffolding as observed through Parent-child Toy Play Observations, with Baseline and Post-test 1 (1-2 weeks after intervention) being key assessment points. Secondary outcomes include Degree of chaos in the home, which is evaluated by a 15 item CHAOS questionnaire ranging from 15 - 90; higher scores indicating greater domestic chaos. Additionally, family exposure to COVID-19 and its associated impacts are assessed via the COVID Exposure & Family Impact Survey – comprising an Exposure Score range 0 - 25 that assesses potential trauma related elements of coronavirus contamination and an Impact"

Answered by AI

Is the eligibility for this medical study restricted to individuals over 20 years old?

"This medical study is specifically looking for infants aged 15 months to 30 months. Additionally, there are 184 studies available to those under 18 and 74 studies open to senior citizens above 65 years old."

Answered by AI

What is the aggregate size of the patient cohort participating in this clinical trial?

"Affirmative, clinicaltrials.gov data implies that the trial is currently enrolling participants. It was initially advertised on August 7th 2020 and has been updated as recently as September 3rd 2021. There are 300 positions open at one site of recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm

Dana DeMaster 2020. "A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04856501.