PALS intervention condition for Premature Birth

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Premature Birth
PALS intervention condition - Behavioral
Eligibility
< 18
All Sexes
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Study Summary

This study is evaluating whether a parenting intervention may help improve the development of children.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PALS intervention condition will improve 41 primary outcomes and 4 secondary outcomes in patients with Premature Birth. Measurement will happen over the course of Post-test 1 (1-2 weeks post intervention).

Week 2
Change in Child attentional engagement (engagement with environment) as measured by the Parent-child Toy Play Observation
Change in Child attentional engagement (social engagement) as measured by the Parent-child Toy Play Observation
Change in Child cooperation as measured by the Parent-child Toy Play Observation
Change in Child emotional regulation (disengaged behavior) as assessed by score on Waiting Task
Change in Child emotional regulation (proximity seeking behaviors) as assessed by score on Waiting Task
Change in Child emotional regulation (venting/aggression/distress behaviors) as assessed by score on Waiting Task
Change in Child emotional regulation as measured by the Parent-child Toy Play Observation
Change in Child inhibition (self-distraction) as assessed by score on Waiting Task
Change in Child inhibition (verbal distraction) as assessed by score on Waiting Task
Change in Number of times parent exhibits non-responsive behavior(prevention behaviors) as measured by the Waiting Task
Change in Parental contingent responsiveness as measured by the Parent-child Toy Play Observation
Change in Parental maintaining of child's signals and interests as measured by the Parent-child Toy Play Observation
Change in Parental verbal scaffolding as measured by the Parent-child Toy Play Observation
Change in Parental warm sensitivity (display of positive affect) as measured by the Parent-child Toy Play Observation
Change in Parental warm sensitivity (warmth) as measured by the Parent-child Toy Play Observation
Change in number of times parent exhibit warm sensitivity (physical soothing behaviors) as measured by the Waiting Task
Change in number of times parent exhibits parental contingent responsiveness (responsive behavior - promotion behaviors) as measured by the Waiting Task
Change in number of times parent exhibits parental non-responsive behavior(destructive coping and harsh physical restraint behaviors) as measured by the Waiting Task
Change in number of times parent exhibits parental verbal scaffolding (verbal distraction behaviors) as measured by the Waiting Task
Month 4
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
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - anterior thalamic radiation tract
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - cingulum tract
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - fornix tract
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - uncinate fasciculus tract
Change in children's developing abilities in early language as assessed by the MacArthur-Bates Communicative Development Inventories (MB-CDIs)
Change in functional activity during rest as indicated by Resting Electroencephalography (EEG) value
Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) negative central (NC) value recorded during EEG
Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) positive slow wave (PSW) value recorded during EEG
Month 4
Change in Child enthusiasm for the task as measured by the Tool task
Change in Child persistence behaviors related to attention as measured by the Tool task
Change in Child working memory as assessed by the 3-6-9 box task
Change in Child's distraction as assessed by score in the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
Change in Child's self-restraint as assessed by score on the Gift Wrap step of the Gift Wrap/Waiting for Bow task
Change in Child's self-restraint as assessed by score on the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
Change in Childs problem solving skill as measured by the Independent Toy Play task
Change in Noncompliance behaviors of child toward parent as measured by the Tool task
Change in anger behaviors of child as measured by the Tool task
Change in anger/frustration behaviors specifically directed to parent as measured by the Tool task
Change in child coping as measured by the Tool task
Week 2
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
Maternal depression as measured by the Beck's Depression Inventory

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control condition
1 of 2
PALS intervention condition
1 of 2
Active Control
Experimental Treatment

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. PALS Intervention Condition is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PALS intervention condition
Behavioral
Control condition
Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post-test 1 (1-2 weeks after intervention)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, post-test 1 (1-2 weeks after intervention) for reporting.

Who is running the study

Principal Investigator
D. D.
Prof. Dana DeMaster, Assistant Professor
The University of Texas Health Science Center, Houston

Closest Location

The University of Texas Health Science Center at Houston - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
- Maternal age over 18-years when child was born

Patient Q&A Section

How many people get premature birth a year in the United States?

"Over one million preterm infants may be born a year in the USA. The impact of preterm birth on a population's health and welfare will require coordinated action by state and federal officials and by public and private organizations in the community." - Anonymous Online Contributor

Unverified Answer

What are the signs of premature birth?

"In premature birth, apgar scores <7 on admission show a high sensitivity (95.8%) and specificity (99.6%) to predict severe intraventricular hemorrhage, in the first hour. We recommend immediate delivery in any case of apgar score <7 when the first auscultation is performed. Severe neonatal seizures, with or without intracranial hemorrhage, have a 10% probability of presenting anytime within the first 1 hour after birth, and can be attributed to birth asphyxia. We recommend emergency delivery for newborn newborn with apgar scores <7, and immediate delivery for a lower apgar; we also advise prompt and immediate treatment in birth asphyxia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for premature birth?

"A Cochrane systematic review of interventions for premature birth showed high-quality evidence of an association between low birth weight SGA and prenatal use of folic acid, zinc, or antioxidant supplements. The authors did not draw any conclusions regarding the safety or efficacy of these supplements, highlighting that more research is required to determine the optimal timing, dosing, and effect of these supplements. Further research is required to assess the extent to which other treatments can reduce the risks associated with premature birth and their adverse effects." - Anonymous Online Contributor

Unverified Answer

What causes premature birth?

"A combination of factors can cause premature birth, including maternal conditions related to fetal growth (placental compromise, pre-eclampsia). A history of pre-eclampsia predicts a greater risk of having a premature birth, likely through more severe adverse pregnancy outcomes." - Anonymous Online Contributor

Unverified Answer

Can premature birth be cured?

"Premature birth may be prevented in some cases, but its cure remains doubtful. The main obstacle in such a case is the complexity and the risk of further pregnancy." - Anonymous Online Contributor

Unverified Answer

What is premature birth?

"Premature birth is the birth of a child before 39 weeks' gestation (when the pregnancy is still in the last trimester and the mother is pregnant with her second child) or a child born at less than 37 weeks' gestation (when the pregnancy is in its last few weeks and the baby's lungs and heart have completed their growth). Premature birth occurred in 1 in 5000 births as of 2010, up from 1 in 2500 births in 2000. Premature birth is most common in the United States, Europe, and the Americas. In the United States, the leading risk factors for preterm delivery are smoking during pregnancy, a long mother's age, and a mother's lack of education." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for premature birth?

"In general, there is evidence that individuals are more willing to participate in trials if they have knowledge of their condition prior to enrollment and knowledge that they are eligible for the trial. There is some evidence that individuals willing to participate are more likely to enroll in trials where possible adverse effects in pregnancy are included in the informed consent process." - Anonymous Online Contributor

Unverified Answer

What does pals intervention condition usually treat?

"Clinicians used a combination of interventions to help premature babies, including a variety of care, to improve long-term outcomes. The intervention and some of the characteristics that were associated with change indicated that the study has potential to inform clinical practice and future studies." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets premature birth?

"It is important that pregnant women get a complete general practitioner’s assessment, so they can receive the most appropriate care. There are several indications that need to be followed during pregnancy and after delivery. They are mainly: (a) check for breech birth, (b) check for multiple birth, and (c) check for low-birth-weight and preterm infants. This consultation should occur frequently, e.g. 6 times per year." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating premature birth?

"The studies have been quite thorough, but unfortunately, there has been little advancement in identifying possible drugs for premature infant treatment. Although many of the newborn infants currently being placed in hospital-based NICUs do have serious neonatal morbidities such as bronchopulmonary dysplasia and retinopathy of prematurity, there is still a growing body of evidence suggesting that earlier intervention during pregnancy may potentially allow these children to survive and flourish. It seems as if there is a possibility of using drugs that have already proven their effectiveness to treat premature babies for a long time, as long as the side effects can be controlled and monitored." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pals intervention condition?

"Results from a recent clinical trial of our pilot study suggested that our intervention might have the capacity to be beneficial and should be assessed in more recent trials." - Anonymous Online Contributor

Unverified Answer

Does premature birth run in families?

"A positive family history of premature birth is associated with a higher percentage of premature infants. Results from a recent paper, a family history of premature birth and neonatal death was associated with a significantly increased incidence of premature neonatal death in the subsequent children. Families should be advised to avoid any additional morbidity and mortality by avoiding any further pregnancies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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