300 Participants Needed

Responsive Parenting Intervention for Premature Birth

DD
KV
Overseen ByKelly Vaughn
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Responsive Parenting Intervention for Premature Birth treatment?

Research shows that early education programs like the Infant Health and Development Program can improve parenting skills and child development in high-risk children. Additionally, interventions such as CareToy and COPE have been effective in reducing parental stress and improving cognitive development in premature infants, suggesting that similar parenting interventions may be beneficial.12345

Is the Responsive Parenting Intervention for Premature Birth safe for humans?

The Responsive Parenting Intervention, including the Play and Learning Strategies (PALS) program, has been studied in various forms and has shown positive effects on parenting behaviors and child development without reported safety concerns. These interventions are designed to support parent-infant interactions and have been associated with reduced parental stress, particularly in mothers, suggesting they are safe and beneficial for families.14678

How is the PALS intervention treatment for premature birth different from other treatments?

The PALS intervention is unique because it focuses on responsive parenting, helping parents adapt to their child's changing needs through play and learning strategies. It is delivered in two phases, during infancy and toddler-preschool years, to enhance maternal warmth and cognitive responsiveness, which is not typically the focus of other treatments for premature birth.12369

What is the purpose of this trial?

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.

Research Team

DD

Dana DeMaster, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Exclusion Criteria

I have used drugs during my current pregnancy.
I have severe bleeding or fluid buildup in my brain.
I have a known or suspected genetic or heart birth defect.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Play and Learning Strategies (PALS) parenting intervention to improve caregiver responsiveness and toddler development

1-2 weeks
1 visit (in-person)

Post-test 1

Assessment of changes in parental and child behaviors using various tasks and observations

1-2 weeks after intervention
1 visit (in-person)

Post-test 2

Further assessment of child development and parental behaviors using advanced imaging and observational tasks

4 months after post-test 1
1 visit (in-person)

Follow-up

Participants are monitored for long-term effects of the intervention on child development and parental behaviors

4 months

Treatment Details

Interventions

  • Control condition
  • PALS intervention condition
Trial Overview 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: PALS intervention conditionExperimental Treatment1 Intervention
Group II: Control conditionActive Control1 Intervention

PALS intervention condition is already approved in United States for the following indications:

🇺🇸
Approved in United States as PALS for:
  • Supporting healthy brain development and self-regulation in toddlers born preterm
  • Enhancing caregiver responsiveness behaviors

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Herman H. Fleishman Foundation

Collaborator

Trials
1
Recruited
300+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Findings from Research

The Infant Health and Development Program, evaluated in a randomized clinical trial with 461 participants, showed that mothers in the treatment group provided significantly more enriching experiences for their children by age 18 compared to the control group.
Sustained improvements in parenting practices indicate that two-generation early education programs can effectively enhance parenting competence and support the long-term development of high-risk children.
Impact of a two-generation early education program on parenting processes at age 18.Bradley, RH., Whiteside-Mansell, L., Casey, PH., et al.[2014]
An additional parenting intervention for very preterm born toddlers, consisting of 4-6 home visits, was found to be feasible and well-received by parents, with high satisfaction reported.
The intervention showed positive outcomes, particularly in areas like motor development and parent-child interaction, with effect sizes ranging from small to large across various developmental measures at 24 months corrected age.
Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial.Flierman, M., Koldewijn, K., Meijssen, D., et al.[2018]
The Parent Baby Interaction Programme (PBIP), aimed at improving maternal responsiveness and infant development after very premature birth, showed no significant effects on infant neurobehavioural outcomes or mother-child interactions in a study involving 233 infants across six neonatal intensive care units.
Despite the intervention, both the PBIP and control groups had similar scores in caregiver assessments and parenting stress levels at three months, indicating that the program did not lead to measurable improvements in the targeted areas.
Randomised trial of a parenting intervention during neonatal intensive care.Glazebrook, C., Marlow, N., Israel, C., et al.[2022]

References

Impact of a two-generation early education program on parenting processes at age 18. [2014]
Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial. [2018]
Randomised trial of a parenting intervention during neonatal intensive care. [2022]
Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. [2020]
Improving cognitive development of low-birth-weight premature infants with the COPE program: a pilot study of the benefit of early NICU intervention with mothers. [2022]
A responsive parenting intervention: the optimal timing across early childhood for impacting maternal behaviors and child outcomes. [2022]
An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. [2021]
Randomized control trial of an internet-based parenting intervention for mothers of infants. [2021]
Parenting Style Interventions in Parents of Preterm and High-Risk Infants: Controversies, Cost, and Future Directions. [2023]
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