Responsive Parenting Intervention for Premature Birth

Overseen By Kelly Vaughn

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Congenital anomalies, Cerebral palsy, Drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

300 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

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

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{2 3 6 7 9}

Who Is on the Research Team?

Dana DeMaster, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: PALS intervention condition Experimental Treatment 1 Intervention

Group II: Control condition Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of a parenting intervention during neonatal intensive care. Glazebrook, C., Marlow, N., Israel, C., et al.[2022]

The CareToy intervention, an individualized home-based program for preterm infants, significantly reduced parenting stress in mothers compared to Standard Care, as measured by the Parenting Stress Index-Short Form after 4 weeks.

While mothers showed a notable decrease in parental distress, fathers did not experience significant changes, highlighting the greater impact of the CareToy program on mothers who were more involved in the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. Sgandurra, G., Beani, E., Inguaggiato, E., et al.[2020]

The COPE intervention program significantly improved cognitive development in low-birth-weight premature infants, with COPE infants scoring 100.3 compared to 93.9 for comparison infants at 3 months, and a 14-point advantage at 6 months.

Mothers participating in the COPE program reported lower stress levels related to the NICU environment and had a better understanding of their infants' needs, suggesting that the program also positively impacted maternal coping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Melnyk, BM., Alpert-Gillis, L., Feinstein, NF., et al.[2022]

The intervention during infancy, known as Playing and Learning Strategies (PALS I), significantly improved maternal emotional and cognitive responsiveness, positively impacting infant development.

For optimal results in fostering responsive parenting, a second intervention during the toddler-preschool period (PALS II) was necessary, particularly for enhancing cognitive responsive behaviors and adapting to children's changing signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A responsive parenting intervention: the optimal timing across early childhood for impacting maternal behaviors and child outcomes. Landry, SH., Smith, KE., Swank, PR., et al.[2022]

A new intervention program has been developed specifically for parents of moderate to late preterm infants to enhance parent-infant interactions, which are crucial for the infants' development and attachment.

The program provides real-time feedback to parents during care routines, helping them recognize and respond to their infant's cues, with ongoing clinical studies assessing its effectiveness and parental experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. Helmer, CS., Thornberg, UB., Mörelius, E.[2021]

The Internet-based adaptation of the Play and Learning Strategies (PALS) program significantly improved parenting knowledge and language-supportive behaviors among 164 low-income families, demonstrating its effectiveness as a remote intervention.

Increased dosage of the intervention correlated with more pronounced positive changes in both parenting practices and infant language behaviors, highlighting the importance of engagement in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized control trial of an internet-based parenting intervention for mothers of infants. Feil, EG., Baggett, K., Davis, B., et al.[2021]

Interventions aimed at changing parenting styles for parents of preterm and high-risk infants are diverse and primarily focus on enhancing parental responsivity and sensitivity, but they vary widely in timing, outcomes, and costs.

While most studies report short-term outcomes for children under 2 years old, some research indicates that these interventions can lead to improved cognitive and behavioral outcomes in prekindergarten and school-aged children, suggesting long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting Style Interventions in Parents of Preterm and High-Risk Infants: Controversies, Cost, and Future Directions. Neel, ML.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Impact of a two-generation early education program on parenting processes at age 18. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Randomised trial of a parenting intervention during neonatal intensive care. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

A responsive parenting intervention: the optimal timing across early childhood for impacting maternal behaviors and child outcomes. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized control trial of an internet-based parenting intervention for mothers of infants. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Parenting Style Interventions in Parents of Preterm and High-Risk Infants: Controversies, Cost, and Future Directions. [2023]