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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-07

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PALS intervention condition

Group Type EXPERIMENTAL

PALS intervention condition

Intervention Type BEHAVIORAL

The Play and Learning Strategies (PALS) intervention provides parents with behaviors that, collectively, are known as a responsive parenting style. Four constructs make up this responsive parenting style: 1) contingent responsiveness, (responses are conditionally linked to the child's signals) 2) warm sensitivity (high levels of affection and understanding of child states), 3) maintaining vs. redirecting attention, and 4) verbal scaffolding (providing child appropriate language supports). Parents assigned to this intervention will be paired with a coach who will guide them through the program over the course of 9 weekly sessions. The intervention (ePALS) will be implemented via an internet adaptation through the Children's Learning Institute's ENGAGE platform. However, ePALS could easily be adapted for other platforms and accessed with any web-enabled device.

Control condition

Group Type ACTIVE_COMPARATOR

Control condition

Intervention Type BEHAVIORAL

Families assigned to the control condition will be provided with a website with information corresponding to milestones of toddler development. Control families will be asked to review that week's materials before the each of the 9 weekly coach calls. The active control condition serves three important purposes: 1) Maintains an active line of communication and accurate contact records for Post-test 1 and Post-test 2 session scheduling; 2) Masks participant's awareness of intervention vs. control assignment; and 3) Approximates communication with intervention staff such that results showing ePALS effects are attributable to intervention rather than regular communication with an interventionist.

Interventions

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PALS intervention condition

The Play and Learning Strategies (PALS) intervention provides parents with behaviors that, collectively, are known as a responsive parenting style. Four constructs make up this responsive parenting style: 1) contingent responsiveness, (responses are conditionally linked to the child's signals) 2) warm sensitivity (high levels of affection and understanding of child states), 3) maintaining vs. redirecting attention, and 4) verbal scaffolding (providing child appropriate language supports). Parents assigned to this intervention will be paired with a coach who will guide them through the program over the course of 9 weekly sessions. The intervention (ePALS) will be implemented via an internet adaptation through the Children's Learning Institute's ENGAGE platform. However, ePALS could easily be adapted for other platforms and accessed with any web-enabled device.

Intervention Type BEHAVIORAL

Control condition

Families assigned to the control condition will be provided with a website with information corresponding to milestones of toddler development. Control families will be asked to review that week's materials before the each of the 9 weekly coach calls. The active control condition serves three important purposes: 1) Maintains an active line of communication and accurate contact records for Post-test 1 and Post-test 2 session scheduling; 2) Masks participant's awareness of intervention vs. control assignment; and 3) Approximates communication with intervention staff such that results showing ePALS effects are attributable to intervention rather than regular communication with an interventionist.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- Maternal age over 18-years when child was born

Exclusion Criteria

* presence of known/suspected congenital anomalies including chromosomal or complex congenital heart disease
* congenital infection including TORCH (Toxoplasmosis, Rubella, Cytomegalovirus, Herpes Simplex and others),untreated maternal HIV, or maternal syphilis
* bilateral grade 3/4 intraventricular hemorrhage,intraparenchymal hemorrhage, hydrocephalus
* Cerebral palsy with Gross Motor Function Classification of III or higher
* blindness-
* deafness
* Current maternal drug use or maternal drug use during pregnancy
* families who reside outside the catchment area (\>1 hour drive from the Texas Medical Center)
* Child with contraindication for MRI. If the mother of the child is pregnant, thinks she might be pregnant, or has a contraindication for MRI, another relative of the child will be asked to assist with the MRIs

Minimum Eligible Age

15 Months

Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No