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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04856501
Status
Recruiting
Apply to this trial

Conditions

  • Premature Birth

Eligibility Criteria

Sex
ALL
Age
15 Months - 30 Months
Healthy Volunteers
Not accepted

Interventions

  • PALS intervention condition — 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 — 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.

Study Details

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.

Key Dates

Start date
Aug 7, 2020
Status verified
Mar 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PALS intervention condition
  • Active Comparator: Control condition

Primary Outcome Measure

Change in Parental contingent responsiveness as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Dana DeMaster, PhD
[email protected]
(713) 500-8315
Kelly Vaughn
[email protected]
713-500-8243
Susan Landry (PRINCIPAL_INVESTIGATOR)
Johanna Bick (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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