Protocol and Preliminary Findings from the BrainPALS Study in Very Preterm Children: A Randomized Controlled Trial of a Digital Parenting Program
Abstract
Background/Objectives: Children born very preterm (VPT; <33 weeks gestation) are at increased risk for atypical neurodevelopment and deficits in self-regulation, including executive function (EF) and emotion regulation (ER). Responsive parenting interventions, such as Play and Learning Strategies (PALS), improve caregiver behavior; however, their effects on neurodevelopmental outcomes in VPT populations remain limited. This study describes a randomized controlled trial evaluating a digital adaptation of PALS (ePALS). Methods: Families of toddlers aged 15–28 months born very preterm were randomized to either the ePALS intervention or an active control condition. Assessments were conducted at pre-test and post-test to evaluate caregiver responsiveness, child EF and ER, and neural development using behavioral tasks, EEG, and MRI. Results: To date, 84 families have been randomized (43 ePALS, 41 control). Preliminary findings indicate that parents in the ePALS condition demonstrate greater improvements in responsiveness compared to the control group. Intervention adherence rates are reported. Conclusions: These findings support the feasibility and preliminary efficacy of a digitally delivered parenting intervention for improving caregiver responsiveness in families of VPT toddlers. Ongoing analyses will evaluate long-term behavioral and neurodevelopmental outcomes.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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