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Preschool attention and sleep support (PASS): protocol for a pilot feasibility randomized clinical trial
Naomi O Davis1, Brian Eichner2, Matthew J Gibson1
1Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, United States.
Insights
This study tested a new intervention combining behavioral parent training (BPT) and behavioral sleep medicine (BSM) for preschoolers at risk for Attention-Deficit/Hyperactivity Disorder (ADHD). The combined approach aims to improve ADHD symptoms and sleep by targeting biological mechanisms.
Area of Science:
- Pediatric Psychology
- Neurodevelopmental Disorders
- Sleep Medicine
Background:
- Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms frequently emerge in preschool, necessitating early preventative interventions.
- Current behavioral parent training (BPT) for ADHD primarily addresses daytime symptoms, overlooking sleep dysregulation.
- Integrating behavioral sleep medicine (BSM) into BPT may enhance interventions by targeting 24-hour behavioral patterns and underlying biological mechanisms.
Purpose of the Study:
- To evaluate the feasibility and acceptability of a combined BPT and BSM intervention (Preschool Attention and Sleep Support, PASS) for preschoolers at risk for ADHD.
- To assess the impact of the PASS intervention on ADHD symptoms and sleep patterns compared to standard BPT.
- To gather preliminary data for a larger clinical trial of the PASS intervention.
Main Methods:
- A randomized trial involving 44 children aged 3-5 years with elevated ADHD symptoms.
- Participants were assigned to either standard BPT or the combined PASS intervention (BPT + BSM).
- Assessments of ADHD symptoms, sleep, and functional outcomes were conducted at baseline, post-treatment, and 3-month follow-up.
Main Results:
- Key outcomes measured include changes in ADHD symptoms via clinical and caregiver ratings.
- Sleep patterns were assessed using actigraphy and caregiver reports.
- Exploratory outcomes include changes in comorbid symptoms and parenting stress.
Conclusions:
- Findings will inform the design of a large-scale clinical trial for the PASS intervention.
- The study aims to improve functional outcomes in preschoolers at risk for ADHD.
- Early, biologically-focused preventative interventions are crucial for modifying ADHD trajectories.
Introduction:
Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms often emerge during preschool, highlighting a critical period for prevention. Preventative ADHD interventions may be most effective if they target biological mechanisms linked to core ADHD pathophysiology. Sleep dysregulation represents a potential target, yet the gold-standard behavioral intervention (behavioral parent training, BPT) focuses primarily on ameliorating daytime impairment. There is a critical need to adapt BPT to target behaviors across the 24-h period through integration with behavioral sleep medicine (BSM).
Methods:
This trial will randomize children ages 3-5 years who are identified as at-risk for ADHD (i.e., with elevated ADHD symptoms) and their caregivers to receive either BPT (n = 22) or a combined intervention that includes BPT and BSM (Preschool Attention and Sleep Support, PASS; n = 22). Blinded assessments will be conducted at baseline, immediately post-treatment, and 3 months post treatment. Feasibility and acceptability will be assessed.
Results:
Key outcomes will include changes in ADHD symptoms (measured by clinical and caregiver rating) and sleep (measured by both actigraphy and caregiver report). Changes in additional functional outcomes (e.g., comorbid symptoms, parenting stress) will be explored.
Discussion:
Findings from this study will provide essential data to inform a large-scale clinical trial of PASS, with the ultimate goal of improving functional outcomes among preschoolers at risk for ADHD and modifying the trajectory of this chronic condition through early preventative intervention focused on improving biological processes linked to ADHD.
Trial Registration:
NCT05862727.
