NCT05862727

Preschool Attention and Sleep Support (PASS)

Preschool Attention and Sleep Support (PASS): A Telehealth Intervention for Children at Risk for ADHD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

This study will be investigating two telehealth interventions for preschoolers with ADHD. The study is divided into two Aims. During Aim 1, caregivers of preschoolers with attention concerns, pediatric behavioral health professionals, and pediatric primary care providers will take part in two virtual focus groups to provide their perspective on ways to improve the telehealth intervention being evaluated.

Detailed description

During Aim 2, caregivers of preschool children with ADHD symptoms will be randomly assigned to participate in one of two 9-week telehealth interventions. Both interventions will teach evidence-based skills and provide practice opportunities to manage their children's ADHD-related behaviors. Caregivers and their children will also attend three study visits (one before the intervention, and two following the intervention) where they will be asked to complete questionnaires and assessments related to the child's ADHD symptoms, psychiatric health, and sleep habits. Following each study visit, participating children will be asked to wear an ActiGraph device on their nondominant wrist for 24 hours/day for a 7-day period. During this time, the caregivers will be asked to complete an electronic daily diary about their child's sleep.

Conditions

• ADHD
• Psychiatric Health

Interventions

Type	Name	Description
BEHAVIORAL	Telehealth Intervention	Telehealth intervention that teaches caregivers evidence-based skills and provides practice opportunities to manage their children's ADHD-related behaviors according to their assigned intervention.

Timeline

• Start date: 2023-07-24
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2023-05-17
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States