Preschool Attention and Sleep Support (PASS)

Completed · Not applicable

Conditions studied: ADHD, Psychiatric Health

In brief

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.

Key facts

Study ID

NCT05862727

Run by

Duke University

People needed

46

Starts

2023-07-24

Expected to finish

2026-01-30

Last updated by the study team

2026-02-04

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• child must be ages 3-5 years at intake
• child with score of 30 on the Child Sleep Habits Survey-Short Form and a caregiver rating of child's sleep problems as moderate/severe
• child with ≥80th percentile on the clinician-rated ADHD-RS based on age and sex norms, with at least 4 symptoms in the clinically significant range (scores of 2-3) in either the inattention or hyperactive/impulsive domains
• parent/caregiver must have ability to speak, read, and write in English
• parent/caregiver must have access to a device with internet and/or smartphone to access telehealth visits
• parent/caregiver must have ability to follow written and verbal instructions
• parent/caregiver must have ability and willingness to comply with study procedures.

You may not qualify if…

• child with suspected obstructive sleep apnea or restless legs syndrome (via screening questionnaires)
• child with current use of stimulant medication, other psychotropics, or medications for sleep (prescription or over-the-counter, including melatonin)
• child with caregiver report of psychiatric disorder other than ADHD requiring treatment (medication and/or therapy), Autism Spectrum Disorder, or intellectual disability
• parent/caregiver is currently participating in another parent training intervention or have previously participated in another parent training intervention in the past 6 months.
• Severe and/or uncontrolled medical condition (e.g., pulmonary and neurological conditions such as cystic fibrosis and seizure disorder) that would interfere with sleep and/or study participation according to the study team

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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