Preschool Attention and Sleep Support (PASS)
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.
Conditions:
🦠 ADHD 🦠 Psychiatric Health
🗓️ Study Start (Actual) 24 July 2023
🗓️ Primary Completion (Estimated) 10 May 2025
✅ Study Completion (Estimated) 10 May 2025
👥 Enrollment (Estimated) 44
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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.

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 3 Years to 5 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 April 2023
  • First Submitted that Met QC Criteria 8 May 2023
  • First Posted 17 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified May 2024