Telehealth support for preschoolers with ADHD and sleep issues
Preschool Attention and Sleep Support (PASS): A Telehealth Intervention for Children at Risk for ADHD
This study tests two online programs to see if they can help preschoolers with ADHD and sleep problems by teaching their caregivers useful skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05862727 on ClinicalTrials.gov |
What this trial studies
This study investigates two telehealth interventions aimed at helping preschoolers with ADHD. It consists of two main aims: the first involves focus groups with caregivers and healthcare professionals to gather insights on improving the telehealth intervention. The second aim randomly assigns caregivers of preschool children with ADHD symptoms to one of two 9-week telehealth programs that teach evidence-based skills for managing ADHD-related behaviors. Participants will also engage in assessments related to ADHD symptoms, psychiatric health, and sleep habits throughout the study.
Who should consider this trial
Good fit: Ideal candidates are preschool children aged 3-5 years with ADHD symptoms and sleep problems.
Not a fit: Patients with suspected obstructive sleep apnea or those currently using stimulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective telehealth strategies for managing ADHD and improving sleep in preschoolers.
How similar studies have performed: Other studies have shown promise in using telehealth interventions for ADHD management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Lunsford-Avery, PhD — Duke University
- Study coordinator: Matt Gibson
- Email: matthew.gibson646@duke.edu
- Phone: 919-681-2521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.