COMPLETED

Preschool Attention and Sleep Support (PASS)

Conditions

ADHD Psychiatric Health Children Preschool Telehealth Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-24

Study Completion:2026-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05862727

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 5 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Jessica Lunsford-Avery, PhD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27705

United States

Collaborators and Investigators

Sponsor: Duke University

Jessica Lunsford-Avery, PhD, PRINCIPAL_INVESTIGATOR, Duke University

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

Study Start Date2023-07-24

Study Completion Date2026-01-30

Study Record Updates

Study Start Date2023-07-24

Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

Psychiatric Health
Children
Preschool
ADHD
Telehealth Intervention

Additional Relevant MeSH Terms

ADHD
Psychiatric Health