Preschool Attention and Sleep Support (PASS)

NCT05862727 | Completed

• 2 other identifiers: Pro00111845R34MH131994-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD; Psychiatric Health

Keywords

Psychiatric Health; Children; Preschool; ADHD; Telehealth Intervention

Outcome Measures

Primary Outcomes (3)

• Change in clinician-rated ADHD-RS

  A clinician-rated, 18-item assessment with a 4-point Likert scale ranging from Rarely or never to Very Often. Lower scores indicate better outcomes.

  Baseline, immediately post-treatment, 3 months post-treatment

• Change in caregiver-reported sleep habits as measured by the Short-Form Child Sleep Habits Questionnaire (SF-CSHQ).

  A 23-item questionnaire with a 3-point Likert scale ranging from Rarely to Usually. Lower scores indicate better outcomes.

  Baseline, immediately post-treatment, 3 months post-treatment

• Change in Sleep Regularity Index (SRI)

  A measure of sleep regularity collected continuously over 7 days via Actigraphy. The SRI is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status

  Baseline, immediately post-treatment, 3 months post-treatment

Secondary Outcomes (6)

• Change in psychosocial function as measured by Impairment Rating Scale

  Baseline, immediately post-treatment, 3 months post-treatment

• Change in parenting stress as measured by the Parenting Stress Scale

  Baseline, immediately post-treatment, 3 months post-treatment

• Change in comorbid symptoms as measured by Child Behavioral Checklist for Ages 1½ to 5(CBCL)

  Baseline, immediately post-treatment, 3 months post-treatment

• Change in sleep midpoint, TST (minutes from sleep start to sleep end), SOL (minutes to first sleep epoch), WASO (minutes awake between sleep start and sleep end), and SE (TST/time in bed).

  Baseline, immediately post-treatment, 3 months post-treatment

• Change in parenting style as measured by the Alabama Parenting Questionnaire

  Baseline, immediately post-treatment, 3 months post-treatment

Other Outcomes (11)

• Treatment Fidelity

  During the 9-week treatment

• Feasibility of Recruitment

  Baseline

• Feasibility of Randomization

  Baseline

Study Arms (2)

PASS Arm1

EXPERIMENTAL

Caregivers will receive sessions of evidence-based behavioral parent training which focuses on improving behaviors, such as establishing daytime and bedtime routines, through enhancement of positive parenting skills, including modifying antecedents, applying/withdrawing positive attention as a consequence, and shaping behavior using salient rewards.

Behavioral: Telehealth Intervention

PASS Arm2

ACTIVE COMPARATOR

Caregivers will receive sessions of evidence-based behavioral parent training which focuses on improving behaviors, including in home and public settings, through enhancement of positive parenting skills, including modifying antecedents, applying/withdrawing positive attention as a consequence, and shaping behavior using salient rewards.

Behavioral: Telehealth Intervention

Interventions

Telehealth Intervention BEHAVIORAL

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.

PASS Arm1; PASS Arm2

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Davis NO, Eichner B, Gibson MJ, Lunsford-Avery JR. Preschool attention and sleep support (PASS): protocol for a pilot feasibility randomized clinical trial. Front Sleep. 2026 Feb 6;4:1662221. doi: 10.3389/frsle.2025.1662221. eCollection 2025.

  PMID: 41728023 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jessica Lunsford-Avery, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to one of two interventions, and will not be told which intervention they are assigned to. Outcomes assessor will also be blinded to intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Behavioral Telehealth Intervention

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 17, 2023
• Study Start: July 24, 2023
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be accessible by researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals and questions for data access should be directed to NDAHelp@mail.nih.gov. To gain access, data requestors will need to sign a data access agreement at https://nda.nih.gov/nda/access-data-info.html.

Locations

US (1)