AzTrials
AzTrials

ADHDPASSNCT05862727

Preschool Attention and Sleep Support (PASS)

A study testing Telehealth Intervention in people with ADHD and Psychiatric Health, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 3 to 5 years
Conditions the study is for
ADHD, Psychiatric Health
What is being tested?
Telehealth Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
24 Jul 2023to 30 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

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

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.

Read the detailed description

During Aim 2, caregivers of preschool children with ADHD symptoms will be randomly assigned to participate in one of two 9-week telehealth interventions. Both interventions will teach evidence-based skills and provide practice opportunities to manage their children's ADHD-related behaviors. Caregivers and their children will also attend three study visits (one before the intervention, and two following the intervention) where they will be asked to complete questionnaires and assessments related to the child's ADHD symptoms, psychiatric health, and sleep habits. Following each study visit, participating children will be asked to wear an ActiGraph device on their nondominant wrist for 24 hours/day for a 7-day period. During this time, the caregivers will be asked to complete an electronic daily diary about their child's sleep.

Being tested
Telehealth Intervention
Keywords
Psychiatric Health, Children, Preschool, ADHD, Telehealth Intervention
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehealth InterventionBehavioural

    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.

Study groups in NCT05862727
Study groupRoleWhat they receive
PASS Arm1ExperimentalCaregivers 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.
Receives: Behavioral: Telehealth Intervention
PASS Arm2Active comparatorCaregivers 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.
Receives: Behavioral: Telehealth Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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

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

Secondary outcomes (6)

  1. Change in psychosocial function as measured by Impairment Rating Scale

    A clinician rated, 8-item assessment with a 7-point Likert scale ranging from No problem; definitely does not need treatment/special services to Extreme Problem; definitely needs treatment/special services. Lower scores indicate better outcomes.

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

  2. Change in parenting stress as measured by the Parenting Stress Scale

    An 18-item questionnaire with a 5-point Likert Scale ranging from Strongly disagree to Strongly Agree. Lower scores indicate better outcomes.

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

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

    A widely-used 99-item parent report questionnaire with a 3-point Likert Scale ranging from Not True to Very True or Often True. Lower scores indicate better outcomes.

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

  4. 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).

    As measured via actigraphy collected continuously over 7 days.

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

  5. Change in parenting style as measured by the Alabama Parenting Questionnaire

    A 33-item questionnaire with a 5-point Likert Scale ranging from Never to Always.

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

  6. Change in severity of behavior problems in the home setting as measured by the Home Situations Questionnaires.

    A 16-item questionnaire with a 9-point Likert Scale. Lower scores indicate better outcomes.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start24 Jul 2023
  3. Primary completion30 Jan 2026
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Behavioral Telehealth Intervention
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05862727
Sponsor's protocol ID
Pro00111845
Other IDs
R34MH131994-01
Acronym
PASS
Status last verified
Jan 2026
First submitted
3 Apr 2023
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.

Publications

  • 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.

    PubMed 41728023

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth Intervention in people with ADHD and Psychiatric Health, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in clinician-rated ADHD-RS (time frame: Baseline, immediately post-treatment, 3 months post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05862727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Preschool Attention and Sleep Support (PASS) | AzTrials