Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
46 participants
INTERVENTIONAL
2023-07-24
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PASS Arm1
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.
Telehealth Intervention
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 Arm2
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.
Telehealth Intervention
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.
Interventions
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Telehealth Intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
3 Years
5 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Jessica Lunsford-Avery, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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Pro00111845
Identifier Type: -
Identifier Source: org_study_id