Preschool Attention and Sleep Support (PASS)

Duke University

Status: Enrolling

Conditions: Psychiatric Health; ADHD

Treatments: Behavioral: Telehealth Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05862727

R34MH131994-01 (U.S. NIH Grant/Contract)

Pro00111845

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

PASS Arm1

Experimental group

Description:

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.

Treatment:

Behavioral: Telehealth Intervention

PASS Arm2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telehealth Intervention