Preschool Attention and Sleep Support (PASS)

Study Overview
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Brief Summary
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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.

Detailed Description
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During Aim 2, caregivers of preschool children with ADHD symptoms will be randomly assigned to participate in one of two 8-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.

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

Conditions
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ADHD, Psychiatric Health

Intervention / Treatment
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* Behavioral: Telehealth Intervention


Participation Criteria
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Eligibility Criteria
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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 are not currently participating in another parent training intervention and have not previously participated in another parent training intervention in the past 6 months.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Behavioral Telehealth Intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PASS Arm1<br>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<br>* 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.<br>|
| Active Comparator: PASS Arm2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, immediately post-treatment, 3 months post-treatment | 
| 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. | Baseline, immediately post-treatment, 3 months post-treatment | 
| 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. | 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). | As measured via actigraphy collected continuously over 7 days. | Baseline, immediately post-treatment, 3 months post-treatment | 
| 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. | Baseline, immediately post-treatment, 3 months post-treatment | 
| 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. | Baseline, immediately post-treatment, 3 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatric Health, Children, Preschool, ADHD, Telehealth Intervention