A Sleep Focused Parenting Intervention for Preschool Aged Children at Risk for ADHD

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms. The main aims are to: Demonstrate acceptability, feasibility, and appropriateness of the SF-PBI. Examine change in sleep and ADHD symptoms among preschoolers with ADHD symptoms receiving SF-PBI compared to the brief PBI.

Detailed Description
-----------------
Sleep problems may be one mechanism through which young children may be at risk for developing ADHD, although first line ADHD interventions, including parent behavioral interventions (PBIs), do not address sleep. Investigators will test a modified version of a PBI to target sleep disrupting behaviors for children 3-5 years old at elevated risk for ADHD. The intervention will be delivered by behavioral health therapists embedded in pediatric primary care to increase families' access to intervention. This pilot effectiveness trial is the first step towards developing an early intervention targeting sleep as a mechanism to reduce the prevalence, symptoms, and impairments associated with childhood ADHD.

Official Title
-----------------
A Parent Behavioral Intervention Targeting Sleep Among Preschool Aged Children at Elevated Risk for Attention-Deficit/Hyperactivity Disorder (ADHD): A Pilot Effectiveness Trial in Pediatric Primary Care

Conditions
-----------------
Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool, Sleep, Sleep Disturbance

Intervention / Treatment
-----------------
* Behavioral: Brief Parent Behavioral Intervention
* Behavioral: Sleep-Focused Parent Behavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent/Caregiver: (1) Legal guardian is at least 18 years of age (2) English speaking Child: (1) 3-5 years of age (2) Caregiver report of 4 or more ADHD symptoms (3) Caregiver report of one or more sleep problems (4) English speaking. Exclusion Criteria: (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea) (2) Severe neurodevelopmental disorder

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief Parent Behavioral Intervention<br>A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD. | Behavioral: Brief Parent Behavioral Intervention<br>* PBI administered in pediatric primary care by an embedded therapist.<br>|
| Experimental: Sleep-Focused Parent Behavioral Intervention<br>A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors. | Behavioral: Sleep-Focused Parent Behavioral Intervention<br>* SF-PBI administered in pediatric primary care by an embedded therapist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability | Therapists and caregiver report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good acceptability. | Post Intervention at approximately 4 months | 
| Intervention Appropriateness | Therapists and caregiver report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good appropriateness. | Post Intervention at approximately 4 months | 
| Intervention Feasibility | Therapists and caregiver report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good feasibility. | Post Intervention at approximately 4 months | 
| Problematic Sleep | Using the Brief Child Sleep Questionnaire caregivers will report on their perception of child's sleep as problematic, rated 1 (Not at all) to 5 (A serious problem). | Change from baseline up to 8 months | 
| ADHD Symptoms | Using the 18-item ADHD Rating Scale-IV-Preschool Version caregivers will report on the child's ADHD symptoms. Symptoms are rated from 0 (Rarely) to 3 (Very Often). | Change from baseline up to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nighttime Awakenings | Caregivers will report how many times their child typically wakes during the night, using the Brief Child Sleep Questionnaire. | Change from baseline up to 8 months | 
| Sleep Latency | Sleep latency will be determined by using the caregiver report of how long it typically takes their child to fall asleep (number of minutes), using the Brief Child Sleep Questionnaire. | Change from baseline up to 8 months | 
| Consistency of Bedtime Routine | Caregivers will report the number of days, in a typical week, they regularly put their child to bed at the same time (within 15 minutes), using the Brief Child Sleep Questionnaire. | Change from baseline up to 8 months |