Optimizing Attention and Sleep Intervention Study (OASIS)

University of Pittsburgh

Status: Enrolling

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

Treatments: Behavioral: Brief Parent Behavioral Intervention; Behavioral: Sleep-Focused Parent Behavioral Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05683756

R34MH131993 (Other Grant/Funding Number)

STUDY22070096

Details and patient eligibility

About

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:

Aim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD.

Aim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Parent/Caregiver:

• (1) Legal guardian is at least 18 years of age
• (2) Reads and speaks English

Child:

• (1) 3-5 years of age
• (2) Caregiver report of 4 or more ADHD symptoms
• (3) Caregiver reports child's sleep as a "moderate" or "serious problem"
• (4) English speaking
• (5) Child receives care from participating pediatric primary care office

Exclusion criteria

• (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
• (2) Severe neurodevelopmental disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Brief Parent Behavioral Intervention

Active Comparator group

Description:

A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.

Treatment:

Behavioral: Brief Parent Behavioral Intervention

Sleep-Focused Parent Behavioral Intervention

Experimental group

Description:

A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.

Treatment:

Behavioral: Sleep-Focused Parent Behavioral Intervention