Clinical trial NCT05683756: Optimizing Attention and Sleep Intervention Study
Official title: Optimizing Attention and Sleep Intervention Study: a Pilot RCT to Compare Parent Behavioral Interventions with and Without Sleep Strategies Delivered in Pediatric Primary Care for Preschool-aged Children At Risk of Childhood ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Hyperactivity Disorder
Child, Preschool
Sleep
Sleep Disturbance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Acceptability
timeFrame: Post Intervention at approximately 4 months
measure: Intervention Appropriateness
timeFrame: Post Intervention at approximately 4 months
measure: Intervention Feasibility
timeFrame: Post Intervention at approximately 4 months
measure: Problematic Sleep
timeFrame: Change from baseline up to 8 months
measure: ADHD Symptoms
timeFrame: Change from baseline up to 8 months
Secondary outcomes:
measure: Nighttime Awakenings
timeFrame: Change from baseline up to 8 months
measure: Sleep Latency
timeFrame: Change from baseline up to 8 months
measure: Consistency of Bedtime Routine
timeFrame: Change from baseline up to 8 months
Other outcomes:
measure: Actigraphy
timeFrame: Change from baseline up to 8 months
measure: Sleep Diary
timeFrame: Change from baseline up to 8 months
Locations:
city: Cranberry Township
country: United States
facility: Children's Community Pediatrics Bass Wolfson, Cranberry
state: Pennsylvania
city: Monroeville
country: United States
facility: Children's Community Pediatrics GIL Murrysville
state: Pennsylvania
city: New Castle
country: United States
facility: Children's Community Pediatrics Shenango
state: Pennsylvania
city: New Castle
country: United States
facility: Children's Community Pediatrics Neshannock
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Community Pediatrics GIL East Liberty
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Community Pediatrics Bass Wolfson, Squirrel Hill
state: Pennsylvania
Study officials:
affiliation: Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
name: Heather M Joseph, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham CE, Bremner R, Boyle M. Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome. J Child Psychol Psychiatry. 1995 Oct;36(7):1141-59. doi: 10.1111/j.1469-7610.1995.tb01362.x.