Optimizing Attention and Sleep Intervention Study

Part of paid clinical trials in Cranberry Township, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05683756
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • Brief Parent Behavioral Intervention — BEHAVIORAL
    PBI administered in pediatric primary care by an embedded therapist.
  • Sleep-Focused Parent Behavioral Intervention — BEHAVIORAL
    SF-PBI administered in pediatric primary care by an embedded therapist.

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Brief Parent Behavioral Intervention
    A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.
  • Experimental: Sleep-Focused Parent Behavioral Intervention
    A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.

Primary Outcome Measure

Intervention Acceptability [ Time Frame: Post Intervention at approximately 4 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Children's Community Pediatrics Bass Wolfson, CranberryCranberry TownshipPennsylvania16066-
Children's Community Pediatrics GIL MurrysvilleMonroevillePennsylvania15146-
Children's Community Pediatrics NeshannockNew CastlePennsylvania16105-
Children's Community Pediatrics ShenangoNew CastlePennsylvania16101-
Children's Community Pediatrics Bass Wolfson, Squirrel HillPittsburghPennsylvania15217-
Children's Community Pediatrics GIL East LibertyPittsburghPennsylvania15206-
University of PittsburghPittsburghPennsylvania15213-

Find similar trials in Cranberry Township, PA

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
Children's Community Pediatrics Bass Wolfson, Cranberry· Cranberry Township, PAChildren's Community Pediatrics GIL Murrysville· Monroeville, PAChildren's Community Pediatrics Neshannock· New Castle, PAChildren's Community Pediatrics Shenango· New Castle, PAChildren's Community Pediatrics Bass Wolfson, Squirrel Hill· Pittsburgh, PAChildren's Community Pediatrics GIL East Liberty· Pittsburgh, PA

Related Studies