RECRUITING

Optimizing Attention and Sleep Intervention Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-12-01
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05683756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * (1) Legal guardian is at least 18 years of age
  2. * (2) Reads and speaks English
  3. * (1) 3-5 years of age
  4. * (2) Caregiver report of 4 or more ADHD symptoms
  5. * (3) Caregiver reports child's sleep as a "moderate" or "serious problem"
  6. * (4) English speaking
  7. * (5) Child receives care from participating pediatric primary care office
  1. * (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
  2. * (2) Severe neurodevelopmental disorder

Contacts and Locations

Study Contact

Heather M Joseph, DO
CONTACT
4122465338
liebherrh@upmc.edu

Principal Investigator

Heather M Joseph, DO
PRINCIPAL_INVESTIGATOR
Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh

Study Locations (Sites)

Children's Community Pediatrics Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, 16066
United States
Children's Community Pediatrics GIL Murrysville
Monroeville, Pennsylvania, 15146
United States
Children's Community Pediatrics Shenango
New Castle, Pennsylvania, 16101
United States
Children's Community Pediatrics Neshannock
New Castle, Pennsylvania, 16105
United States
Children's Community Pediatrics GIL East Liberty
Pittsburgh, Pennsylvania, 15206
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Children's Community Pediatrics Bass Wolfson, Squirrel Hill
Pittsburgh, Pennsylvania, 15217
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Heather M Joseph, DO, PRINCIPAL_INVESTIGATOR, Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

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