Sleep-Focused Parent Behavioral Intervention for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Attention Deficit Hyperactivity Disorder (ADHD)+4 MoreSleep-Focused Parent Behavioral Intervention - Behavioral
Eligibility
3 - 5
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Preschoolers
  • Sleep
  • Sleep Disorder

Treatment Effectiveness

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: Change from baseline up to 8 months

Month 8
ADHD Symptoms
Consistency of Bedtime Routine
Nighttime Awakenings
Problematic Sleep
Sleep Latency
Month 4
Intervention Acceptability
Intervention Appropriateness
Intervention Feasibility

Trial Safety

Trial Design

2 Treatment Groups

Brief Parent Behavioral Intervention
1 of 2
Sleep-Focused Parent Behavioral Intervention
1 of 2

Active Control

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Sleep-Focused Parent Behavioral Intervention · No Placebo Group · N/A

Sleep-Focused Parent Behavioral Intervention
Behavioral
Experimental Group · 1 Intervention: Sleep-Focused Parent Behavioral Intervention · Intervention Types: Behavioral
Brief Parent Behavioral Intervention
Behavioral
ActiveComparator Group · 1 Intervention: Brief Parent Behavioral Intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline up to 8 months

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,617 Previous Clinical Trials
16,299,799 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
870 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,555 Previous Clinical Trials
1,822,335 Total Patients Enrolled
91 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
19,895 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Heather M Joseph, DOPrincipal InvestigatorAssistant Professor of Psychiatry and Pediatrics, University of Pittsburgh

Eligibility Criteria

Age 3 - 5 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your legal guardian must be at least 18 years old in order to be eligible for the study.
You are between the ages of 3-5 years.
Your caregiver reported that you have at least four symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
A caregiver has reported one or more issues with your sleep habits.

Who else is applying?

What state do they live in?
California100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%