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Behavioral Intervention
Sensory Intervention for Sleep Issues in ADHD
N/A
Recruiting
Led By Amy G Hartman, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child aged 6-10 years
A reported clinical diagnosis of ADHD or suspected ADHD and 6+ items endorsed as "quite a bit" or "very much" a single domain on SNAP-IV (ADHD symptomology questionnaire)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate if children with ADHD who have trouble sleeping may be more sensitive to sensory input. The study will look at how this sensitivity affects their ability to fall asleep and stay asleep. Researchers
Who is the study for?
This trial is for children aged 6-10 with ADHD who have trouble settling down to sleep, taking more than 20 minutes. They must have a clinical diagnosis or show significant symptoms of ADHD and their caregiver must be involved in all bedtimes during the intervention. Participants need to visit the lab in Pittsburgh.
What is being tested?
The study tests an intervention called 'Power Down manipulation' designed to help children with ADHD relax before bedtime by addressing sensory over-responsivity—a condition where normal sensory input causes stress—and its effect on sleep problems.
What are the potential side effects?
Since this is a behavioral intervention focusing on relaxation techniques, there are no direct medical side effects like those seen with medication. However, individual responses to therapy may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 6 and 10 years old.
Select...
I have been diagnosed with ADHD or show strong ADHD symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and after 2 week intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 2 week intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in sleep disturbances
Daily bedtime arousal level
Daily bedtime emotion dysregulation
+6 moreSecondary study objectives
Change in sleep difficulties
Change in sleep related impairment
Circadian preference
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Settle down to sleepExperimental Treatment1 Intervention
All participants will engage in a 1 week home-based baseline measurement, 1 lab visit for training and measurement, and 2 week intervention trial.
Find a Location
Who is running the clinical trial?
The Klingenstein Third Generation FoundationOTHER
5 Previous Clinical Trials
1,353 Total Patients Enrolled
University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,956 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,430 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Amy G Hartman, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
10 Total Patients Enrolled