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Sleep-Focused Parenting Intervention for Preschoolers with ADHD (OASIS Trial)
N/A
Recruiting
Led By Heather M Joseph, DO
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: 3-5 years of age
Parent/Caregiver: English speaking
Must not have
Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline up to 8 months
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two parent behavioral interventions to help 3-5 year olds with sleep and ADHD symptoms.
Who is the study for?
This trial is for English-speaking children aged 3-5 who show signs of ADHD and sleep problems, as reported by their legal guardians. Guardians must be at least 18 years old. Children with severe neurodevelopmental disorders or sleep issues due to medical conditions like narcolepsy or obstructive sleep apnea cannot participate.
What is being tested?
The study compares two parenting interventions: a brief behavioral one and a modified version focused on improving the child's sleep (SF-PBI). It aims to see which is more acceptable, feasible, appropriate, and effective in reducing ADHD symptoms and improving sleep among preschoolers.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication, traditional side effects are not expected. However, there may be changes in family dynamics or stress levels as parents implement new strategies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 3 and 5 years old.
Select...
I, as a parent/caregiver, can speak English.
Select...
I am between 3 and 5 years old.
Select...
I speak English.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a medical condition like narcolepsy or sleep apnea that affects my sleep.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline up to 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline up to 8 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ADHD Symptoms
Intervention Acceptability
Intervention Appropriateness
+2 moreSecondary study objectives
Consistency of Bedtime Routine
Nighttime Awakenings
Sleep Latency
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep-Focused Parent Behavioral InterventionExperimental Treatment1 Intervention
A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.
Group II: Brief Parent Behavioral InterventionActive Control1 Intervention
A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,573 Total Patients Enrolled
2 Trials studying Oppositional Defiant Disorder
290 Patients Enrolled for Oppositional Defiant Disorder
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,740,083 Total Patients Enrolled
12 Trials studying Oppositional Defiant Disorder
2,989 Patients Enrolled for Oppositional Defiant Disorder
Heather M Joseph, DOPrincipal InvestigatorAssistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 3 and 5 years old.My legal guardian is 18 years old or older.I have a medical condition like narcolepsy or sleep apnea that affects my sleep.I, as a parent/caregiver, can speak English.My legal guardian is 18 years old or older.My child speaks English.The person taking care of you has noticed that you have at least 4 symptoms of ADHD.I am between 3 and 5 years old.You must be able to speak English.I speak English.A caregiver has reported that the child has 4 or more symptoms of ADHD.You have a serious developmental disorder related to the nervous system.The caregiver reports that the child has one or more sleep problems.My caregiver has noticed I have sleep issues.
Research Study Groups:
This trial has the following groups:- Group 1: Brief Parent Behavioral Intervention
- Group 2: Sleep-Focused Parent Behavioral Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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