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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

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.Check my eligibility
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.See study design
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 below
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My child is between 3 and 5 years old.
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I, as a parent/caregiver, can speak English.
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I am between 3 and 5 years old.
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I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a medical condition like narcolepsy or sleep apnea that affects my sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline up to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline up to 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADHD Symptoms
Intervention Acceptability
Intervention Appropriateness
+2 more
Secondary outcome measures
Consistency of Bedtime Routine
Nighttime Awakenings
Sleep Latency

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.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,737 Previous Clinical Trials
16,339,207 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,769 Total Patients Enrolled
Heather M Joseph, DOPrincipal InvestigatorAssistant Professor of Psychiatry and Pediatrics, University of Pittsburgh

Media Library

Brief Parent Behavioral Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05683756 — N/A
Preschoolers Research Study Groups: Brief Parent Behavioral Intervention, Sleep-Focused Parent Behavioral Intervention
Preschoolers Clinical Trial 2023: Brief Parent Behavioral Intervention Highlights & Side Effects. Trial Name: NCT05683756 — N/A
Brief Parent Behavioral Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683756 — N/A
~31 spots leftby Sep 2025
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