Sleep Clinical Trial
— OASISOfficial title:
A Parent Behavioral Intervention Targeting Sleep Among Preschool Aged Children at Elevated Risk for Attention-Deficit/Hyperactivity Disorder (ADHD): A Pilot Effectiveness Trial in Pediatric Primary Care
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2026 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 5 Years |
Eligibility | Inclusion Criteria: Parent/Caregiver: - (1) Legal guardian is at least 18 years of age - (2) English speaking Child: - (1) 3-5 years of age - (2) Caregiver report of 4 or more ADHD symptoms - (3) Caregiver report of one or more sleep problems - (4) English speaking. Exclusion Criteria: - (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea) - (2) Severe neurodevelopmental disorder |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute of Mental Health (NIMH) |
United States,
Cunningham CE, Bremner R, Boyle M. Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome. J Child Psychol Psychiatry. 1995 Oct;36(7):1141-59. doi: 10.1111/j.1469-7610.1995.tb01362.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention Acceptability | Therapists and caregiver report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good acceptability. | Post Intervention at approximately 4 months | |
Primary | Intervention Appropriateness | Therapists and caregiver report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good appropriateness. | Post Intervention at approximately 4 months | |
Primary | Intervention Feasibility | Therapists and caregiver report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good feasibility. | Post Intervention at approximately 4 months | |
Primary | Problematic Sleep | Using the Brief Child Sleep Questionnaire caregivers will report on their perception of child's sleep as problematic, rated 1 (Not at all) to 5 (A serious problem). | Change from baseline up to 8 months | |
Primary | ADHD Symptoms | Using the 18-item ADHD Rating Scale-IV-Preschool Version caregivers will report on the child's ADHD symptoms. Symptoms are rated from 0 (Rarely) to 3 (Very Often). | Change from baseline up to 8 months | |
Secondary | Nighttime Awakenings | Caregivers will report how many times their child typically wakes during the night, using the Brief Child Sleep Questionnaire. | Change from baseline up to 8 months | |
Secondary | Sleep Latency | Sleep latency will be determined by using the caregiver report of how long it typically takes their child to fall asleep (number of minutes), using the Brief Child Sleep Questionnaire. | Change from baseline up to 8 months | |
Secondary | Consistency of Bedtime Routine | Caregivers will report the number of days, in a typical week, they regularly put their child to bed at the same time (within 15 minutes), using the Brief Child Sleep Questionnaire. | Change from baseline up to 8 months |
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