Status:
UNKNOWN
Parents Advancing Toddler Health
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
University of Denver
University of Michigan
Conditions:
Sleep Problem
Behavior, Child
Eligibility:
All Genders
18-48 years
Phase:
NA
Brief Summary
Although early interventions can improve health equity in young children living in poverty, this promise often is not realized because of barriers to family engagement. The proposed study will target ...
Detailed Description
Children living in poverty have a high incidence of early-developing sleep and behavior problems, which are often co-morbid. Early sleep and behavior problems are prevalent and persistent risk factors...
Eligibility Criteria
Inclusion
- child age at enrollment of 18-48 months;
- household income at or below 300% of the federal poverty line
- a parent fluent in English or Spanish
- child behavior problem as indicated by a score \> 60 on the Emotionally Reactive, Anxious/Depressed, Withdrawn, Attention Problems, or Aggressive Behavior subscales of the Child Behavior Checklist 1 ½ - 5 years (CBCL 1 ½ - 5)
- child sleep problem as indicated by at least one of the following: score 1 standard deviation above community means on any subscale of the Children's Sleep Wake Scale or on the Sleep Anxiety subscale of the Children's Sleep Habits Questionnaire; nighttime sleep latency longer than 30 minutes; score \>40 on the Children's Sleep Habits Questionnaire (CSHQ); bedtimes or wake times varying by more than 2 hours from day to day; and/or nighttime sleep duration ≤ 9.5 hr.
Exclusion
- Diagnosed developmental disabilities
- Serious chronic medical conditions such as autoimmune disorders or cancer
- A positive screen on the Sleep Disordered Breathing or Parasomnia subscales of the CSHQ or parent-reported diagnosis of obstructive sleep apnea
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04824989
Start Date
March 22 2021
End Date
April 30 2025
Last Update
April 4 2022
Active Locations (2)
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1
University of Denver
Denver, Colorado, United States, 80208
2
Boston University
Boston, Massachusetts, United States, 02215