Parents Advancing Toddler Health

Status unconfirmed · Not applicable

Conditions studied: Sleep Problem, Behavior, Child

In brief

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 co-morbid behavior and sleep problems in early childhood, comparing child outcomes and family response to sleep and behavior interventions and investigating the novel strategy of letting families select their intervention.We will enroll 500 low-income toddlers with co-morbid sleep and behavior problems, randomized to 4 parent coaching interventions: sleep, behavior, family choice (sleep or behavior), and an active control. At baseline and at 1, 5, and 9 months post- intervention, we will assess child sleep and behavior and family functioning. We will measure family preference, engagement, and perceived value of each intervention. The goals of the study are: (1) to examine effects of evidence- based sleep and behavior interventions in young low-income children with co-morbid sleep and behavior problems on child sleep and behavior and family functioning; (2) to determine whether parents prefer, engage with, and value a sleep or behavior intervention more; and (3) to examine if giving families a choice of intervention results in higher engagement, higher perceived value and better family and child outcomes than assignment to intervention. By informing best practices for engaging low-income families to treat co-morbid sleep and behavior problems, results will be critical to reducing health disparities for children living in poverty.

Key facts

Study ID

NCT04824989

Run by

Boston University Charles River Campus

People needed

500

Starts

2021-03-22

Expected to finish

2025-04-30

Last updated by the study team

2022-04-04

Who can join

Age: 2 and older, up to 4. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 60 on the Emotionally Reactive, Anxious/Depressed, Withdrawn, Attention Problems, or Aggressive Behavior subscales of the Child Behavior Checklist 1 ½ - 5 years (CBCL 1 ½ - 5)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.

You may not qualify if…

• 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

Where it is running

• University of Denver — Denver, Colorado, United States (enrolling)
• Boston University — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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