RECRUITING

Parents Advancing Toddler Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Advancing Engagement and Efficacy of Interventions for Co-Morbid Sleep and Behavior Problems in Young Children

Quick Facts

Study Start:2021-03-22
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04824989

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Months to 48 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * child age at enrollment of 18-48 months;
  2. * household income at or below 300% of the federal poverty line
  3. * a parent fluent in English or Spanish
  4. * 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)
  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.
  1. * Diagnosed developmental disabilities
  2. * Serious chronic medical conditions such as autoimmune disorders or cancer
  3. * A positive screen on the Sleep Disordered Breathing or Parasomnia subscales of the CSHQ or parent-reported diagnosis of obstructive sleep apnea

Contacts and Locations

Study Contact

Amanda R Tarullo, Ph.D.
CONTACT
617-353-3688
atarullo@bu.edu
Sarah Watamura, Ph.D.
CONTACT
303-871-4130
swatamura@du.edu

Principal Investigator

Amanda R Tarullo, Ph.D.
PRINCIPAL_INVESTIGATOR
Boston University

Study Locations (Sites)

University of Denver
Denver, Colorado, 80208
United States
Boston University
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

  • Amanda R Tarullo, Ph.D., PRINCIPAL_INVESTIGATOR, Boston University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-22
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2021-03-22
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • sleep problems
  • behavior problems
  • parenting interventions
  • early childhood
  • poverty

Additional Relevant MeSH Terms

  • Sleep Problem
  • Behavior, Child