Clinical trial NCT04824989: Parents Advancing Toddler Health
Official title: Advancing Engagement and Efficacy of Interventions for Co-Morbid Sleep and Behavior Problems in Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Problem
Behavior, Child
Keywords: sleep problems
behavior problems
parenting interventions
early childhood
poverty
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of Denver
name: University of Michigan
name: Denver Health and Hospital Authority
name: University of Colorado, Boulder
First posted: 2021-04-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families are randomly assigned to one of four groups for an 8-week parent coaching intervention program: focus on (1) child sleep, (2) child behavior, (3) parent choice of child sleep or child behavior, (4) active control - safety \& hygiene
Primary purpose: TREATMENT

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 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.

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 for lifelong poor mental and physical health outcomes, and may be key mechanisms underlying early and enduring socioeconomic health disparities. While effective interventions exist, low-income families have low enrollment and retention in these interventions. Stigma of treating behavior problems creates an additional barrier to treatment. This RCT aims to address these barriers to treatment for low-income children with co-morbid sleep and behavior problems. Sleep and behavior problems and family dysfunction transact across time, increasing in severity, while healthy sleep, positive child behaviors, and effective parenting can support each other across development. Thus we posit that intervention in one domain, either sleep or behavior, may improve outcomes both within and across domains.

The proposed study is a parallel randomized controlled trial of behavioral treatments for sleep problems and behavior problems in early childhood. The current study will test our three key aims: that evidence based sleep and behavior interventions each will improve trajectories from early comorbid sleep and behavior problems to healthier outcomes (Aim 1); that family preference, engagement, and value may differ for sleep vs. behavior interventions (Aim 2); and that families who choose between sleep and behavior interventions will have a more positive family response and better outcomes than those assigned to an intervention (Aim 3). This study will enroll 500 low income children ages 24 to 48 months with comorbid sleep and behavior problems. Children will be recruited at Boston University and the University of Denver. Eligible participants will be randomized to one of four intervention arms, Behavior (FCU), Sleep (SHIP), Choice (FCU or SHIP, as selected by primary caregiver), and active Control (Oral Health, Child Safety, and Environmental Health). For those assigned to Choice, the primary caregiver will be provided information about FCU and SHIP and will select their preferred intervention.

At the baseline evaluation (T1) all participants will undergo the following procedures: a) An evaluation of child behavior b) an evaluation of child sleep c) an evaluation of family functioning. Following the baseline evaluation all participants will engage in 8 sessions of parent coaching intervention over a 2 month period, with the content of the intervention varying by intervention arm, see descriptions below. The SHIP and FCU have similar structure, emphasizing motivational interviewing and support for parent goals. Paraprofessional staff at each site will be trained to deliver the FCU, SHIP, and Control interventions.

The measures included in the T1 baseline evaluation will be repeated at 1 and 5 months post intervention, T2 and T3. At T4, 9 months post intervention, primary caregiver report of child behavior and sleep symptoms and family functioning will be collected via telephone interview.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Child Behavior Checklist (CBCL) from screening to one month
timeFrame: Change from screening to one month post-intervention
measure: Change in Child Behavior Checklist (CBCL) from screening to five months
timeFrame: Change from screening to five months post-intervention
measure: Change in Child Behavior Checklist (CBCL) from screening to nine months
timeFrame: Change from screening to nine months post-intervention
measure: Change in Emotion Regulation Checklist (ERC) from baseline to one month
timeFrame: Change from baseline to one month post-intervention
measure: Change in Emotion Regulation Checklist (ERC) from baseline to five months
timeFrame: Change from baseline to five months post-intervention
measure: Change in Emotion Regulation Checklist (ERC) from baseline to nine months
timeFrame: Change from baseline to nine months post-intervention
measure: Change in Children's Sleep Wake Scale (CSWS) from screening to one month
timeFrame: Change from screening to one month post-intervention
measure: Change in Children's Sleep Wake Scale (CSWS) from screening to five months
timeFrame: Change from screening to five months post-intervention
measure: Change in Children's Sleep Wake Scale (CSWS) from screening to nine months
timeFrame: Change from screening to nine months post-intervention
measure: Change in nighttime sleep minutes from baseline to one month as measured by actigraphy
timeFrame: Change from baseline to one month post-intervention
measure: Change in nighttime sleep minutes from baseline to five months as measured by actigraphy
timeFrame: Change from baseline to five months post-intervention
measure: Change in sleep onset from baseline to one month as measured by actigraphy
timeFrame: Change from baseline to one month post-intervention
measure: Change in sleep onset from baseline to five months as measured by actigraphy
timeFrame: Change from baseline to five months post-intervention
measure: Change in sleep consistency from baseline to one month as measured by actigraphy
timeFrame: Change from baseline to one month post-intervention
measure: Change in sleep consistency from baseline to five months as measured by actigraphy
timeFrame: Change from baseline to five months post-intervention
Secondary outcomes:
measure: Change in Children's Sleep Hygiene Scale (CSHS) from baseline to one month
timeFrame: Change from baseline to one month post-intervention
measure: Change in Children's Sleep Hygiene Scale (CSHS) from baseline to five months
timeFrame: Change from baseline to five months post-intervention
measure: Change in Children's Sleep Hygiene Scale (CSHS) from baseline to nine months
timeFrame: Change from baseline to nine months post-intervention
measure: Change in Parenting Sense of Competence (PSOC) from baseline to one month
timeFrame: Change from baseline to one month post-intervention
measure: Change in Parenting Sense of Competence (PSOC) from baseline to five months
timeFrame: Change from baseline to five months post-intervention
measure: Change in Parenting Sense of Competence (PSOC) from baseline to nine months
timeFrame: Change from baseline to nine months post-intervention
measure: Change in Peds QL Family Impact Module from baseline to one month
timeFrame: Change from baseline to one month post-intervention
measure: Change in Peds QL Family Impact Module from baseline to five months
timeFrame: Change from baseline to five months post-intervention
measure: Change in Peds QL Family Impact Module from baseline to nine months
timeFrame: Change from baseline to nine months post-intervention
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Denver
state: Colorado
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Amanda R Tarullo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garrison MM. The feedback whirlpool of early childhood sleep and behavior problems. JAMA Pediatr. 2015 Jun;169(6):525-6. doi: 10.1001/jamapediatrics.2015.0356. No abstract available.
citation: El-Sheikh M, Buckhalt JA, Mark Cummings E, Keller P. Sleep disruptions and emotional insecurity are pathways of risk for children. J Child Psychol Psychiatry. 2007 Jan;48(1):88-96. doi: 10.1111/j.1469-7610.2006.01604.x.
citation: Campbell SB. Behavior problems in preschool children: a review of recent research. J Child Psychol Psychiatry. 1995 Jan;36(1):113-49. doi: 10.1111/j.1469-7610.1995.tb01657.x.
citation: Jackson CL, Redline S, Emmons KM. Sleep as a potential fundamental contributor to disparities in cardiovascular health. Annu Rev Public Health. 2015 Mar 18;36:417-40. doi: 10.1146/annurev-publhealth-031914-122838.
citation: LeBourgeois MK, Harsh JR. Development and psychometric evaluation of the Children's Sleep-Wake Scale<sup/> Sleep Health. 2016 Sep;2(3):198-204. doi: 10.1016/j.sleh.2016.04.001.
citation: Shields A, Cicchetti D. Emotion regulation among school-age children: the development and validation of a new criterion Q-sort scale. Dev Psychol. 1997 Nov;33(6):906-16. doi: 10.1037//0012-1649.33.6.906.
citation: Wilson KE, Lumeng JC, Kaciroti N, Chen SY, LeBourgeois MK, Chervin RD, Miller AL. Sleep Hygiene Practices and Bedtime Resistance in Low-Income Preschoolers: Does Temperament Matter? Behav Sleep Med. 2015;13(5):412-23. doi: 10.1080/15402002.2014.940104. Epub 2014 Sep 15.
citation: Sivertsen B, Harvey AG, Reichborn-Kjennerud T, Torgersen L, Ystrom E, Hysing M. Later emotional and behavioral problems associated with sleep problems in toddlers: a longitudinal study. JAMA Pediatr. 2015 Jun;169(6):575-82. doi: 10.1001/jamapediatrics.2015.0187.
citation: Shaw DS, Shelleby EC. Early-starting conduct problems: intersection of conduct problems and poverty. Annu Rev Clin Psychol. 2014;10:503-28. doi: 10.1146/annurev-clinpsy-032813-153650.
citation: Mulraney M, Giallo R, Lycett K, Mensah F, Sciberras E. The bidirectional relationship between sleep problems and internalizing and externalizing problems in children with ADHD: a prospective cohort study. Sleep Med. 2016 Jan;17:45-51. doi: 10.1016/j.sleep.2015.09.019. Epub 2015 Oct 23.