Parents Advancing Toddler Health

NCT04824989 | Unknown DMC

• 2 other identifiers: 1R01HD098167-01A15554E
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Problem; Behavior, Child

Keywords

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

Outcome Measures

Primary Outcomes (15)

• Change in Child Behavior Checklist (CBCL) from screening to one month

  This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales

  Change from screening to one month post-intervention

• Change in Child Behavior Checklist (CBCL) from screening to five months

  This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales

  Change from screening to five months post-intervention

• Change in Child Behavior Checklist (CBCL) from screening to nine months

  This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales

  Change from screening to nine months post-intervention

• Change in Emotion Regulation Checklist (ERC) from baseline to one month

  Parent report assessing intensity, flexibility, and appropriateness of child emotions

  Change from baseline to one month post-intervention

• Change in Emotion Regulation Checklist (ERC) from baseline to five months

  Parent report assessing intensity, flexibility, and appropriateness of child emotions

  Change from baseline to five months post-intervention

• Change in Emotion Regulation Checklist (ERC) from baseline to nine months

  Parent report assessing intensity, flexibility, and appropriateness of child emotions

  Change from baseline to nine months post-intervention

• Change in Children's Sleep Wake Scale (CSWS) from screening to one month

  Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness

  Change from screening to one month post-intervention

• Change in Children's Sleep Wake Scale (CSWS) from screening to five months

  Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness

  Change from screening to five months post-intervention

• Change in Children's Sleep Wake Scale (CSWS) from screening to nine months

  Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness

  Change from screening to nine months post-intervention

• Change in nighttime sleep minutes from baseline to one month as measured by actigraphy

  The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of nighttime sleep minutes. Data are analyzed using Actiware software.

  Change from baseline to one month post-intervention

• Change in nighttime sleep minutes from baseline to five months as measured by actigraphy

  The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of nighttime sleep minutes. Data are analyzed using Actiware software.

  Change from baseline to five months post-intervention

• Change in sleep onset from baseline to one month as measured by actigraphy

  The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep onset. Data are analyzed using Actiware software.

  Change from baseline to one month post-intervention

• Change in sleep onset from baseline to five months as measured by actigraphy

  The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep onset. Data are analyzed using Actiware software.

  Change from baseline to five months post-intervention

• Change in sleep consistency from baseline to one month as measured by actigraphy

  The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep consistency (consistency in sleep timing from night to night). Data are analyzed using Actiware software.

  Change from baseline to one month post-intervention

• Change in sleep consistency from baseline to five months as measured by actigraphy

  The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep consistency (consistency in sleep timing from night to night). Data are analyzed using Actiware software.

  Change from baseline to five months post-intervention

Secondary Outcomes (9)

• Change in Children's Sleep Hygiene Scale (CSHS) from baseline to one month

  Change from baseline to one month post-intervention

• Change in Children's Sleep Hygiene Scale (CSHS) from baseline to five months

  Change from baseline to five months post-intervention

• Change in Children's Sleep Hygiene Scale (CSHS) from baseline to nine months

  Change from baseline to nine months post-intervention

• Change in Parenting Sense of Competence (PSOC) from baseline to one month

  Change from baseline to one month post-intervention

• Change in Parenting Sense of Competence (PSOC) from baseline to five months

  Change from baseline to five months post-intervention

Study Arms (4)

Sleep Health

EXPERIMENTAL

Family receives the Sleep Health In Preschoolers parenting intervention to address toddler sleep problems.

Behavioral: Sleep Health in Preschoolers (SHIP)

Behavior Health

EXPERIMENTAL

Family receives the Family Check-Up parenting intervention to address toddler behavior problems.

Behavioral: Family Check-Up (FCU)

Choice

EXPERIMENTAL

Family is given the opportunity to select either the Sleep Health in Preschoolers intervention to address toddler sleep problems or the Family Check-Up intervention to address toddler behavior problems.

Behavioral: Sleep Health in Preschoolers (SHIP); Behavioral: Family Check-Up (FCU)

Control

ACTIVE COMPARATOR

Family receives a safety and hygiene active control intervention.

Behavioral: Oral Health, Child Safety, and Environmental Health Intervention (Active Control)

Interventions

Sleep Health in Preschoolers (SHIP) BEHAVIORAL

SHIP is an 8 session home visiting intervention to reduce child sleep problems using a framework that draws from motivational interviewing and social cognitive theory, and effectively improves sleep timing, duration, and quality. Following ecological assessment of child sleep and sleep routines, feedback is provided on family strengths and challenges in the child sleep domain, with motivational interviewing to increase parent knowledge of sleep, correct misperceptions, and raise outcomes expectations. The remaining sessions are targeted modules that give tailored feedback and education, and coach the parent in setting manageable goals, identifying action steps, anticipating barriers, and supporting positive behaviors. Targets: bedtime scheduling, consistency, and routines; media use, independent sleep onset, nightmares and fears, night wakings, and early waking; sleep location, nap issues, engaging other caregivers.

Choice; Sleep Health

Family Check-Up (FCU) BEHAVIORAL

FCU is an 8 session home visiting intervention to reduce behavior problems for children through improved parenting. Over 30 years of research establishes its efficacy in reducing behavioral and emotional problems, including in low income toddlers. Following ecological assessment of behavior management and child behavior, family receives feedback on family strengths and challenges within the behavioral domain via a motivational interviewing approach. The remaining sessions are targeted modules drawn from the Everyday Parenting curriculum, individualized based on parent goals and identified challenge areas. Each session begins by establishing a collaborative skill set, involves teaching the rationale for a skill, teaching and modeling effective use of the skill, and then role play and experiential practice to coach the parent to success. Targets can include Positive Behavior Support, Limit Setting and Monitoring, Family Routines, Communication, and Problem Solving.

Behavior Health; Choice

Oral Health, Child Safety, and Environmental Health Intervention (Active Control) BEHAVIORAL

This intervention serves as an active control condition to ensure that observed effects are due to the intervention content, rather than to study processes, staff attention, or general support and problem solving. The intervention is designed to be comparable to SHIP and FCU in intensity, personal contact, session structure and approach, but focused on Oral Health, Child Safety, and Environmental Health, domains which should not immediately affect study outcomes.

Control

Eligibility Criteria

• Age: 18 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• University of Denver: collaborator
• University of Michigan: collaborator
• Denver Health and Hospital Authority: collaborator
• University of Colorado, Boulder: collaborator

Study Sites (2)

University of Denver

Denver, Colorado, 80208, United States

RECRUITING

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 25868054 BACKGROUND

• 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.

  PMID: 17244274 BACKGROUND

• 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.

  PMID: 7714027 BACKGROUND

• 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.

  PMID: 25785893 BACKGROUND

• 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.

  PMID: 28066802 BACKGROUND

• 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.

  PMID: 9383613 BACKGROUND

• 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.

  PMID: 25221914 BACKGROUND

• 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.

  PMID: 25867179 BACKGROUND

• 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.

  PMID: 24471370 BACKGROUND

• 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.

  PMID: 26847973 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Child Behavior; Mental Disorders

Interventions

Oral Health

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Amanda R Tarullo, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda R Tarullo, Ph.D.

CONTACT

617-353-3688; atarullo@bu.edu

Sarah Watamura, Ph.D.

CONTACT

303-871-4130; swatamura@du.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are blind to participant assignment. Participant and Care Provider cannot be blind as the assignment determines the focus of the intervention received (sleep, behavior, choice, or safety/hygiene).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 4, 2022

Record last verified: 2022-04

Locations

US (2)