Parents Advancing Toddler Health

Behavior, Child Clinical Trial

— PATH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824989
• Other study ID #: 1R01HD098167-01A1
• Secondary ID: 5554E
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2022
• Source: Boston University Charles River Campus
• Contact: Amanda R Tarullo, Ph.D.
• Phone: 617-353-3688
• Email: atarullo[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Child
• Dyssomnias
• Parasomnias
• Sleep Problem

Intervention

Behavioral:
• Sleep Health in Preschoolers (SHIP)
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.
• Family Check-Up (FCU)
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.
• Oral Health, Child Safety, and Environmental Health Intervention (Active Control)
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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts
United States	University of Denver	Denver	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Denver Health and Hospital Authority, University of Colorado, Boulder, University of Denver, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (10)

Campbell SB. Behavior problems in preschool children: a review of recent research. J Child Psychol Psychiatry. 1995 Jan;36(1):113-49. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in Children's Sleep Hygiene Scale (CSHS) from baseline to one month	Parent report assessing sleep inhibiting and sleep facilitating behaviors	Change from baseline to one month post-intervention
Secondary	Change in Children's Sleep Hygiene Scale (CSHS) from baseline to five months	Parent report assessing sleep inhibiting and sleep facilitating behaviors	Change from baseline to five months post-intervention
Secondary	Change in Children's Sleep Hygiene Scale (CSHS) from baseline to nine months	Parent report assessing sleep inhibiting and sleep facilitating behaviors	Change from baseline to nine months post-intervention
Secondary	Change in Parenting Sense of Competence (PSOC) from baseline to one month	Parent report assessing parental perceived efficacy, a dimension of family functioning	Change from baseline to one month post-intervention
Secondary	Change in Parenting Sense of Competence (PSOC) from baseline to five months	Parent report assessing parental perceived efficacy, a dimension of family functioning	Change from baseline to five months post-intervention
Secondary	Change in Parenting Sense of Competence (PSOC) from baseline to nine months	Parent report assessing parental perceived efficacy, a dimension of family functioning	Change from baseline to nine months post-intervention
Secondary	Change in Peds QL Family Impact Module from baseline to one month	Parent report assessing family functioning	Change from baseline to one month post-intervention
Secondary	Change in Peds QL Family Impact Module from baseline to five months	Parent report assessing family functioning	Change from baseline to five months post-intervention
Secondary	Change in Peds QL Family Impact Module from baseline to nine months	Parent report assessing family functioning	Change from baseline to nine months post-intervention