Sleep Health in Preschoolers (SHIP) for Dyssomnias

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Denver, Denver, CO
Dyssomnias+3 More
Sleep Health in Preschoolers (SHIP) - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Dyssomnias

Study Summary

This study is evaluating whether a sleep and behavior intervention may help improve outcomes for young children living in poverty.

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Eligible Conditions

  • Dyssomnias
  • Parasomnias
  • Children Behavior
  • Sleep disorders and disturbances

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Sleep Health in Preschoolers (SHIP) will improve 15 primary outcomes and 9 secondary outcomes in patients with Dyssomnias. Measurement will happen over the course of Change from baseline to one month post-intervention.

Change from baseline to five months post-intervention
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to five months
Change in Emotion Regulation Checklist (ERC) from baseline to five months
Change in Parenting Sense of Competence (PSOC) from baseline to five months
Change in Peds QL Family Impact Module from baseline to five months
Change in nighttime sleep minutes from baseline to five months as measured by actigraphy
Change in sleep consistency from baseline to five months as measured by actigraphy
Change in sleep onset from baseline to five months as measured by actigraphy
Change from baseline to nine months post-intervention
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to nine months
Change in Emotion Regulation Checklist (ERC) from baseline to nine months
Change in Parenting Sense of Competence (PSOC) from baseline to nine months
Change in Peds QL Family Impact Module from baseline to nine months
Change from baseline to one month post-intervention
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to one month
Change in Emotion Regulation Checklist (ERC) from baseline to one month
Change in Parenting Sense of Competence (PSOC) from baseline to one month
Change in Peds QL Family Impact Module from baseline to one month
Change in nighttime sleep minutes from baseline to one month as measured by actigraphy
Change in sleep consistency from baseline to one month as measured by actigraphy
Change in sleep onset from baseline to one month as measured by actigraphy
Change from screening to five months post-intervention
Change in Child Behavior Checklist (CBCL) from screening to five months
Change in Children's Sleep Wake Scale (CSWS) from screening to five months
Change from screening to nine months post-intervention
Change in Child Behavior Checklist (CBCL) from screening to nine months
Change in Children's Sleep Wake Scale (CSWS) from screening to nine months
Change from screening to one month post-intervention
Change in Child Behavior Checklist (CBCL) from screening to one month
Change in Children's Sleep Wake Scale (CSWS) from screening to one month

Trial Safety

Trial Design

4 Treatment Groups

Control
Sleep Health

This trial requires 500 total participants across 4 different treatment groups

This trial involves 4 different treatments. Sleep Health In Preschoolers (SHIP) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Sleep Health
Behavioral
Family receives the Sleep Health In Preschoolers parenting intervention to address toddler sleep problems.
Behavior Health
Behavioral
Family receives the Family Check-Up parenting intervention to address toddler behavior problems.
ChoiceFamily 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.
Control
Behavioral
Family receives a safety and hygiene active control intervention.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to five months post-intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to five months post-intervention for reporting.

Closest Location

University of Denver - Denver, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study found that enrolling children aged 18-48 months significantly improved their cognitive, language, and social skills. show original
The text states that a household's income must be at or below 300% of the federal poverty line in order to be eligible for financial assistance. show original
A bilingual/bicultural parent is one who can fluently communicate in both English and Spanish. show original
A child who scores more than 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) may have a behavior problem. show original
The child has a sleep problem if he or she has a 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; if nighttime sleep latency is longer than 30 minutes; if the score on the Children's Sleep Habits Questionnaire (CSHQ) is greater than 40; if bedtimes or wake times vary by more than 2 hours from day to day; and/or if nighttime sleep duration is less than 9.5 hours. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of dyssomnias?

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Patients with dyssomnias present with an intermittent, often alarming and recurrent insomnia with symptoms including restlessness, headaches, increased sweating and decreased appetite. These are often accompanied by sleep-related and other disturbances. Patients should be evaluated for sleep disorders particularly when their sleep habits are abnormal. Sleep disorders should be included in the differential diagnosis of hypersomnia.

Unverified Answer

What are common treatments for dyssomnias?

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The majority of prescribed medications are used only when symptoms are severe or for the treatment of secondary symptoms such as agitation, which are not the primary purpose of the medication and therefore may not be required, even though they have proven effectiveness in alleviating such symptoms.

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Can dyssomnias be cured?

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Dysfunctions of sleep-wake states can be assessed objectively and adequately treated. Although some patients are able to sleep again without symptoms, many need to learn to sleep independently or to sleep for longer periods.

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What causes dyssomnias?

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The prevalence of dyssomnias was low. In the large majority of cases, the cause was unknown. In these cases, a nonclinical genetic basis was unlikely. Only small-or moderate-size studies are needed before excluding an important genetic risk factor.

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How many people get dyssomnias a year in the United States?

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It is estimated that there are more than 5 million patients with an undiagnosed and untreated sleep-wake disorder in the United States. These patients are, however, not adequately recognized or studied. This project is intended to highlight the importance of sleep medicine among neurology and general medicine doctors. Results from a recent clinical trial could also be used to make future recommendations and plans for conducting better studies of sleep disorders among the medical community.

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What is dyssomnias?

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Diagnosis of dyssomnias can be challenging and may require special diagnostic consideration. Sleep researchers, clinicians, and researchers in mood disorders are encouraged to seek appropriate diagnostic evaluation.

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Has sleep health in preschoolers (ship) proven to be more effective than a placebo?

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Findings from this project demonstrate the positive impacts that a sleep intervention can produce for children by fostering improved sleep structure and processes and reducing sleep complaints.

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What does sleep health in preschoolers (ship) usually treat?

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Sleep patterns were less uniform and more complex than would normally be expected in preschooler and older children. A significant proportion of preschooler sleep patterns are different from that in older children. Sleep patterns did not differ by age or sex. However, sleep disturbances did differ.

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What is the primary cause of dyssomnias?

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Although we used a small sample size, [this study confirms studies that have found that a variety of factors seem to be associated with the development of a chronic pain disorder and that may also play a role in the initiation of symptoms, particularly in the case of idiopathic dyssomnias. These factors include a past stressful experience or traumatic life event, which can modify the activity of NREM sleep generating centers in the brain; other factors include neurological risk factors, genetic traits, and lifestyle factors. The effects that these factors have on the development of dyssomnias are not clear.

Unverified Answer

What is the average age someone gets dyssomnias?

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Dyssomnias happen more commonly in childhood than in old age. The onset of dyssomnias often occurs around age 6, and it is rarely mentioned in the literature. Recent findings are important when clinicians discuss the diagnosis of dyssomnias with patients.

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Have there been other clinical trials involving sleep health in preschoolers (ship)?

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We found evidence that the effect of sleep is age and sex specific. While we found no statistically significant relationship between sleep and health behaviors, sleeping habits, and circadian rhythm, our results did show no increase of problems in sleep, and sleep quality was worse in the daytime.

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Is sleep health in preschoolers (ship) typically used in combination with any other treatments?

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In a recent study, findings demonstrated the effectiveness of the Sleep Health Project as an educational and motivational strategy in changing the attitudes and knowledge of parents toward sleep in young children. The Sleep Health Project was also effective with improving parents' attitudes and intentions within the pediatric setting to implement sleep patterns and strategies in their children. It was also successfully adopted by the staff of the NICU. In a recent study, findings demonstrated that the Sleep Health Project can be administered as an educational intervention at the nursery and that it may be a tool to reduce sleep problems in the preschool age, and to increase caregivers' knowledge and acceptance of sleep problems in young children.

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