What is the mechanism of action of this treatment?

Behavioral modification and sleep training are common treatments for sleep disorders that focus on changing behaviors and habits that negatively impact sleep. Behavioral modification involves techniques such as stimulus control, which helps patients associate the bed with sleep rather than wakefulness, and sleep restriction, which limits time in bed to increase sleep efficiency. Sleep training often includes establishing a consistent sleep schedule and creating a bedtime routine to signal the body that it is time to sleep. Understanding these mechanisms is crucial for patients because it empowers them to make lifestyle changes that can improve their sleep quality and overall health without relying solely on medication.

What side effects are associated with this type of intervention?

Behavioral modifications and sleep training are common non-pharmacologic treatments for sleep disorders. These interventions generally have minimal side effects compared to pharmacologic treatments. However, some potential side effects include initial resistance or increased anxiety in children as they adjust to new routines, temporary sleep disturbances, and possible stress for parents implementing the interventions. Overall, these side effects are typically mild and transient, making behavioral approaches a preferred first-line treatment for sleep disorders.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of sleep disorders, including sodium oxybate for narcolepsy in children and adults. Other medications like solriamfetol and pitolisant have also been approved for narcolepsy in adults. However, there are no FDA-approved medications specifically for pediatric insomnia, and pharmacologic interventions in children often rely on data from adult studies or pediatric case reports. Behavioral interventions, such as those being studied in the Parent Coaching Interventions trial, focus on sleep training and behavioral modification, which are critical for managing sleep disorders in children without relying solely on pharmacotherapy.

What other types of research exist?

Promising novel alternatives to Parent Coaching Interventions for sleep disorders include: 1) Cognitive Behavioral Therapy for Insomnia (CBTI), which has been shown to be effective in various populations including veterans. 2) Technology-enhanced delivery of CBT-based interventions, such as web-based training and smartphone applications, which have demonstrated efficacy in improving sleep outcomes. 3) Mind-body therapies like guided imagery, hypnosis, and biofeedback, which are used to treat a variety of pediatric conditions including sleep disorders. These alternatives offer flexible and accessible treatment options that can complement traditional behavioral modification and sleep training.

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Parental Interventions for Toddler Sleep and Behavior Support (PATH Trial)

N/A

Recruiting

Led By Amanda R Tarullo, Ph.D.

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child age at enrollment of 18-48 months

Be younger than 18 years old

Must not have

Serious chronic medical conditions such as autoimmune disorders or cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to five months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial trains parents of low-income toddlers with sleep and behavior problems to manage these issues through coaching sessions. The goal is to improve the child's sleep and behavior, leading to better family functioning.

Who is the study for?

This trial is for low-income toddlers aged 18-48 months with both sleep and behavior problems. The child must have a specific score on the Child Behavior Checklist, indicating issues like being overly emotional or aggressive. Parents need to speak English or Spanish fluently, and household income should be at or below 300% of the federal poverty line.

What is being tested?

The study compares four parent coaching interventions: one focused on sleep, another on behavior, a third where families choose between sleep or behavior intervention, and an active control group focusing on oral health and safety. It aims to see which approach works best for improving children's sleep/behavior and family functioning.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, there are no direct physical side effects expected from the treatments themselves. However, changes in routine could temporarily affect the child's mood or stress levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 18 and 48 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious chronic condition like an autoimmune disorder or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to nine months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to nine months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to nine months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+12 more

Secondary study objectives

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

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

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

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Sleep HealthExperimental Treatment1 Intervention

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

Group II: ChoiceExperimental Treatment2 Interventions

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.

Group III: Behavior HealthExperimental Treatment1 Intervention

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

Group IV: ControlActive Control1 Intervention

Family receives a safety and hygiene active control intervention.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral modification and sleep training are common treatments for sleep disorders that focus on changing behaviors and habits that negatively impact sleep. Behavioral modification involves techniques such as stimulus control, which helps patients associate the bed with sleep rather than wakefulness, and sleep restriction, which limits time in bed to increase sleep efficiency. Sleep training often includes establishing a consistent sleep schedule and creating a bedtime routine to signal the body that it is time to sleep. Understanding these mechanisms is crucial for patients because it empowers them to make lifestyle changes that can improve their sleep quality and overall health without relying solely on medication.

Effectiveness of Sequential Psychological and Medication Therapies for Insomnia Disorder: A Randomized Clinical Trial.Evidence to support treatment options for children with swallowing and feeding disorders: A systematic review.[Clinical efficacy of psychotherapy targeted for insomnia in comorbid depression].