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Choice may be key: could letting parents pick a coaching program help young kids sleep and behave better?

NCT ID NCT04824989

Disease control Sponsor: Boston University Charles River Campus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study tests whether giving low-income parents of toddlers with sleep and behavior problems a choice of coaching program leads to better outcomes than being assigned one. Families are randomly placed into one of four groups: sleep coaching, behavior coaching, a choice between the two, or an active control. Researchers will track child sleep, behavior, and family functioning over nine months to see if offering choice improves engagement and results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Parent coaching interventions: sleep-focused (SHIP), behavior-focused, family choice, and active control
What this could lead to
If giving families a choice boosts engagement, it could make early interventions more effective for low-income children, reducing health disparities.
What could go wrong
The trial is relatively small and relies on parent reports, which may not reflect real-world effectiveness. Results may not generalize beyond this population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

305 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 48 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Child Behavior Parasomnias psychiatric disorder sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Behavior, child Sleep problem

Contacts and locations

Locations

  • Boston University

    Boston, Massachusetts, 02215, United States

  • University of Denver

    Denver, Colorado, 80208, United States

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