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Sleep Well! for Sleep

N/A

Waitlist Available

Led By Ariel Williamson, PhD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months (study duration)

Awards & highlights

Study Summary

This trial will test a sleep intervention to see if it's feasible and acceptable to families. It will also examine whether the intervention improves child sleep and behavior.

Eligible Conditions

Sleep
Sleep Disorder
Sleep Deprivation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months (study duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months (study duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months (study duration) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment Process

Family Engagement and Adherence

Retention Rate

+1 more

Secondary outcome measures

Child Behavior Problems

Child Sleep Patterns

Child Sleep Problems

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sleep Well! InterventionExperimental Treatment1 Intervention

Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary.

Group II: Enhanced Usual CareExperimental Treatment1 Intervention

The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Well!

2020

N/A

~120

Sleep education

2020

N/A

~130

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

707 Previous Clinical Trials

8,581,187 Total Patients Enrolled

5 Trials studying Sleep

216 Patients Enrolled for Sleep

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,637 Total Patients Enrolled

7 Trials studying Sleep

1,323 Patients Enrolled for Sleep

Ariel Williamson, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia

2 Previous Clinical Trials

48 Total Patients Enrolled

2 Trials studying Sleep

48 Patients Enrolled for Sleep

Frequently Asked Questions

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

What is the current participant count of this research project?

"Indeed, the information hosted on clinicaltrials.gov affirms that this research is actively recruiting participants. The trial was made public on October 16th 2020 and its details have recently been revised as of June 1st 2022. A total of 120 individuals need to be recruited at a single medical facility for successful execution of this experiment."

Answered by AI

Are there any openings available for enrollees in this research trial?

"This clinical trial, which was initially announced on October 16th 2020, is still recruiting participants according to the information hosted by clinicaltrials.gov. The most recent modifications were made on June 1st 2022."

Answered by AI

Who meets the criteria for admission to this clinical investigation?

"To be eligible for participation in this medical study, patients must suffer from sleep debt and fall between the ages of 1 Year and 5. Currently, there is a quota of 120 people to fill."

Answered by AI