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Behavioral Intervention

Sleep Intervention for Sleep

N/A

Recruiting

Research Sponsored by University of South Carolina

Eligibility Criteria Checklist

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

Must have

Have a child 2-4 years of age

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Study Summary

This trial was conducted to test a parenting program that aims to help improve the sleep of young children in low-income families. The families were divided into two groups - one received the intervention and the other was

Who is the study for?

This trial is for English-speaking parents or primary caregivers over 18 with a child aged 2-4 whose sleep doesn't meet age recommendations. They must have a low income (≤200% of Federal Poverty Line or on assistance like SNAP, WIC) and access to a computer or phone for video calls.Check my eligibility

What is being tested?

The study tests 'Sleep Tight,' an intervention aimed at improving children's sleep in low-income families. Participants are randomly placed into either the active intervention group or put on a wait-list as part of the control group.See study design

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a child between 2 and 4 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Intervention acceptability

Intervention feasibility: Enrollment yield for each recruitment strategy

Intervention feasibility: recruitment duration

+6 more

Secondary outcome measures

Child sleep: 24-hour sleep duration

Child sleep: daytime sleep duration

Child sleep: night sleep duration

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep InterventionExperimental Treatment1 Intervention

The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.

Group II: Comparison/controlActive Control1 Intervention

The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor

211 Previous Clinical Trials

120,399 Total Patients Enrolled

3 Trials studying Sleep

2,352 Patients Enrolled for Sleep

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

247,052 Total Patients Enrolled

4 Trials studying Sleep

196 Patients Enrolled for Sleep

Temple UniversityOTHER

297 Previous Clinical Trials

82,913 Total Patients Enrolled

5 Trials studying Sleep

685 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.

Which criteria must individuals meet in order to be considered eligible for participation in this trial?

"To be eligible for inclusion in this clinical trial, individuals should have a documented sleep disorder and fall between the ages of 2 and 4 years old. The study aims to recruit approximately 60 participants."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this ongoing trial is actively recruiting eligible participants. The study was initially posted for public viewing on January 8th, 2024 and has since been updated as recently as January 25th, 2024. A total of 60 individuals are sought after to participate in this trial across a single designated location."

Answered by AI

Is the inclusion criteria for this investigation allowing participants below the age of 40?

"Individuals between the ages of 2 and 4 are eligible for enrollment in this study."

Answered by AI

Are prospective patients still eligible to participate in this ongoing medical study?

"Indeed, as indicated on clinicaltrials.gov, this ongoing research study is actively seeking individuals to participate. The initial posting of the trial occurred on January 8th, 2024 and the most recent update was made on January 25th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Parent Intervention to Improve Child Sleep

Elizabeth Adams 2024. "Parent Intervention to Improve Child Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038591.