Sleep Promotion Intervention for Childhood Sleep Issues

N/A

Waitlist Available

Led By Ayesha Sania, ScD

Research Sponsored by Columbia University

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 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a 3-week behavior sleep intervention for 2-3 year old children in Bangladesh to improve their sleep health.

Who is the study for?

This trial is for healthy children aged 2-3 years who attend early learning centers. It's not suitable for kids with cerebral palsy, severe developmental delays, cardiac disease, autism or those born preterm or with low birthweight.

What is being tested?

The study tests a behavioral sleep intervention called 'Adapted Sleep Well, Bee Well' over three weeks to see if it helps improve sleep in preschoolers compared to children who are on a wait-list at two Early Learning Centers in Dhaka, Bangladesh.

What are the potential side effects?

Since this is a behavioral intervention focusing on improving sleep habits and routines without the use of medication, no direct side effects are anticipated as part of the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days 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 Parental knowledge and beliefs about children's sleep

Intervention feasibility and acceptability

Secondary study objectives

Change in Bedtime Routine

Change in Bedtime Variability

Change in Children's Sleep Duration Variability

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Parent questionnaires and sleep characteristics of children (actigraphy and parent report) will be collected at three-time points- Time 1, 2, and 3. Time 1 is the first Baseline Data Collection for the Control Group and Intervention Group, and these data will be collected before the intervention group starts the 3-week intervention. Between Time 1 and Time 2, the Intervention Group will receive the 3-week intervention at the childcare center.

Group II: ControlActive Control1 Intervention

The control arm will not receive the intervention. They will be assessed at time 1 and again at 2, following the completion of intervention in the intervention arm

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