Sleep Promotion Intervention for Childhood Sleep Issues

Not yet recruiting at 1 trial location

Overseen By William P. Fifer, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cerebral palsy, Autism, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 3-week sleep program designed to improve sleep in young children. Researchers aim to assess the program's effectiveness and practicality by comparing children who participate with those who do not. The trial employs wearable technology to monitor sleep patterns in children aged 2-3 years in Dhaka, Bangladesh. Families with healthy children attending early learning centers and without serious health issues may qualify for this trial. As an unphased trial, it offers families the opportunity to contribute to research that could enhance sleep for young children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this behavioral sleep intervention is safe for children?

Research shows that the "Adapted Sleep Well, Bee Well" program has been tested in similar situations and has promising safety results. Earlier studies on the Sleep Well! program found that many families completed it and had positive experiences, with no major negative effects. Caregivers noticed significant improvements in their children's sleep and did not report any problems.

This program is behavioral, focusing on changing habits and routines instead of using medication. These methods are usually well-received by children because they don't involve drugs that might cause side effects.

While specific safety data from the current trial is not yet available, past studies suggest that similar programs have been safe and effective for improving sleep in young children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Promotion Intervention for childhood sleep issues because it focuses on a holistic approach involving both children and their parents. Unlike typical sleep treatments that might rely on medication or behavioral interventions aimed solely at children, this method engages parents through questionnaires and tailored guidance, emphasizing the role of family dynamics in improving sleep. The intervention is designed to be implemented in childcare centers over just three weeks, offering a practical and community-based solution that could lead to quicker improvements in sleep patterns compared to traditional methods.

What evidence suggests that this sleep intervention is effective for childhood sleep issues?

Research shows that programs to improve sleep habits can significantly help young children sleep better. For example, studies have found that the "Sleep Well, Bee Well" program reduces sleep problems as reported by caregivers. In one study, most families who completed the program noticed improvements in their child's sleep. Caregivers observed better sleep quality from before to after the program. This trial will test the adapted Sleep Well, Bee Well program to determine its effectiveness in enhancing sleep health in young children. Participants in the intervention arm will receive this program, while those in the control arm will not. ^{1 2 3 6 7}

Who Is on the Research Team?

Ayesha Sania, ScD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is healthy, aged 2-3, and goes to an early learning center.

Exclusion Criteria

My child has a heart condition.

My child has a significant developmental delay.

My child has autism and was born preterm or with low birthweight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data collection for both Control and Intervention Groups before the intervention starts

1 week

1 visit (in-person)

Intervention

3-week behavioral sleep intervention for the Intervention Group at the childcare center

3 weeks

Ongoing visits at childcare center

Post-Intervention Data Collection

Data collection for both groups following the completion of the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in sleep characteristics and parental knowledge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Sleep Well, Bee Well

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborator

Trials

315

Recruited

1,429,000+

Fogarty International Center of the National Institute of Health

Collaborator

Trials

157

Recruited

172,000+

Published Research Related to This Trial

Chronic sleep disruption in children and adolescents negatively impacts cognitive functioning, highlighting the importance of addressing sleep issues early.

Behavioral interventions, such as graduated extinction and positive bedtime routines, have been shown to significantly improve sleep problems in young children, making them effective nonpharmacological treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and treatment of common pediatric sleep disorders. Moturi, S., Avis, K.[2021]

A survey of 218 families revealed a high prevalence of sleep problems in children, with 85% of children aged 5-12 experiencing difficulties, highlighting the need for effective treatment options.

In a pilot study involving 11 families, a digital intervention using CBT-focused strategies led to significant improvements in sleep behaviors, including a 75.6% reduction in time awake and an increase of over 1 hour in total sleep time, demonstrating the effectiveness of digital sleep solutions for pediatric sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital solutions for sleep problems in children: A pilot study. Tedford, SE., Romano, L., Gozal, D., et al.[2022]

The TranS-C intervention led to moderate to large improvements in sleep quality and mental health symptoms among 14 adolescents with ADHD, with significant reductions in the percentage of poor sleepers from 71.4% pre-treatment to 21.4% post-treatment.

Improvements in sleep and executive functioning were generally maintained at a 3-month follow-up, suggesting that the intervention has lasting benefits, although further research through a randomized controlled trial is necessary to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial. Becker, SP., Duraccio, KM., Sidol, CA., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8974371/

Sleep Well! An adapted behavioral sleep intervention ...

Empirical reviews show that behavioral sleep interventions significantly improve early childhood sleep, including caregiver-perceived child sleep problems and ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34910624/

Sleep Well! An adapted behavioral sleep intervention ...

Results: Thirteen (86.6%) families completed Sleep Well! and 12 (80.0%) completed pre- and postintervention measures. Caregivers reported strong ...

3.

researchgate.net

researchgate.net/publication/357094622_Sleep_Well_An_adapted_behavioral_sleep_intervention_implemented_in_urban_primary_care

Sleep Well! An adapted behavioral sleep intervention ...

Caregivers also reported on child sleep pre- and post-intervention. Results: Thirteen (86.6%) families completed Sleep Well! and 12 (80.0%) completed pre- and ...

4.

researchgate.net

researchgate.net/publication/258115526_Sleep_well_-_Be_well_study_Improving_school_transition_by_improving_child_sleep_A_translational_randomised_trial

Sleep well - Be well study: Improving school transition by ...

This trial will determine whether the same intervention is beneficial and cost-effective when delivered by an existing school-based health ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1750946720301896

Research in Autism Spectrum Disorders

94% with Moderate/Severe sleep problems per parents had severe sleep problems per CSDI. However, 15% of those whose parents rated as None had a severe sleep ...

6.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT04536766

Impact of Bed Provision and Sleep Education | ...

Children and their caregivers will report on child sleep disturbance and sleep-related impairments, using the reliable and valid Patient-Reported Outcomes ...

7.

emedicine.medscape.com

emedicine.medscape.com/article/916611-treatment

Pediatric Sleep Disorders Treatment & Management

This section primarily reviews forms of cognitive-behavioral therapy (CBT) that are effective in treating a broad range of childhood behavioral sleep problems.