Sleep Promotion Intervention for Childhood Sleep Issues

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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Adapted Sleep Well, Bee Well for childhood sleep issues?

Research shows that establishing regular bedtime routines can help reduce night awakenings and increase sleep duration in children, which suggests that structured sleep interventions like Adapted Sleep Well, Bee Well may be effective for improving sleep in children. ^{1 2 3 4 5}

Is the Sleep Promotion Intervention for Childhood Sleep Issues safe for children?

The Sleep Well! intervention, which is similar to the Sleep Promotion Intervention, has been studied in urban primary care settings and is designed for children with insomnia and insufficient sleep. While specific safety data is not detailed, behavioral sleep interventions like this are generally considered safe for children. ^{3 4 6 7 8}

How is the Adapted Sleep Well, Bee Well treatment different from other treatments for childhood sleep issues?

The Adapted Sleep Well, Bee Well treatment is unique because it uses a digital platform to deliver cognitive behavioral therapy (CBT) strategies specifically designed for children with sleep issues, making it accessible and tailored to individual needs over a 6-10 week period. ^{3 6 9 10 11}

What is the purpose of this trial?

Using a pragmatic cluster randomized trial, this study aims to examine the feasibility and acceptability of a 3-week behavioral sleep intervention and to test the preliminary efficacy of the intervention compared to a wait-list control with children ages 2-3 years old at two Early Learning Centers on preschooler's sleep health in Dhaka, Bangladesh. The investigators will use novel, inexpensive wearable technology to measure sleep health of children at ages 2, 3, and 4 years in a total of 60 families of 2-3 year-old healthy children and teachers from both childcare centers. The program teaches early childhood educators about healthy sleep for young children and will train them to be confident facilitators of educational conversations about sleep with parents. 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 either 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. Time 2 data collection for both groups will occur during the week following the completion of the intervention received by the Intervention Group. Time 2 data will serve as post-intervention data for the Intervention Group.

Research Team

Ayesha Sania, ScD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bedtime routines in early childhood: prevalence, consistency, and associations with nighttime sleep. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Parental and self-report of sleep in children with attention-deficit/hyperactivity disorder. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An Intervention to Promote Sleep and Reduce ADHD Symptoms. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Sleep Onset and Night Waking Insomnias in Preschoolers with Psychiatric Disorders. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Correlates of nocturnal sleep duration, nocturnal sleep variability, and nocturnal sleep problems in toddlers: results from the GET UP! Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Sleep Well! An adapted behavioral sleep intervention implemented in urban primary care. [2023]

7. Poland pubmed.ncbi.nlm.nih.gov

Treatment of behavioral sleep problems in children and adolescents - literature review. [2018]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Assessment and treatment of common pediatric sleep disorders. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacologic treatments for pediatric sleeplessness. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Digital solutions for sleep problems in children: A pilot study. [2022]