Sleep Tight Program for Child Sleep

Overseen By Ellen Siceloff, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Medical condition, Clinical sleep disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help parents improve their young children's sleep. The program, called Sleep Tight, guides parents in creating soothing bedtime routines and managing bedtime resistance and nighttime wakings to boost overall sleep quality. It seeks parents or caregivers with children aged 2-4 who aren't getting enough sleep and have a household income at or below 200% of the Federal Poverty Line. Participants need access to a computer or phone for video calls. Families will receive the sleep program either immediately or after a waiting period.

As an unphased trial, this study offers families the opportunity to access potentially helpful sleep strategies tailored for young children.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if your child takes medication that significantly impacts their sleep, they may not be eligible to participate.

What prior data suggests that the Sleep Tight Intervention is safe for children?

Research has shown that behavioral sleep methods for children are generally safe and well-tolerated. For example, studies have explored ways to improve children's sleep, such as creating calming bedtime routines and managing nighttime awakenings, without causing harm.

One study on sleep health education programs for kids found no serious side effects. This finding suggests that teaching parents sleep strategies and working on sleep routines is likely safe.

While not all methods are identical, previous research has considered behavioral strategies for sleep as safe. There might be minor challenges, like adjusting to new routines, but overall, these methods are seen as a safe way to improve sleep in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Sleep Tight program is unique because it focuses directly on empowering parents with behavioral strategies to improve their child's sleep, unlike traditional methods that might rely on medication or passive monitoring devices. Researchers are excited about this approach because it emphasizes creating consistent bedtime routines and managing behaviors that disrupt sleep, potentially offering a more sustainable and holistic solution for sleep issues in young children. By involving parents actively, the program aims to foster long-term healthy sleep habits, which could lead to more lasting improvements than current options.

What evidence suggests that the Sleep Tight intervention is effective for improving child sleep?

This trial will evaluate the Sleep Tight intervention, which aims to enhance young children's sleep by providing parents with behavioral strategies and support. Research has shown that helping children develop good sleep habits can significantly improve their sleep. Studies have found that methods like setting a regular bedtime routine and managing bedtime struggles can reduce nighttime awakenings. For example, a review of several studies found that these methods lead to better sleep and are effective for children from diverse backgrounds. A regular bedtime routine is also linked to improved emotional and behavioral control in children. Overall, these approaches not only improve sleep but also support a child's growth and well-being. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can speak English.

I have a child between 2 and 4 years old.

The child's duration of sleep does not accord with the accepted standards for that age.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents receive virtual sessions with an interventionist focusing on enhancing children's sleep through behavioral strategies and support.

6 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for changes in child sleep patterns and other health behaviors post-intervention.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Tight

Trial Overview 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.

How Is the Trial Designed?

Group I: Sleep Intervention Experimental Treatment 1 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/control Active Control 1 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.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Published Research Related to This Trial

A single 45-minute educational session for parents significantly improved sleep outcomes in 26 school-aged children with neurodevelopmental or mental health disorders, leading to reduced insomnia and daytime sleepiness scores after 3 months.

The intervention also resulted in increased sleep duration on both weekdays and weekends, highlighting its effectiveness as a low-cost, entry-level treatment in a stepped-care approach for addressing sleep issues in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led brief sleep education intervention aimed at parents of school-aged children with neurodevelopmental and mental health disorders: Results from a pilot study. Bastida-Pozuelo, MF., Sánchez-Ortuño, MM., Meltzer, LJ.[2019]

A family-centered intervention for sleep-disturbed infants, involving education for parents and support for infants' self-comforting, significantly improved night sleep patterns within one week of discharge from the hospital.

The positive effects on sleep continued to enhance over a two-month period, indicating the long-term efficacy of the intervention for infants aged 6-23 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in infant sleep problems after a family-centered intervention. Skuladottir, A., Thome, M.[2015]

A sleep education program for low-income preschool families significantly improved parents' knowledge, attitudes, and self-efficacy regarding sleep, although these gains were not maintained after one month.

Children in the intervention group experienced a notable increase in weeknight sleep duration by 30 minutes after one month, highlighting the program's positive impact on children's sleep behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a sleep education program for low-income preschool children and their families. Wilson, KE., Miller, AL., Bonuck, K., et al.[2021]

A study of 19 children with sleep disorders showed an impressive 84% success rate using behavioral management techniques, which was sustained at a 6-month follow-up.

Successful treatment outcomes were linked to factors such as the absence of marital discord and the involvement of both parents in the treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural management of sleep problems. Jones, DP., Verduyn, CM.[2019]

The Better Nights, Better Days (BNBD) program, an online intervention for treating insomnia in children aged 1-10, was tailored to address insomnia symptoms that persist after surgical treatment for obstructive sleep apnea (OSA).

Usability testing with 43 participants, including parents and healthcare providers, indicated that the new session was generally viewed as helpful, suggesting that further testing on a larger scale could enhance its effectiveness for children experiencing insomnia post-OSA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A usability study of an internet-delivered behavioural intervention tailored for children with residual insomnia symptoms after obstructive sleep apnea treatment. Orr, M., Isaacs, J., Godbout, R., et al.[2023]

Establishing a nightly bedtime routine is crucial for promoting healthy sleep and overall development in young children, especially those at risk, as it incorporates nurturing care and early stimulation.

Components of a bedtime routine, such as reading, hygiene practices, and physical contact, not only improve sleep but also enhance language development, emotional regulation, and parent-child bonding, making it a cost-effective strategy for supporting child development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of a bedtime routine in young children: Sleep, development, and beyond. Mindell, JA., Williamson, AA.[2023]

Drug treatments can effectively reduce night waking in young children in the short term, but their long-term effectiveness is uncertain.

Behavioral interventions not only show immediate benefits for settling problems and night waking but also suggest potential long-term improvements, making them a more appealing option for lasting solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of treatment of settling problems and night waking in young children Ramchandani, P., Webb, V., Stores, G.[2019]

In a study involving 239 families, a self-administered DVD intervention called the Sleep Easy Solution significantly improved perceptions of children's sleep problems compared to a wait-list group, indicating its efficacy in addressing pediatric sleep issues.

The DVD intervention also led to longer continuous sleep periods and increased parental confidence in managing their child's sleep, suggesting it is a valuable tool for families facing sleep challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of a Self-Administered Parenting Intervention for Infant and Toddler Insomnia. Stevens, J., Splaingard, D., Webster-Cheng, S., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11098045/

Child routines moderate a brief behavioral intervention to ... Emerging evidence suggests that behavioral sleep interventions may also be effective in improving sleep in typically developing school-aged children (Hart et al ...

2. nature.com nature.com/articles/s41598-022-07762-8

Effectiveness of behavioral sleep interventions on ... This systematic review and meta-analysis was conducted to investigate the effectiveness of behavioral sleep interventions (BSIs) on the number of child night ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0163638325000013

Early bedtime routines and behavioral outcomes among ... Consistent early bedtime routine helps children to regulate their emerging emotions which in turn has long-term benefits on their emotional and behavioral ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6587181/

Benefits of a bedtime routine in young children A nightly bedtime routine as a key factor in the promotion of not only healthy sleep, but also of broad development and wellbeing in early childhood.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9822

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12483301/

The Power of Pediatric Sleep: Shaping Healthy Evidence‐ ... Pediatric sleep is a crucial but often overlooked component of child health, influencing development, well‐being, and long‐term outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8762353/

Interventions to Improve Safer Sleep Practices in Families ... Interventions include safe sleep space programs, intensive home visits, peer educators, and health education, to improve safer sleep practices.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0145213424004733

Initial efficacy of a trauma-informed sleep intervention for ... Findings suggest SAFE-T to be a promising intervention for improving sleep health among children currently or previously placed in foster care.

9. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8488

Behavioral interventions for infant sleep problems: the role of ... This study showed that parental cry tolerance and sleep-related cognitions predict treatment outcomes, with greater improvement in parent-reported sleep for ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794639

Effects of a Sleep Health Education Program for Children ... This stepped-wedge cluster randomized clinical trial evaluates the effects of a Head Start sleep health literacy program on sleep duration ...