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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.

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 data supports the effectiveness of the Sleep Tight treatment for improving child sleep?

Research shows that behavioral interventions, like the Sleep Tight treatment, are effective in addressing sleep problems in children, with studies reporting success rates of up to 84% and long-lasting benefits. Additionally, a self-administered parenting intervention similar to Sleep Tight has been shown to improve children's sleep and increase parental confidence in managing sleep issues. ^{1 2 3 4 5}

How does the Sleep Tight treatment differ from other treatments for child sleep issues?

The Sleep Tight treatment is unique because it focuses on a parent-led intervention to improve child sleep, emphasizing education and routines rather than medication. This approach is similar to other family-centered interventions that aim to enhance sleep patterns through parental involvement and structured bedtime routines, which can also support broader developmental benefits. ^{1 5 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

A Randomized Trial of a Self-Administered Parenting Intervention for Infant and Toddler Insomnia. [2020]

2. Netherlands 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Behavioural management of sleep problems. [2019]

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

A systematic review of treatment of settling problems and night waking in young children [2019]

5. United States 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. [2019]

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

Changes in infant sleep problems after a family-centered intervention. [2015]

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

Evaluation of a sleep education program for low-income preschool children and their families. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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