Sleep Promotion Program for Teenagers with Sleep Disorders

(SPP PC Trial)

Overseen By Paige DeGennaro

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Sleep apnea, Narcolepsy, Bipolar, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have had changes in medications in the month before screening. This might mean that stable medication use is allowed.

What data supports the effectiveness of the Sleep Promotion Program, Sleep Psychoeducation treatment for teenagers with sleep disorders?

Research shows that sleep promotion programs can improve sleep quality, sleep onset, and reduce daytime sleepiness in adolescents. A study found that adolescents who participated in a sleep education program showed significant improvements in their sleep health knowledge and daytime functioning. ^{1 2 3 4 5}

Is the Sleep Promotion Program safe for teenagers?

The Sleep Promotion Program, also known as Sleep Psychoeducation, has been tested in studies with teenagers and has not shown any safety concerns. It focuses on improving sleep behaviors and has been used safely in various educational settings. ^{1 2 6 7 8}

How does the Sleep Promotion Program treatment differ from other treatments for sleep disorders in teenagers?

The Sleep Promotion Program is unique because it focuses on improving sleep behaviors through education and self-help strategies tailored to individual sleep patterns, rather than relying on medication or standard therapies like bright light therapy or melatonin. This program emphasizes teaching teenagers about proper sleep hygiene and encouraging them to adopt sleep-promoting behaviors, which can lead to better sleep quality and reduced daytime sleepiness. ^{1 2 9 10 11}

What is the purpose of this trial?

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on two individual sessions and smart phone technology to deliver evidence-based strategies. This R34 will test the feasibility and initial effectiveness of the SPP program and provider training via pilot randomized controlled trial (RCT, n=50) comparing SPP to Sleep Psychoeducation, a brief session on healthy sleep habits. Participants will be adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.

Research Team

Jessica C Levenson

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adolescents aged 12-18 who experience short sleep duration and irregular sleep-wake patterns, with symptoms of depression. The program aims to help them improve their sleep habits using smartphone technology and personal sessions.

Inclusion Criteria

I am over 18, a parent/guardian of a youth in the study, and spend 10+ hours weekly with them.

I am a minor and both I and my parent/guardian agree to participate.

Youth: Currently a patient at Kids Plus Pediatrics

Exclusion Criteria

I am young and have serious or uncontrolled health issues.

I am a young person diagnosed with a sleep disorder like sleep apnea or narcolepsy.

I am a young person needing urgent help for thoughts of harming myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Sleep Promotion Program (SPP) or Sleep Psychoeducation (SPE) over two individual sessions, approximately 2 weeks apart, with web-based intervention components.

4 weeks

2 visits (telehealth or in-person)

Follow-up

Participants are monitored for changes in sleep duration, sleep-wake regularity, and depressive symptoms.

8 weeks

Treatment Details

Interventions

• Sleep Promotion Program
• Sleep Psychoeducation

Trial Overview The study is testing a Sleep Promotion Program (SPP) that includes two individual sessions plus smart phone tech against just one session on healthy sleep habits. It's a small test run to see if the SPP can work in real life.

Participant Groups

Group I: Sleep Promotion Program Experimental Treatment 1 Intervention

Participants will receive the Sleep Promotion Program (SPP), consisting of 2 individual sessions with a clinician via telehealth (or in-person if desired), about 2 weeks apart, and web-based intervention components.

Group II: Sleep Psychoeducation Active Control 1 Intervention

Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A pilot trial involving 58 adolescents (average age 14) showed that a sleep promotion program significantly improved overall sleep quality, sleep onset latency, sleep duration, and reduced daytime sleepiness compared to a control group.

While the program demonstrated positive effects on sleep behaviors, it did not significantly impact sleep hygiene or other sleep parameters, indicating the need for further research to confirm its efficacy in a larger sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study. John, B., Bellipady, SS., Bhat, SU.[2020]

A sleep education program for adolescents significantly improved their knowledge of sleep health and promoted better sleep behaviors, as evidenced by substantial increases in sleep-related knowledge and practices after the intervention.

The program also led to notable improvements in sleeping patterns, including earlier bedtimes, reduced sleep-onset latency, increased total sleep time, and decreased daytime sleepiness, compared to a waiting-list control group of 243 students from 5 junior high schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a sleep education program with self-help treatment on sleeping patterns and daytime sleepiness in Japanese adolescents: A cluster randomized trial. Tamura, N., Tanaka, H.[2022]

In a long-term follow-up study of 10 adolescents with sleep-wake schedule disorders, 3 patients fully remitted and 6 showed improvement in their illness severity, indicating that intensive treatment can lead to positive outcomes over time.

All participants demonstrated enhanced social adaptation, suggesting that improvements in social functioning may be more pronounced than changes in the severity of the sleep disorders themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up study of 10 adolescent patients with sleep-wake schedule disorders. Ando, K., Hayakawa, T., Ohta, T., et al.[2019]

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]

School-based sleep promotion programs have the potential to significantly improve sleep knowledge, hygiene, quality, behavior, and efficiency among adolescents, who typically need 8 to 10 hours of sleep but often get less due to various pressures.

This systematic review will analyze studies involving adolescents aged 10-19, using rigorous methods to assess the effectiveness of these programs, which could lead to better sleep health and reduced risks of related issues like stress and cardiovascular problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of school-based sleep promotion programs for adolescents: a systematic review protocol. Duque, FM., Santos, D., Pinto, D., et al.[2023]

Involving stakeholders such as young adults, parents, and healthcare providers in the development of sleep promotion programs for adolescents is essential for creating effective and acceptable interventions, as highlighted by feedback from 9 focus groups with 49 participants.

Strategies to improve adolescent sleep should focus on enhancing internal motivation, personalizing content, and encouraging parents to model good sleep behaviors, which can help sustain behavior change and make programs more feasible and scalable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing adolescent sleep interventions with stakeholder input. Levenson, JC., Ford, HA., Reyes, ZMD., et al.[2022]

In a study of 54 adolescents with asthma, those who had only 6.5 hours of sleep per night experienced lower lung function and increased asthma symptoms compared to when they had 9.5 hours of sleep, highlighting the importance of adequate sleep for asthma management.

The findings suggest that insufficient sleep negatively affects both the physical symptoms of asthma and the overall quality of life for adolescents, indicating that improving sleep health should be a key focus in asthma treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of sleep opportunity on asthma outcomes in adolescents. Meltzer, LJ., Beebe, DW., Jump, S., et al.[2022]

The interactive school-based sleep education program (SEP) improved students' knowledge about sleep compared to a healthy living program, indicating that education can raise awareness about the importance of sleep.

Despite increased knowledge and intentions to prioritize sleep, the SEP did not lead to actual changes in sleep duration, suggesting that additional strategies, such as adjusting school start times and involving parents, may be necessary to effectively improve adolescent sleep habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial. van Rijn, E., Koh, SYJ., Ng, ASC., et al.[2020]

Sleep disorders affect about one-third of people and can lead to serious issues like depression and impaired performance in daily activities, especially during adolescence when conditions like delayed sleep phase syndrome (DSPS) become common.

Health professionals, including general practitioners and school nurses, need better training to identify and treat sleep disorders, as early recognition and appropriate referral to specialists can significantly improve outcomes for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disorders in general and in adolescence. Stores, G.[2015]

Adolescents generally need more sleep than they are getting, with many experiencing decreased total sleep time and increased daytime sleepiness due to factors like puberty, school schedules, and part-time jobs.

Chronic insufficient sleep in teenagers can lead to serious consequences, including mood and behavior problems, increased risk of accidents, and vulnerability to substance abuse, highlighting the need for educational programs on proper sleep hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of sleep and sleepiness in adolescents. Carskadon, MA.[2022]

Delayed sleep phase disorder (DSPD) is prevalent in adolescents and can lead to significant negative effects on academic performance, making accurate diagnosis crucial for effective treatment.

Treatment options for DSPD include bright light therapy, chronotherapy, and melatonin, which help regulate sleep patterns without acting as sedatives, alongside addressing lifestyle factors for improved sleep and mood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian rhythm disorders among adolescents: assessment and treatment options. Bartlett, DJ., Biggs, SN., Armstrong, SM.[2019]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Effects of a sleep education program with self-help treatment on sleeping patterns and daytime sleepiness in Japanese adolescents: A cluster randomized trial. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Long-term follow-up study of 10 adolescent patients with sleep-wake schedule disorders. [2019]

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

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

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

Effectiveness of school-based sleep promotion programs for adolescents: a systematic review protocol. [2023]

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

Designing adolescent sleep interventions with stakeholder input. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of sleep opportunity on asthma outcomes in adolescents. [2022]

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

Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Sleep disorders in general and in adolescence. [2015]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Patterns of sleep and sleepiness in adolescents. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Circadian rhythm disorders among adolescents: assessment and treatment options. [2019]