Sleep Promotion Program for Teenagers with Sleep Disorders

(SPP PC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jessica C Levenson

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Disqualifiers: Sleep apnea, Narcolepsy, Bipolar, others

No Placebo Group

Trial Summary

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.

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}

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.

I am between 12 and 18 years old.

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.

Trial 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 (Behavioural Intervention)
• Sleep Psychoeducation (Behavioural Intervention)

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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Pittsburgh, PA

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1820

Patients Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3007

Patients Recruited

2,852,000+

Findings from Research

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]