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Behavioural Intervention

Sleep Promotion Program for Teenagers with Sleep Disorders (SPP PC Trial)

N/A

Waitlist Available

Led By Jessica C Levenson

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Youth: Ages 12-18

Youth: Currently depressed

Must not have

Youth: Significant or unstable medical conditions

Youth: Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up training start to end of study involvement (up to 2.5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new program called the Sleep Promotion Program for teenagers who don't sleep enough and have irregular sleep patterns. The program involves two sessions and uses smartphone technology to provide helpful strategies. The

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves behavioral interventions and education rather than medication, side effects are minimal but may include potential stress or anxiety from changes in routine or frustration with adherence to the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 18 years old.

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I am currently experiencing depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am young and have serious or uncontrolled health issues.

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I am a young person diagnosed with PTSD, bipolar, psychosis, or substance use disorder.

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

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

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I am a parent experiencing thoughts of suicide that need urgent care.

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I am unable or unwilling to follow the study's required procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ training start to end of study involvement (up to 2.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~training start to end of study involvement (up to 2.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and training start to end of study involvement (up to 2.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure

Clinical Global Impressions Scale - Improvement

Feasibility of Intervention Measure

+2 more

Secondary study objectives

Pediatric Sleep Survey PC

Pediatric Sleep Survey Sleep Knowledge (SK)

Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep Promotion ProgramExperimental Treatment1 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 PsychoeducationActive Control1 Intervention

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

0 / 8Eligibility criteria met