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Behavioural Intervention

Sleep Promotion Program for Sleep Disorder (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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SPP PC Trial 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.Check my eligibility

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.See study design

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.

SPP PC Trial 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.

SPP PC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Intervention Measure

Clinical Global Impressions Scale - Improvement

Feasibility of Intervention Measure

+2 more

Secondary outcome measures

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

SPP PC 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,592 Total Patients Enrolled

University of PittsburghLead Sponsor

1,725 Previous Clinical Trials

16,305,701 Total Patients Enrolled

Jessica C LevensonPrincipal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently accepting new participants?

"As per clinicaltrials.gov, the current status of this research is not open for recruitment. The trial information was initially shared on July 1st, 2024 and most recently revised on February 1st, 2024. Although this specific study is not actively seeking participants currently, there are approximately 275 other trials available for patient enrollment."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"The primary focus of this investigation, to be evaluated within an approximately 8-week period post-intervention, is the Intervention Appropriateness Measure. Secondary assessments encompass the SPP Therapy Rating Scale - a tool completed by an impartial evaluator who reviews session recordings and rates fidelity on a scale from 0 (not discussed/delivered) to 3 (excellent skill use), yielding a total score range of 0-77; Pediatric Sleep Survey Sleep Knowledge (SK) gauges provider sleep knowledge based on responses of true, false or unknown across 21 items; and Sleep Diary Sleep Duration where youth self-report their daily sleep hours in intervals"

Answered by AI

Does this medical study have eligibility criteria that include individuals above the age of 60?

"Prospective participants must be between 12 and 18 years old to qualify for enrollment in this clinical trial."

Answered by AI

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"In order to be eligible for this research, candidates must exhibit symptoms of a sleep disturbance and fall within the age bracket of 12 to 18 years. The investigation aims to enroll approximately 100 adolescent participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Promotion Program Primary Care

Jessica Levenson 2024. "Sleep Promotion Program Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06240325.

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