RightFit
RecruitingNot applicable

Sleep Promotion Program Primary Care

A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a brief sleep program for teens ages 12–18 who have depression and sleep too little or at irregular times. The program uses two one-on-one sessions and smartphone tools. Researchers will compare it with a short lesson on healthy sleep habits to see how well it works and whether the program and staff training are practical.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Teens must be ages 12–18.
  • Teens must agree to join, with permission from a parent or guardian.
  • Teens must be current patients at Kids Plus Pediatrics.
  • Teens must currently have depression.
  • Teens must sleep less than 7 hours on school nights, have sleep times that differ by at least 2 hours between weekdays and weekends, or both.
  • Parents or guardians must be at least 18 and have a teen enrolled in the study.
  • Parents or guardians must spend at least 10 hours a week face-to-face with the teen.

Who can't join

  • Teens cannot have a serious or unstable medical condition.
  • Teens cannot have diagnosed sleep apnea (breathing pauses in sleep), narcolepsy (sudden sleep attacks), restless legs syndrome (an urge to move the legs), nightmare disorder, or periodic limb movement disorder (repeated limb movements in sleep).
  • Teens cannot have PTSD (stress after trauma), bipolar disorder (extreme mood swings), a psychotic disorder (trouble knowing what is real), or a substance use disorder (harmful drug or alcohol use).
  • Teens cannot be in therapy aimed at changing thoughts or habits to improve sleep.
  • Teens cannot have had medication changes in the month before screening.
  • Teens and parents cannot have current suicidal thoughts or actions that need immediate treatment.
  • Teens and parents cannot have a physical or mental condition that prevents them from taking part.
  • Teens and parents must be able and willing to follow the study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Youth: * Able and willing to provide informed assent (with consent from parent/guardian) * Ages 12-18 * Currently a patient at Kids Plus Pediatrics * Currently depressed * Report short sleep duration (\<7 hours on school nights) and/or weekday-weekend sleep timing difference of \>=2 hours Parents: Parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week. Exclusion Criteria: Youth: * Significant or unstable medical conditions * Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder * Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder * Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep * Changes in medications in the month prior to screening * Active suicidality requiring immediate treatment * Unable or unwilling to comply with study procedures * Have any physical or mental condition that would preclude study participation. Parents will be excluded if they: * Express active suicidality that requires immediate treatment; * Have any physical or mental condition that would preclude study participation; OR * Are unable or unwilling to comply with study procedures.

Study sites (1)

PA