TS-C-STEP
BehavioralCognitive behavioral sleep intervention.
NCT Number: NCT07213908
The goal of this clinical trial is to conduct a comparative effectiveness trial that will evaluate two school-based interventions to improve adolescent sleep health: the standard Sleep Health Education (SHE) and a stepped care version of the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP). The main questions it aims to answer [is/are]:
* TS-C-STEP will yield superior outcomes relative to SHE at post-treatment and up to 12 months following treatment. * In this large and diverse sample, vulnerable subgroups (e.g. socioeconomically disadvantaged, racial, ethnic, rural, and youth with comorbid learning and/or mental health conditions) will experience greater benefits from TS-C-STEP compared to SHE on primary and secondary outcomes.
Researchers will compare sleep quality to determine which intervention is most effective.
Interested in participating?
Request Info12 year–18 year
All sexes
Interventional
Not applicable
Children's Hospital Los Angeles, Los Angeles, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive behavioral sleep intervention.
Health Education
Time frame: Baseline to 14 months
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores yields one global score with a minimum score of 0 and a maximum score of 21. A higher score indicates more self-reported sleep problems.
Time frame: Baseline to 14 months
7-item scale assessing the perceived severity of insomnia symptoms. The sum of scores yields a total score with a minimum score of 0 and a maximum score of 28. A higher score indicates more severe insomnia symptoms.
Time frame: Baseline to 14 months
Evening Circadian Preference is a reliable and valid 10-item measure of circadian preference among youth
Time frame: Baseline to 14 months
PROMIS is a well-validated 8-item measure which assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. A total raw score can range from 8 to 40, with a higher score indicating more sleep related impairment.
Time frame: Baseline to 14 months
Sleep diary asks participants about daily morning estimates of sleep the night prior parameters yield a reliable and valid clinical index of self-reported sleep duration.
Time frame: Baseline to 14 months
The PROMIS Scale Global Health is a ten-item patient reported measure of physical, mental and social health.
Time frame: Baseline to 14 months
Academic Functioning Youth participants will be asked to provider their official academic transcripts.
Time frame: Baseline to 14 months
Youth Self-Report (YSR) is a widely used self-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 224 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample.
Time frame: Baseline to 14 months
Child Behavior Checklist (CBCL) completed by parents is a widely used child-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 198 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample.
Contact information is provided by the study sponsor or research team.
Children's Hospital Los Angeles
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01778504
Autism Spectrum Disorder, Autistic Disorder
Bethesda, Maryland, United States
View Trial DetailsNCT07489417
Blood Pressure, Sleep
Columbia, Missouri, United States
View Trial DetailsNCT07729930
Arthralgia, Blood Pressure and Augmentation Index
Loughborough, United Kingdom
View Trial DetailsNCT07411222
Behavior, Bipolar Disorder
Bolu, Turkey (Türkiye)
View Trial Details