Sleep Promotion Program Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Pittsburgh
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to provide informed assent (with consent from parent/guardian)
Ages 12-18
Currently a patient at Kids Plus Pediatrics
Currently depressed
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SPP
BehavioralSPP prioritizes increasing sleep duration and regularizing sleep-wake timing. The provider and youth review the youth's sleep pattern, based on sleep diary data collected before and during the program and actigraphy data collected at baseline. They discuss benefits to the current sleep pattern, reasons for changing sleep, and they create an action plan. Psychoeducation about healthy sleep is offered via a handout developed by our group. Youth and provider jointly select SPP strategies relevant to the contributors to poor sleep for each youth (e.g., time management, limiting weekend oversleep). In the second session they review progress and adjust the plan. Parents participate for part of each session to learn about their child's sleep and to discuss ways they can support their child to make the planned changes.
Sleep Psychoeducation
BehavioralUsing the pamphlet also used in SPP, SPE will present sleep hygiene practices commonly included in sleep education programs and endorsed by national health organizations.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Sleep Promotion ProgramExperimental treatment 1 intervention
Group B: Sleep PsychoeducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Intervention Measure
The Feasibility of Intervention Measure (FIM) is a 4-item measure that assesses the feasibility of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.
Time frame
Post-Intervention (~8 weeks)2
Acceptability of Intervention Measure
The Acceptability of Intervention Measure (AIM) is a 4-item measure that assesses the acceptability of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.
Time frame
Post-Intervention (~8 weeks)3
Intervention Appropriateness Measure
The Intervention Appropriateness Measure (IAM) is a 4-item measure that assesses the appropriateness of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.
Time frame
Post-Intervention (~8 weeks)4
Clinical Global Impressions Scale - Improvement
This is a clinician rating of improvement in sleep and psychopathology. Clinicians rate domains of sleep health, psychiatric symptoms, and overall health on a range from 1 very much improved) to 7 (very much worse). A score of 0 indicates no assessment. Scores for each domain are reported individually.
Time frame
Post-Intervention (~8 weeks)Secondary outcomes
1
Pediatric Sleep Survey Sleep Knowledge (SK)
This is a provider self-report of knowledge about sleep. The sleep knowledge domain has 21 items that assess provider knowledge or sleep. The response options are true, false, or don't know. The number or percentage of correctly scored items is reported.
Time frame
Training Start to End of Study Involvement (Up to 2.5 years)2
SPP Therapy Rating Scale
This is a form completed by an independent rater who will review session recordings and rate them for fidelity. The scale has 5 items rated no (0) or yes (1), and 24 items rated 0 (not discussed/delivered) to 3 (excellent use of the skill). Items can be reported individually or can be summed to obtain a total score. Scale score range is 0 to 77
Time frame
Completed at each SPP Session (2 and 4 weeks after baseline)3
Sleep Diary Sleep Duration
This is a youth daily self-report of sleep, from which will be extracted sleep duration, reported in hours and minutes.
Time frame
Baseline to Post-Intervention (~8 weeks)4
Sleep Diary Sleep-Wake Regularity
This is a youth daily self-report of sleep, from which will be extracted sleep regularity, reported as difference in sleep-wake timing between weekdays and weekends.
Time frame
Baseline to Post-Intervention (~8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov