An interventional study of Better Nights, Better Days for Youth in Rheumatic Diseases, Arthritis and Lupus, sponsored by The Hospital for Sick Children. Not yet recruiting. Open to female participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Supportive care
Among 11 studies in Arthritis, Juvenile by The Hospital for Sick Children — 3 open to participants now, 3 under way, none of them phase 3. Arthritis, Juvenile · The Hospital for Sick Children.
Among the 11 studies in Arthritis, Juvenile by The Hospital for Sick Children, this one is the 8th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2026, is one of 9 with no phase, and was the 11th registered.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 43 is below the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →3 of the 11 studies in Arthritis, Juvenile by The Hospital for Sick Children are open now, in 2 countries. Each count lists the studies.
Of the 69 Arthritis, Juvenile studies recruiting now, 13 (19%) set no upper age limit and 50 (72%) stop at 75 or younger; 65 take children under 18; 11 take healthy volunteers.
This study: 12 Years to 18 Years · female · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2026.
Median enrollment 57 across the 10 interventional studies, 4,100 across the 1 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Arthritis, Juvenile by The Hospital for Sick Children, from their registry updates:
Nothing recorded among them since 2026-09-25.
Overall, our understanding of how pain and sleep are experienced and how they can be treated in teenagers with rheumatic diseases is limited. This two-phased study aims to deepen our understanding of pain and sleep in this population using 'Better Nights, Better Days for Youth' (BNBD-Youth). 'BNBD-Youth' is a self-guided web-based sleep program for teenagers with sleep problems that uses educational and behavioural strategies, such as understanding sleep processes and changing unhelpful thoughts about sleep, to help improve sleep experiences. In Phase One, participants will use daily diaries to record their sleep and pain, and then use 'BNBDYouth' for five weeks to test whether it improves these outcomes. Then, in Phase Two, these participants will take part in an interview to further describe their experiences using 'BNBD-Youth' and their pain and sleep.
Across two phases, this research will use an explanatory sequential mixed methods design involving (1) a single-arm trial of Better Nights, Better Days for Youth (BNBD-Youth) with 30 adolescents, aged 12-18, with a chronic pediatric rheumatic disease to characterize the correlational pain-sleep relationship and to estimate the preliminary effectiveness of the web-based sleep program on sleep and pain outcomes. These quantitative findings will guide the selection of participants, and the interview questions asked in the (2) subsequent qualitative study involving individual, semi-structured interviews with 10-26 quantitative participants to further contextualize the pain-sleep relationship using the personal pain and sleep experiences reported by participants. The quantitative and qualitative datasets will be analyzed separately and then merged during the interpretation phase.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 43 is below the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Compared within Arthritis, Juvenile, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Rheumatic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Better Nights, Better Days for Youth
BNBD-Youth is a web-based sleep program, available only for research, designed to introduce healthy sleep practices to adolescents and young adults with sleep disturbances, aiming to improve their sleep quality and duration. It is entirely self-guided and adolescent-based (i.e., does not involve the caregiver or healthcare professional) and accessed on the individual's personal device (e.g., smartphone, tablet, computer). This program comprises 31 short, interactive microlessons organized into 4 overarching sessions.
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item, validated self-report questionnaire that assesses the nature, severity, and impact of sleep over the past 2 weeks, with a total score ranging from 0-28. It has an acceptable internal consistency (Cronbach's α = 0.74) and is selected as Phase One's primary outcome because it is: 1. Frequently used in sleep research with older children, 2. Brief and easy to complete, and 3. Sensitive to perceived sleep impact after treatment.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
PROMIS Pediatric Pain Interference - Short Form 8a
The PROMIS Pediatric Pain Interference - Short Form 8a is an 8-item self-report tool that assesses the impact of pain on function over the past seven days. It has high internal consistency in children, 8-18 years old, with chronic pain (Cronbach's α = 0.90). PROMIS instruments are scored using item-level calibrations and response pattern scoring. PROMIS scores will be calculated via REDCap auto-score, guided by the HealthMeasures Scoring.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Pain Symptom Tracker
Daily pain will be collected via the "Check-in" feature on iCanCope, a smartphone-based pain self-management app developed through a phased, user-centred design study with adolescents with chronic pain and healthcare providers. Using numeric rating scales ranging from 0-10, the Check-in feature collects self-reported data on pain intensity, pain interference, mood, physical activity, sleep quality, and energy. The Check-in feature uses adolescent-friendly language, pictorial response options, and daily push notifications at a time of their choice to promote engagement. In previous iCanCope studies with adolescents (12 to 18 years) with chronic pain and JIA, over half of the participants were shown to have high to moderate levels of adherence to the application. Participants will be asked to complete three check-in entries each day. Each entry is estimated to take up to 1 minute to complete.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Sleep Diary
In sleep research, sleep diaries are considered the "golden standard" for subjective sleep assessment. This study will use an investigator-developed sleep diary on REDCap that participants will complete upon waking to capture participants' sleep patterns close to the time they occur, including sleep efficiency (i.e., the percentage of total time spent asleep while in bed), a composite of total sleep time and total time in bed, and sleep quality. The necessary fields selected to calculate these sleep parameters were selected based on (1) this study's research objectives and (2) a previous research consensus-based panel. Participants will be advised to complete 1 daily sleep diary entry shortly upon waking, reflecting the night before and the day of. Each diary entry is estimated to take up to 5 minutes to complete. Data entered by participants is automatically populated into REDCap.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Actigraphy
Objective sleep-wake activity will be captured using an actigraph wrist device (ActiGraph GT9X Link \[Ametris\] and Actiwatch 2 \[Philips Respironics\]), which measures movement using a 3-axis accelerometer to detect raw position and rotational data. In sleep research, actigraphy is preferred to polysomnography, the "golden standard" for objective sleep measurement, due to practicality reported by research participants. In this study, actigraph data is compared with sleep diary data to screen for potential artifacts.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Pediatric Anxiety - Short Form 8a
The PROMIS Pediatric Depressive Symptoms - Short Form 8a and PROMIS Pediatric Anxiety - Short Form 8a scales are 8-item tools that assess symptomology during the past seven days. PROMIS instruments are scored using item-level calibrations and response pattern scoring. PROMIS scores will be calculated via REDCap auto-score, guided by the HealthMeasures Scoring.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
PROMIS Pediatric Depressive Symptoms - Short Form 8a
The PROMIS Pediatric Depressive Symptoms - Short Form 8a and PROMIS Pediatric Anxiety - Short Form 8a scales are 8-item tools that assess symptomology during the past seven days. PROMIS instruments are scored using item-level calibrations and response pattern scoring. PROMIS scores will be calculated via REDCap auto-score, guided by the HealthMeasures Scoring.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Patient Global Assessment
The Patient Global Assessment is a 21-point visual analogue scale widely used in pediatric rheumatic diseases to allow patients to subjectively rate their disease status. The 21-point scale was selected over the traditional 10-cm horizontal line scale because evidence indicates it is more feasible and may increase the precision of patient assessment.
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales
The Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales is a 23-item self-report tool comprising 4 dimensions (i.e., physical, emotional, social, and school functioning) to determine HRQoL. The PedsQL has high internal consistency in children up to 18 years (Cronbach's α = 0.88).
Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)
Patient Global Impression of Change
The Patient Global Impression of Change is a single-item, self-reported 7-point rating of participants' perceived change at the end of the study. In pediatric chronic pain clinical trials, the PGIC is recommended for its clinical utility and ease of use.
Time frame: Immediately post-intervention (5 weeks post intervention-start)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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