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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR017471-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Sleep deficiency is a public health concern in children with a chronic illness such as Juvenile Idiopathic Arthritis (JIA) because it is often overlooked in clinical care, attributed to the underlying chronic illness, and contributes to poor health outcomes. Development of an effective technology-based sleep shared-management intervention that integrate children and parents in the co-design and development of the intervention has the potential to improve health outcomes of children living with JIA and their parents.
To develop and test a technology-based sleep shared-management intervention delivered to 8-to-13 year-old children with JIA and their parents. The initial feasibility, acceptability, and efficacy of the newly developed sleep shared-management intervention will be tested in a pilot randomized controlled trial comparing the active intervention against standard care with a sample of 60 children with JIA and their parents. Sleep will be measured using actigraphy, sleep diaries, & self-report measures. Self-efficacy will be measured before and after the intervention. The long-term goal is to develop effective and low cost treatments to reduce sleep deficiency and the sleep-related health consequences among children with JIA. The specific aims are to:
Aim 1. Apply a human-centered design approach to develop and refine a technology-based sleep shared-management intervention (SLEEPSMART). Direct stakeholder input will be obtained from children and parents about their needs for sleep shared-management as well as intervention material adapted from the Transdiagnostic Sleep-Circadian Dysfunction program for youth that includes four cross cutting components (sleep complaint, education, behavior change and motivation, and goal setting) across the modules and a shared- management focus (motivation, self-efficacy) with children and parent partnering together to improve sleep. Qualitative methods (iterative cycles of semi-structured audiotaped sessions with children and parents and think-aloud observation sessions by a trained observer) will be used to evaluate the usability of the SLEEPSMART prototype. Results of these analyses will guide program finalization.
Aim 2. Determine feasibility and initial efficacy of the SLEEPSMART with children with JIA in a pilot RCT. Study accrual and dropout rates will be assessed, as well as, levels of patient acceptability and engagement in a pilot randomized controlled trial (RCT) comparing usual care to SLEEPSMART intervention. Preliminary effect sizes of the SLEEPSMART will be determined in youth receiving treatment compared to usual care on primary outcomes of actigraphy sleep duration, self-report sleep disturbances, and feasibility/acceptability, and secondary outcomes include self-efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLEEPSMART PROGRAM | Experimental | Arm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. Arm: Experimental -Each child and parent dyad will work together to create sleep goals, problem solve and compromise to accomplish the goals, and interact with fields in the Web site. The modules will focus on learning a wind-down and wake-up routine, reducing time in bed, reducing sleep-related worry, negotiating sleep in the environment, correcting unhelpful sleep-related beliefs, and sleep maintenance and relapse prevention. The intervention will last 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLEEPSAMRT | Behavioral | SLEEPSMART is a web-based intervention that adapted and modified components from the Transdiagnostic Sleep and Circadian intervention for youth and included four cross-cutting components (sleep complaint, education, behavior change and motivation, and goal-setting) that were integrated into each module. To begin the intervention, participants were provided a link to the SLEEPSMART intervention website for one of the above modules and an online sleep coach each week. At the end of each week, children and parents uploaded the weekly activities and goals via the REDCap link and set up a meeting with the sleep coach to review. The modules took 20 to 30 minutes to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbance | PROMIS Sleep Disturbance an 8-item questionnaire that measures self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Items are rated on a 5-point Likert scale (1= not at all/very poor, 2 = a little bit/poor, 3=somewhat/fair, 4=quite a bit/good, 5= very much/very good). The raw scores are converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores suggest more disturbed sleep. | Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion) |
| Sleep Efficiency | Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep. | Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion) |
| Sleep Duration | Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period; | baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) |
| Acceptability of SLEEPSMART | Parent and child survey about the likes and dislikes of the study protocol, areas for improvement, SLEEPSMART program and weekly assignments. Items are scored using a 5-point scale, with 1 equalling strongly disagree and 5 equalling strongly agree. Scores can range from 9 to 45 with higher scores representing greater acceptance. A total score of moderate acceptability for the nine items would be 27. | 3 months at study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy Child | Self-Efficacy scale: 9-item self-report of confidence in carrying out sleep-related behaviors; Likert scale from 1 (not at all confident) to 10 (totally confident); higher score indicates better self-efficacy. | Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) |
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Inclusion Criteria for Children:
Inclusion criteria for parents:
Exclusion Criteria for Children:
Exclusion criteria for parents:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa M Ward, RN, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington School of Nursing | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40051205 | Derived | Zhai S, Palermo TM, Shenoi S, Demiris G, Howard W, Kientz J, Yuwen W, Ward TM. A shared-management web-based intervention for sleep deficiency in school-age children with juvenile idiopathic arthritis and their parents: feasibility and acceptability study. J Clin Sleep Med. 2025 Jun;21(6):1007-1021. doi: 10.5664/jcsm.11610. Epub 2025 Jun 1. |
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The number of participants in each Milestone represents each child and each parent in the SLEEPSMART Intervention group and each child and each parent in the control group.
We recruited 50 children with JIA and 50 parents.
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| ID | Title | Description |
|---|---|---|
| FG000 | SLEEPSMART PROGRAM | Arm: Experimental -Each child and co-parent dyad will work together to create sleep goals, problem solve and compromise to accomplish the goals, and interact with fields in the Web site. The weekly modules will focus on learning a wind-down and wake-up routine, reducing time in bed, reducing sleep-related worry, negotiating sleep in the environment, correcting unhelpful sleep-related beliefs, and sleep maintenance and relapse prevention. The intervention will last 7 weeks. |
| FG001 | Placebo Comparator (Usual Care) | Arm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| T2 Immediate Post-Intervention |
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| T3 One Month Post-Intervention |
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The overall number of baseline participants reflect EACH child and parent( for the SLEEPSMART program 24 dyads child /co-parent dyads received the SLEEPSMART intervention; and 20 children with JIA and their co-parent were in the control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | SLEEPSMART PROGRAM | Arm: Experimental group 24 children and 24 parents (n=48) that equates to 24 child/co-parent dyads |
| BG001 | Placebo Comparator (Usual Care) | Arm: Placebo Comparator (Usual care) represents 20 children and 20 parents (n=40) that equates to 20 child/co-parent dyads. This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child age | This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Disturbance | PROMIS Sleep Disturbance an 8-item questionnaire that measures self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Items are rated on a 5-point Likert scale (1= not at all/very poor, 2 = a little bit/poor, 3=somewhat/fair, 4=quite a bit/good, 5= very much/very good). The raw scores are converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores suggest more disturbed sleep. | At 2 and 3 months, some participants could not be reached or declined to participate. | Posted | Mean | Standard Deviation | T-score | Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion) |
|
Through study completion, an average of 3 months.
Parents/caregiver and children adverse events reporting were combined by dyad since parents and children were enrolled by dyad. It was a shared management intervention where parents partnered with children and the majority of data was obtained via surveys that are typically low risk for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SLEEPSMART PROGRAM | Arm: Experimental -Each child and parent will partner with a sleep coach to review weekly goals and choose treatment goals. The modules will focus on improving wind down and wake up routines, sleep hygiene, relaxation strategies, correcting unhelpful beliefs about sleep, and the sleep environment. The intervention will last 7 weeks.. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Ward, Professor, Department of Pediatrics | University of Washington | 206-884-1439 | teresa.ward@seattlechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2020 | Jul 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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This pilot RCT, comparing usual care to SLEEPSMART intervention with 60 JIA children and their parents
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| Self-efficacy Parent |
A 9-item survey that assesses parent confidence to manage/control their children's chronic conditions and sleep, emotional functioning, and communication with healthcare providers. Items are rated using a visual analog scale, ranging from 1 = not at all confident to 10 = totally confident. A mean score is calculated with higher values indicative of higher self-efficacy |
| baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Child gender | These numbers represent EACH child and parent | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Child Ethnicity | These numbers represent EACH child and parent | Count of Participants | Participants |
|
| Race (NIH/OMB) | Child race | These numbers represent EACH child and parent. | Count of Participants | Participants |
|
| OG001 | Placebo Comparator (Usual Care) | Arm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. |
|
|
| Primary | Sleep Efficiency | Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep. | At 2 months and 3 months, some participants declined to participate or could not be reached. | Posted | Mean | Standard Deviation | ratio | Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion) |
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| Primary | Sleep Duration | Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period; | Posted | Mean | Standard Deviation | minutes | baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) |
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| Primary | Acceptability of SLEEPSMART | Parent and child survey about the likes and dislikes of the study protocol, areas for improvement, SLEEPSMART program and weekly assignments. Items are scored using a 5-point scale, with 1 equalling strongly disagree and 5 equalling strongly agree. Scores can range from 9 to 45 with higher scores representing greater acceptance. A total score of moderate acceptability for the nine items would be 27. | At 2 months and 3 months, some participants declined to participate or could not be reached. | Posted | Mean | Standard Deviation | score on a scale | 3 months at study completion |
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| Secondary | Self-efficacy Child | Self-Efficacy scale: 9-item self-report of confidence in carrying out sleep-related behaviors; Likert scale from 1 (not at all confident) to 10 (totally confident); higher score indicates better self-efficacy. | At 2 months and 3 months, subjects (3 Placebo and 5 SLEEPSMART Intervention) declined to participate or could not be reached. | Posted | Mean | Standard Deviation | score on a scale | Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) |
|
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| Secondary | Self-efficacy Parent | A 9-item survey that assesses parent confidence to manage/control their children's chronic conditions and sleep, emotional functioning, and communication with healthcare providers. Items are rated using a visual analog scale, ranging from 1 = not at all confident to 10 = totally confident. A mean score is calculated with higher values indicative of higher self-efficacy | At 2 months and 3 months, some particpants declined to participate or could not be reached. | Posted | Mean | Standard Deviation | score on a scale | baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) |
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|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo Comparator (Usual Care) | Arm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|
| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 months |
|
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| 3 months |
|
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| 3 months |
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| 2 Months |
|
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| 3 Months |
|
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| 2 months |
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| 3 months |
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