An interventional study of SLEEPSAMRT in Juvenile Idiopathic Arthritis, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
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.
359 studies on the registry are indexed under Arthritis, Juvenile; 95 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 229 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Inclusion Criteria for Children:
Inclusion criteria for parents:
Exclusion Criteria for Children:
Exclusion criteria for parents:
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.
Behavioral: SLEEPSAMRT
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.
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.
Time frame: 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.
Time frame: 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;
Time frame: 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.
Time frame: 3 months at study completion
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.
Time frame: Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
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
Time frame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
We recruited 50 children with JIA and 50 parents.
| Milestone | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Started | 50 | 50 |
| Completed | 48 | 40 |
| Not completed | 2 | 10 |
| Milestone | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Started | 48 | 40 |
| Completed | 38 | 34 |
| Not completed | 10 | 6 |
| Withdrew: Did not respond during intervention or usual care | 5 | 3 |
| Withdrew: Did not respond | 5 | 3 |
| Milestone | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Started | 38 | 34 |
| Completed | 38 | 34 |
| Not completed | 0 | 0 |
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.
| T-score | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Baseline | 62.1 ± 5.4 | 62.4 ± 7.3 |
| 2 months | 57.7 ± 4.3 | 58.3 ± 7.6 |
| 3 months | 56.4 ± 2.8 | 58.5 ± 7.1 |
Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep.
| ratio | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Baseline | .74 ± .08 | .78 ± .05 |
| 2 months | .83 ± .05 | .79 ± .04 |
| 3 months | .84 ± .07 | .79 ± .04 |
Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period;
| minutes | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Baseline | 464.0 ± 46.7 | 483.2 ± 25.1 |
| 2 months | 508.6 ± 57.4 | 483.6 ± 28.1 |
| 3 months | 506.7 ± 48.1 | 488.7 ± 33.4 |
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.
| score on a scale | SLEEPSMART Child | SLEEPSMART Parent |
|---|---|---|
| Acceptability of SLEEPSMART | 34.1 ± 8.2 | 36.6 ± 6.4 |
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.
| score on a scale | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Baseline | 2.5 ± .8 | 2.4 ± 2.8 |
| 2 Months | 2.0 ± .6 | 2.3 ± .8 |
| 3 Months | 2.0 ± .8 | 2.2 ± .9 |
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
| score on a scale | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) |
|---|---|---|
| Baseline | 5.8 ± 1.9 | 6.5 ± 1.6 |
| 2 months | 7.1 ± 1.3 | 6.6 ± 1.9 |
| 3 months | 7.5 ± 1.4 | 7.2 ± 1.9 |
Collected over Through study completion, an average of 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SLEEPSMART PROGRAM | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Placebo Comparator (Usual Care) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
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.
| Age, Continuous(years) | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) | Total |
|---|---|---|---|
| Child | 10.1 ± 1.7 | 10.5 ± 1.8 | 10.3 ± 1.7 |
| Parent | 40.7 ± 5.4 | 43.3 ± 6 | 41.95 ± 5.7 |
| Sex: Female, Male(Participants) | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) | Total |
|---|---|---|---|
| Child — Female | 18 | 18 | 36 |
| Child — Male | 6 | 2 | 8 |
| Parent — Female | 24 | 20 | 44 |
| Parent — Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) | Total |
|---|---|---|---|
| Child — Hispanic or Latino | 4 | 6 | 10 |
| Child — Not Hispanic or Latino | 20 | 14 | 34 |
| Child — Unknown or Not Reported | 0 | 0 | 0 |
| Parent — Hispanic or Latino | 4 | 5 | 9 |
| Parent — Not Hispanic or Latino | 20 | 15 | 35 |
| Parent — Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) | Total |
|---|---|---|---|
| Child — American Indian or Alaska Native | 0 | 0 | 0 |
| Child — Asian | 0 | 0 | 0 |
| Child — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Child — Black or African American | 0 | 0 | 0 |
| Child — White | 20 | 17 | 37 |
| Child — More than one race | 2 | 2 | 4 |
| Child — Unknown or Not Reported | 2 | 1 | 3 |
| Parent — American Indian or Alaska Native | 0 | 0 | 0 |
| Parent — Asian | 0 | 0 | 0 |
| Parent — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Parent — Black or African American | 0 | 0 | 0 |
| Parent — White | 21 | 17 | 38 |
| Parent — More than one race | 3 | 3 | 6 |
| Parent — Unknown or Not Reported | 0 | 0 | 0 |
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