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| ID | Type | Description | Link |
|---|---|---|---|
| P30NR016585 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Behavioral sleep problems such as sleep onset delays and frequent night wakings are common among young children (2-5 years). Children with a chronic health condition such as juvenile idiopathic arthritis (JIA) are even more prone to sleep problems, which are also associated with disease-related symptoms such as pain and fatigue. Early childhood is a critical period for establishing healthy sleep habits and self-regulation skills and is therefore an opportune time to identify and address unhealthy sleep habits. The Sleep Innovation for Preschoolers with Arthritis (SIPA) project will develop and pilot test a technology-based sleep intervention for parents of young children with JIA.
The SIPA study aims to develop and test the usability, feasibility, acceptability, and preliminary effectiveness of a technology-based sleep intervention - Sleep Innovation for Preschoolers with Arthritis (SIPA) - that provides JIA parents with the necessary tools (self-efficacy, motivation, activation) to set goals, problem solve, and improve sleep in young children with JIA. SIPA will address the causes of sleep deficiency including behavioral sleep problems (e.g., sleep onset delay, frequent night awakenings, and sleep onset association disorder) in preschoolers with JIA using a single-arm pre- and post-test pilot study. Investigators will pilot test the intervention with 18 parents and preschoolers with JIA. Investigators will assess the feasibility and acceptability of the intervention among users, as will as analyze its preliminary effectiveness in terms of changes in behavioral sleep problems in the preschoolers pre- and post-intervention. The specific aims are to:
Aim 1. Apply a user-centered iterative design approach to develop and test the usability of a technology- based sleep self-management intervention - Sleep Innovation for Preschoolers with Arthritis (SIPA) - for 2-5-year-old children (preschoolers) with juvenile idiopathic arthritis (JIA).
2. Describe the feasibility, acceptability, and preliminary effectiveness of the SIPA intervention to address the causes of behavioral sleep problems (e.g., frequent night awakenings, and sleep onset association disorder) that are the main cause of sleep deficiency in preschoolers with JIA using a single-arm pre- and post-test pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 8-weeks online program with weekly modules for parents to learn about specific sleep topics and implement behavioral changes to improve their child's sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Innovations for Preschoolers with Arthritis (SIPA) | Behavioral | The SIPA intervention is interactive and personalized. Every week, parent will receive an email sent automatically through the system with instructions for this week's activity, designed to take about 30 minutes to complete. The SIPA weekly modules will begin with a learning module, then direct participants through goal setting, anticipated barriers, and problem solving. The intervention site will include fillable responses to queries, instructions, and assignments. Tasks for parents and their young children will use multimedia elements to enhance delivery of information, such as links to videos and pictures targeting self-efficacy, motivation, and patient activation. Submissions and progress will be monitored by the study team, who will send email, call or text with reminders (whichever the family prefers) and answer questions as needed, review progress, and help problem solve any technology issues or barriers to implementing skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Assessed by Adherence | Adherence is calculated by the total number of dyads completing all intervention modules divided by the total number of dyads enrolled. | immediately after intervention |
| Children's Sleep Habits Questionnaire | The Children's Sleep Habits Questionnaire (CSHQ) is a survey that assesses a child's sleep quality and quantity by asking parents to report on their child's sleep habits. The CSHQ has 45 items, including 33 scored questions and seven additional items. Parents rate each scored question on a three-point scale: usually, sometimes, and rarely. The total Sleep Disturbances score is calculated by adding up all the scored questions. All responses are totaled to create a Total Sleep Disturbance index (range from 33-99), with a score exceeding 41 suggesting the presence of a pediatric sleep disorder. | baseline; 8 weeks (immediately after 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 |
|---|---|---|
| Weichao Yuwen, PhD, RN | University of Washington- Tacoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of washington | Seattle | Washington | 98195 | United States |
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| Label | URL |
|---|---|
| SIPA Website | View source |
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The numbers are parent-child dyads, each dyad consist of one parent and one child.
Enrollment happened from 2020.5.1 - 2020.11.12 at a local medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 8-weeks online program with weekly modules for parents to learn about specific sleep topics and implement behavioral changes to improve their child's sleep. Sleep Innovations for Preschoolers with Arthritis (SIPA): The SIPA intervention is interactive and personalized. Every week, parent will receive an email sent automatically through the system with instructions for this week's activity, designed to take about 30 minutes to complete. The SIPA weekly modules will begin with a learning module, then direct participants through goal setting, anticipated barriers, and problem solving. The intervention site will include fillable responses to queries, instructions, and assignments. Tasks for parents and their young children will use multimedia elements to enhance delivery of information, such as links to videos and pictures targeting self-efficacy, motivation, and patient activation. Submissions and progress will be monitored by the study team, who will send email, call or text with reminders (whichever the family prefers) and answer questions as needed, review progress, and help problem solve any technology issues or barriers to implementing skills. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 5, 2022 |
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| COMPLETED |
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| NOT COMPLETED |
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16 children; because this intervention is intended to improve children's sleep outcomes, we only collected demographic information about the children.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 8-weeks online program with weekly modules for parents to learn about specific sleep topics and implement behavioral changes to improve their child's sleep. Sleep Innovations for Preschoolers with Arthritis (SIPA): The SIPA intervention is interactive and personalized. Every week, parent will receive an email sent automatically through the system with instructions for this week's activity, designed to take about 30 minutes to complete. The SIPA weekly modules will begin with a learning module, then direct participants through goal setting, anticipated barriers, and problem solving. The intervention site will include fillable responses to queries, instructions, and assignments. Tasks for parents and their young children will use multimedia elements to enhance delivery of information, such as links to videos and pictures targeting self-efficacy, motivation, and patient activation. Submissions and progress will be monitored by the study team, who will send email, call or text with reminders (whichever the family prefers) and answer questions as needed, review progress, and help problem solve any technology issues or barriers to implementing skills. |
| 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 | 16 completed the demographic survey | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | 16/16 | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | 16 completed the demographic survey | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | 16 completed the demographic survey | Count of Participants | Participants |
| |||||||||||||||||
| Children's Sleep Habits Questionnaire | The Children's Sleep Habits Questionnaire (CSHQ) is a survey that assesses a child's sleep quality and quantity by asking parents to report on their child's sleep habits. The CSHQ has 45 items, including 33 scored questions and seven additional items. Parents rate each scored question on a three-point scale: usually, sometimes, and rarely. The total Sleep Disturbances score is calculated by adding up all the scored questions. All responses are totaled to create a Total Sleep Disturbance index (range from 33-99), with a score exceeding 41 suggesting the presence of a pediatric sleep disorder. | 16 completed | Mean | Standard Deviation | units on a scale |
|
| 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 | Feasibility as Assessed by Adherence | Adherence is calculated by the total number of dyads completing all intervention modules divided by the total number of dyads enrolled. | Posted | Count of Participants | Participants | immediately after intervention |
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| Primary | Children's Sleep Habits Questionnaire | The Children's Sleep Habits Questionnaire (CSHQ) is a survey that assesses a child's sleep quality and quantity by asking parents to report on their child's sleep habits. The CSHQ has 45 items, including 33 scored questions and seven additional items. Parents rate each scored question on a three-point scale: usually, sometimes, and rarely. The total Sleep Disturbances score is calculated by adding up all the scored questions. All responses are totaled to create a Total Sleep Disturbance index (range from 33-99), with a score exceeding 41 suggesting the presence of a pediatric sleep disorder. | Posted | Mean | Standard Deviation | score on a scale | baseline; 8 weeks (immediately after intervention); and 3 months (study completion). |
|
10 months
for child only; adverse event for parents were not collected.
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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 | Intervention Group | 8-weeks online program with weekly modules for parents to learn about specific sleep topics and implement behavioral changes to improve their child's sleep. Sleep Innovations for Preschoolers with Arthritis (SIPA): The SIPA intervention is interactive and personalized. Every week, parent will receive an email sent automatically through the system with instructions for this week's activity, designed to take about 30 minutes to complete. The SIPA weekly modules will begin with a learning module, then direct participants through goal setting, anticipated barriers, and problem solving. The intervention site will include fillable responses to queries, instructions, and assignments. Tasks for parents and their young children will use multimedia elements to enhance delivery of information, such as links to videos and pictures targeting self-efficacy, motivation, and patient activation. Submissions and progress will be monitored by the study team, who will send email, call or text with reminders (whichever the family prefers) and answer questions as needed, review progress, and help problem solve any technology issues or barriers to implementing skills. | 0 | 16 | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weichao Yuwen | University of Washington | 2536924478 | wyuwen@uw.edu |
| Sep 5, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2019 | Feb 1, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| 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 |
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| Unknown or Not Reported |
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