Trial Outcomes & Findings for Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention (NCT NCT04354337)
NCT ID: NCT04354337
Last Updated: 2025-03-10
Results Overview
Adherence is calculated by the total number of dyads completing all intervention modules divided by the total number of dyads enrolled.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
immediately after intervention
Results posted on
2025-03-10
Participant Flow
Enrollment happened from 2020.5.1 - 2020.11.12 at a local medical clinic
The numbers are parent-child dyads, each dyad consist of one parent and one child.
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
16 completed the demographic survey
Baseline characteristics by cohort
| Measure |
Intervention Group
n=16 Participants
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.
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|---|---|
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Age, Continuous
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3.6 years
STANDARD_DEVIATION 1.1 • n=5 Participants • 16 completed the demographic survey
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Sex: Female, Male
Female
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12 Participants
n=5 Participants • 16/16
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Sex: Female, Male
Male
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4 Participants
n=5 Participants • 16/16
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants • 16 completed the demographic survey
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=5 Participants • 16 completed the demographic survey
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • 16 completed the demographic survey
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants • 16 completed the demographic survey
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants • 16 completed the demographic survey
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=5 Participants • 16 completed the demographic survey
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants • 16 completed the demographic survey
|
|
Race (NIH/OMB)
White
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11 Participants
n=5 Participants • 16 completed the demographic survey
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants • 16 completed the demographic survey
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • 16 completed the demographic survey
|
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Children's Sleep Habits Questionnaire
|
48.36 units on a scale
STANDARD_DEVIATION 8.05 • n=5 Participants • 16 completed
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PRIMARY outcome
Timeframe: immediately after interventionAdherence is calculated by the total number of dyads completing all intervention modules divided by the total number of dyads enrolled.
Outcome measures
| Measure |
Intervention Group
n=16 Participants
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.
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|---|---|
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Feasibility as Assessed by Adherence
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12 Participants
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PRIMARY outcome
Timeframe: baseline; 8 weeks (immediately after intervention); and 3 months (study completion).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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
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.
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|---|---|
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Children's Sleep Habits Questionnaire
baseline
|
48.36 score on a scale
Standard Deviation 8.05
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Children's Sleep Habits Questionnaire
8 weeks
|
40.82 score on a scale
Standard Deviation 5.53
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Children's Sleep Habits Questionnaire
3 months
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38.90 score on a scale
Standard Deviation 2.81
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Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place