Trial Outcomes & Findings for Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis (NCT NCT04066205)

Last Updated: 2025-01-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)

Results posted on

2025-01-08

Participant Flow

We recruited 50 children with JIA and 50 parents.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Baseline STARTED	50	50
Baseline COMPLETED	48	40
Baseline NOT COMPLETED	2	10
T2 Immediate Post-Intervention STARTED	48	40
T2 Immediate Post-Intervention COMPLETED	38	34
T2 Immediate Post-Intervention NOT COMPLETED	10	6
T3 One Month Post-Intervention STARTED	38	34
T3 One Month Post-Intervention COMPLETED	38	34
T3 One Month Post-Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
T2 Immediate Post-Intervention Did not respond during intervention or usual care	5	3
T2 Immediate Post-Intervention did not respond	5	3

Baseline Characteristics

This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)

Population: At 2 and 3 months, some participants could not be reached or declined to participate.

Outcome measures

Outcome measures
Measure	SLEEPSMART PROGRAM n=24 Participants Arm: Experimental -Each child and parent will partner with a sleep coach each week to review their weekly goals and choose new treatment goals. The modules will focus on improving wind down and wake up routine, sleep hygiene, relaxation techniques, correcting unhelpful sleep beliefs, and changing the sleep environment. The intervention will last 7 weeks.	Placebo Comparator (Usual Care) n=20 Participants 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.
Sleep Disturbance Baseline	62.1 T-score Standard Deviation 5.4	62.4 T-score Standard Deviation 7.3
Sleep Disturbance 2 months	57.7 T-score Standard Deviation 4.3	58.3 T-score Standard Deviation 7.6
Sleep Disturbance 3 months	56.4 T-score Standard Deviation 2.8	58.5 T-score Standard Deviation 7.1

PRIMARY outcome

Timeframe: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)

Population: At 2 months and 3 months, some participants declined to participate or could not be reached.

Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep.

Outcome measures

Outcome measures
Measure	SLEEPSMART PROGRAM n=24 Participants Arm: Experimental -Each child and parent will partner with a sleep coach each week to review their weekly goals and choose new treatment goals. The modules will focus on improving wind down and wake up routine, sleep hygiene, relaxation techniques, correcting unhelpful sleep beliefs, and changing the sleep environment. The intervention will last 7 weeks.	Placebo Comparator (Usual Care) n=20 Participants 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.
Sleep Efficiency Baseline	.74 ratio Standard Deviation .08	.78 ratio Standard Deviation .05
Sleep Efficiency 2 months	.83 ratio Standard Deviation .05	.79 ratio Standard Deviation .04
Sleep Efficiency 3 months	.84 ratio Standard Deviation .07	.79 ratio Standard Deviation .04

PRIMARY outcome

Timeframe: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)

Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period;

Outcome measures

Outcome measures
Measure	SLEEPSMART PROGRAM n=24 Participants Arm: Experimental -Each child and parent will partner with a sleep coach each week to review their weekly goals and choose new treatment goals. The modules will focus on improving wind down and wake up routine, sleep hygiene, relaxation techniques, correcting unhelpful sleep beliefs, and changing the sleep environment. The intervention will last 7 weeks.	Placebo Comparator (Usual Care) n=20 Participants 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.
Sleep Duration 2 months	508.6 minutes Standard Deviation 57.4	483.6 minutes Standard Deviation 28.1
Sleep Duration 3 months	506.7 minutes Standard Deviation 48.1	488.7 minutes Standard Deviation 33.4
Sleep Duration Baseline	464.0 minutes Standard Deviation 46.7	483.2 minutes Standard Deviation 25.1

PRIMARY outcome

Timeframe: 3 months at study completion

Population: At 2 months and 3 months, some participants declined to participate or could not be reached.

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.

Outcome measures

Outcome measures
Measure	SLEEPSMART PROGRAM n=12 Participants Arm: Experimental -Each child and parent will partner with a sleep coach each week to review their weekly goals and choose new treatment goals. The modules will focus on improving wind down and wake up routine, sleep hygiene, relaxation techniques, correcting unhelpful sleep beliefs, and changing the sleep environment. The intervention will last 7 weeks.	Placebo Comparator (Usual Care) n=12 Participants 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.
Acceptability of SLEEPSMART	34.1 score on a scale Standard Deviation 8.2	36.6 score on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)

Population: At 2 months and 3 months, subjects (3 Placebo and 5 SLEEPSMART Intervention) declined to participate or could not be reached.

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.

Outcome measures

Outcome measures
Measure	SLEEPSMART PROGRAM n=24 Participants Arm: Experimental -Each child and parent will partner with a sleep coach each week to review their weekly goals and choose new treatment goals. The modules will focus on improving wind down and wake up routine, sleep hygiene, relaxation techniques, correcting unhelpful sleep beliefs, and changing the sleep environment. The intervention will last 7 weeks.	Placebo Comparator (Usual Care) n=20 Participants 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.
Self-efficacy Child Baseline	2.5 score on a scale Standard Deviation .8	2.4 score on a scale Standard Deviation 2.8
Self-efficacy Child 2 Months	2.0 score on a scale Standard Deviation .6	2.3 score on a scale Standard Deviation .8
Self-efficacy Child 3 Months	2.0 score on a scale Standard Deviation .8	2.2 score on a scale Standard Deviation .9

SECONDARY outcome

Timeframe: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)

Population: At 2 months and 3 months, some particpants declined to participate or could not be reached.

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

Outcome measures

Outcome measures
Measure	SLEEPSMART PROGRAM n=24 Participants Arm: Experimental -Each child and parent will partner with a sleep coach each week to review their weekly goals and choose new treatment goals. The modules will focus on improving wind down and wake up routine, sleep hygiene, relaxation techniques, correcting unhelpful sleep beliefs, and changing the sleep environment. The intervention will last 7 weeks.	Placebo Comparator (Usual Care) n=20 Participants 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.
Self-efficacy Parent Baseline	5.8 score on a scale Standard Deviation 1.9	6.5 score on a scale Standard Deviation 1.6
Self-efficacy Parent 2 months	7.1 score on a scale Standard Deviation 1.3	6.6 score on a scale Standard Deviation 1.9
Self-efficacy Parent 3 months	7.5 score on a scale Standard Deviation 1.4	7.2 score on a scale Standard Deviation 1.9

Adverse Events

SLEEPSMART PROGRAM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Comparator (Usual Care)

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

Teresa Ward, Professor, Department of Pediatrics

University of Washington

Phone: 206-884-1439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SLEEPSMART PROGRAM n=48 Participants Arm: Experimental group 24 children and 24 parents (n=48) that equates to 24 child/co-parent dyads	Placebo Comparator (Usual Care) n=40 Participants 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.	Total n=88 Participants Total of all reporting groups
Age, Continuous Child	10.1 years STANDARD_DEVIATION 1.7 • n=24 Participants • This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group.	10.5 years STANDARD_DEVIATION 1.8 • n=20 Participants • This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group.	10.3 years STANDARD_DEVIATION 1.7 • n=44 Participants • This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group.
Age, Continuous Parent	40.7 years STANDARD_DEVIATION 5.4 • n=24 Participants • This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group.	43.3 years STANDARD_DEVIATION 6 • n=20 Participants • This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group.	41.95 years STANDARD_DEVIATION 5.7 • n=44 Participants • This represent EACH child and EACH parent in SLEEPSMART Group AND Control Group.
Sex: Female, Male Child · Female	18 Participants n=24 Participants • These numbers represent EACH child and parent	18 Participants n=20 Participants • These numbers represent EACH child and parent	36 Participants n=44 Participants • These numbers represent EACH child and parent
Sex: Female, Male Child · Male	6 Participants n=24 Participants • These numbers represent EACH child and parent	2 Participants n=20 Participants • These numbers represent EACH child and parent	8 Participants n=44 Participants • These numbers represent EACH child and parent
Sex: Female, Male Parent · Female	24 Participants n=24 Participants • These numbers represent EACH child and parent	20 Participants n=20 Participants • These numbers represent EACH child and parent	44 Participants n=44 Participants • These numbers represent EACH child and parent
Sex: Female, Male Parent · Male	0 Participants n=24 Participants • These numbers represent EACH child and parent	0 Participants n=20 Participants • These numbers represent EACH child and parent	0 Participants n=44 Participants • These numbers represent EACH child and parent
Ethnicity (NIH/OMB) Child · Hispanic or Latino	4 Participants n=24 Participants • These numbers represent EACH child and parent	6 Participants n=20 Participants • These numbers represent EACH child and parent	10 Participants n=44 Participants • These numbers represent EACH child and parent
Ethnicity (NIH/OMB) Child · Not Hispanic or Latino	20 Participants n=24 Participants • These numbers represent EACH child and parent	14 Participants n=20 Participants • These numbers represent EACH child and parent	34 Participants n=44 Participants • These numbers represent EACH child and parent
Ethnicity (NIH/OMB) Child · Unknown or Not Reported	0 Participants n=24 Participants • These numbers represent EACH child and parent	0 Participants n=20 Participants • These numbers represent EACH child and parent	0 Participants n=44 Participants • These numbers represent EACH child and parent
Ethnicity (NIH/OMB) Parent · Hispanic or Latino	4 Participants n=24 Participants • These numbers represent EACH child and parent	5 Participants n=20 Participants • These numbers represent EACH child and parent	9 Participants n=44 Participants • These numbers represent EACH child and parent
Ethnicity (NIH/OMB) Parent · Not Hispanic or Latino	20 Participants n=24 Participants • These numbers represent EACH child and parent	15 Participants n=20 Participants • These numbers represent EACH child and parent	35 Participants n=44 Participants • These numbers represent EACH child and parent
Ethnicity (NIH/OMB) Parent · Unknown or Not Reported	0 Participants n=24 Participants • These numbers represent EACH child and parent	0 Participants n=20 Participants • These numbers represent EACH child and parent	0 Participants n=44 Participants • These numbers represent EACH child and parent
Race (NIH/OMB) Child · American Indian or Alaska Native	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Child · Asian	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Child · Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Child · Black or African American	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Child · White	20 Participants n=24 Participants • These numbers represent EACH child and parent.	17 Participants n=20 Participants • These numbers represent EACH child and parent.	37 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Child · More than one race	2 Participants n=24 Participants • These numbers represent EACH child and parent.	2 Participants n=20 Participants • These numbers represent EACH child and parent.	4 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Child · Unknown or Not Reported	2 Participants n=24 Participants • These numbers represent EACH child and parent.	1 Participants n=20 Participants • These numbers represent EACH child and parent.	3 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Parent · American Indian or Alaska Native	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Parent · Asian	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Parent · Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Parent · Black or African American	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Parent · White	21 Participants n=24 Participants • These numbers represent EACH child and parent.	17 Participants n=20 Participants • These numbers represent EACH child and parent.	38 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Parent · More than one race	3 Participants n=24 Participants • These numbers represent EACH child and parent.	3 Participants n=20 Participants • These numbers represent EACH child and parent.	6 Participants n=44 Participants • These numbers represent EACH child and parent.
Race (NIH/OMB) Parent · Unknown or Not Reported	0 Participants n=24 Participants • These numbers represent EACH child and parent.	0 Participants n=20 Participants • These numbers represent EACH child and parent.	0 Participants n=44 Participants • These numbers represent EACH child and parent.