Trial Outcomes & Findings for SweetDreams Sleep Study for Children With Autism (NCT NCT04452045)
NCT ID: NCT04452045
Last Updated: 2025-12-02
Results Overview
Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
baseline to end of treatment (average exposure 1 month)
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
SweetDreams
Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
SweetDreams: SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
|
Waitlist Control
Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SweetDreams Sleep Study for Children With Autism
Baseline characteristics by cohort
| Measure |
SweetDreams
n=9 Participants
Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
SweetDreams: SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
|
Waitlist Control
n=11 Participants
Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.11 months
STANDARD_DEVIATION 6.74 • n=121 Participants
|
46.27 months
STANDARD_DEVIATION 10.9 • n=122 Participants
|
46.2 months
STANDARD_DEVIATION 9.06 • n=243 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=121 Participants
|
10 Participants
n=122 Participants
|
15 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=121 Participants
|
9 Participants
n=122 Participants
|
15 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=121 Participants
|
4 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: baseline to end of treatment (average exposure 1 month)Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems
Outcome measures
| Measure |
SweetDreams
n=9 Participants
Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
SweetDreams: SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
|
Waitlist Control
n=11 Participants
Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
|
|---|---|---|
|
Change in Children's Sleep Habits Questionnaire (CSHQ)
|
-8.78 units on a scale
Standard Deviation 12.3
|
-.59 units on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: baseline to end of treatment (average exposure 1 month)Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
Outcome measures
| Measure |
SweetDreams
n=9 Participants
Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
SweetDreams: SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
|
Waitlist Control
n=11 Participants
Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
|
-3.36 units on a scale
Standard Deviation 4.17
|
.24 units on a scale
Standard Deviation 3.99
|
Adverse Events
SweetDreams
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
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
Lauren Asarnow
University of California, San Francisco
Phone: (415) 353-2273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place