Autism Spectrum Disorder, Insomnia
Conditions
Keywords
sleep, autism
Brief summary
This proposal will acquire preliminary data on the feasibility and effectiveness of an innovative and scalable strategy for improving access to effective sleep health care for preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop and test an on-line delivery adaptation of the existing behavioral sleep interventions for preschool aged children.
Detailed description
Access to effective treatments for sleep disorders is a persistent challenge. This is due to the lack of trained clinicians as well as caregiver resources to seek out and utilize such critical services. The SweetDreams intervention will solve this problem with on-line delivery of educational materials and treatment strategies for an evidence-based intervention. It will be readily available to caregivers at any time and through multiple outlets such a computer, tablet, and telephone, modes of delivery favored by and effective for parents of children in this age group. This adaptation will address key challenges to sleep health care for children with ASD: (1) Learning differences of children with ASD by incorporating intervention principles from the TEACHH model; (2) Overcome the challenge of treatment access due to the limited number of qualified providers by developing didactic videos for online and mobile device delivery (referred to as SweetDreams); and, (3) Responding to the NIH emphasis on developing more effective interventions…by targeting interventions to the identified needs of community members, SweetDreams will use a dynamic process involving extensive collaboration with children, parents, developmental pediatricians, and other experts on youth with ASD.
Interventions
DEVICESweetDreams
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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 60 Months
Healthy volunteers
Yes
Inclusion criteria
* have poor sleep health * have a diagnosis of ASD
Exclusion criteria
* any regular sleep medication use (this does not include occasional over the counter sleep aid) * known sleep apnea * unstable major medical conditions (e.g. severe asthma, diabetes).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Children's Sleep Habits Questionnaire (CSHQ) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Waitlist Control Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | Waitlist Control | Total | SweetDreams |
|---|---|---|---|
| Age, Continuous | 46.27 months STANDARD_DEVIATION 10.9 | 46.2 months STANDARD_DEVIATION 9.06 | 46.11 months STANDARD_DEVIATION 6.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 15 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
Primary
Change in Children's Sleep Habits Questionnaire (CSHQ)
Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems
Time frame: baseline to end of treatment (average exposure 1 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SweetDreams | Change in Children's Sleep Habits Questionnaire (CSHQ) | -8.78 units on a scale | Standard Deviation 12.3 |
| Waitlist Control | Change in Children's Sleep Habits Questionnaire (CSHQ) | -.59 units on a scale | Standard Deviation 12.7 |
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI)
Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
Time frame: baseline to end of treatment (average exposure 1 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SweetDreams | Change in Pittsburgh Sleep Quality Index (PSQI) | -3.36 units on a scale | Standard Deviation 4.17 |
| Waitlist Control | Change in Pittsburgh Sleep Quality Index (PSQI) | .24 units on a scale | Standard Deviation 3.99 |