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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SweetDreams | Experimental | Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. |
|
| Waitlist Control | No Intervention | Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SweetDreams | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Children's Sleep Habits Questionnaire (CSHQ) | Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems | baseline to end of treatment (average exposure 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) | Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality | baseline to end of treatment (average exposure 1 month) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Asarnow, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Waitlist Control | Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Children's Sleep Habits Questionnaire (CSHQ) | Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems | Posted | Mean | Standard Deviation | units on a scale | baseline to end of treatment (average exposure 1 month) |
|
baseline to end of treatment (average exposure 1 month)
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Asarnow | University of California, San Francisco | (415) 353-2273 | lauren.asarnow@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 5, 2021 | Nov 18, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| BG001 |
| Waitlist Control |
Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) | Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality | Posted | Mean | Standard Deviation | units on a scale | baseline to end of treatment (average exposure 1 month) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Waitlist Control | Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |