Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study
Phase: NA
Conditions: Autism Spectrum Disorder, Insomnia
Sponsor: University of California, San Francisco

Feasibility of a Sleep Intervention for Children 
with Autism Spectrum Disorder Study 
 
NCT04452045 
October 5, 2021 

Study Application (Version 1.7)
1.0
General Information
*Enter the full title of your study:
Feasibility of a Sleep Intervention for Children with Autism Spectrum Disorder
 
 
*Enter the study alias:
RAS # A127552
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add departments
2.1 and Specify Research Location:
Is 
Primary? Department Name
UCSF - 
 - M_Psychiatry
133100
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Asarnow, Lauren D PhD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Bush, Nicole PhD 
 Other Investigator
Leventhal, Bennett MD 
 Other Investigator
B) Research Support Staff
Mirchandaney, Riya 
 Study Coordinator
l

3.3 *Please add a Study Contact
 
Asarnow, Lauren D PhD 
Mirchandaney, Riya 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
Leventhal, Bennett MD
3.5 If applicable, please select the Designated Department Approval(s)
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 
Initial Screening Questions 
Updated April 2020 - Revised Common Rule (January 2018) Compliant / COVID-19 - 
v94
4.1  * 
:
PROJECT SUMMARY  (REQUIRED) Give a brief overview of this project (250 words or less). Tell us 
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH 
Abstract, paste it here (Click on the orange question mark to the right for more detailed instructions):
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 ASD. We will develop and test an adaptation of the existing behavioral sleep 
interventions for preschool aged children. 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) SweetDreams will use a dynamic 
process involving extensive collaboration with children, parents, developmental pediatricians, and 
other experts on youth with ASD.
4.2  
 
* 
:
HUD DEVICE (REQUIRED) 
 
Does this application involve a Humanitarian Use Device (HUD):
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  * 
: 
TYPE OF RESEARCH (REQUIRED) 
(
Select the option that best fits your project Click the orange 
question mark to the right for definitions and guidance):
Biomedical research (including medical records review, biospecimen collection and/or use, 
other healthcare or health outcomes related activities, research database, biospecimen bank, 
or recruitment registry) 
Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is 
mainly social/behavioral but also involves specimen collection or blood draws to look at 

biological measures) 
4.4  * 
 
SUBJECT CONTACT: (REQUIRED) Does this study involve 
 contact or interactions with 
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  
 
* RISK LEVEL: (REQUIRED) What is your estimation of the risk level, including all screening 
:
procedures and study activities
Minimal risk 
Greater than minimal risk 
4.6  * REVIEW LEVEL: (REQUIRED) Requested review level (Click on the orange question mark to the 
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 
4.7  
 
* EXPEDITED REVIEW CATEGORIES: (REQUIRED) If you think this study qualifies for expedited 
 
 
review, select the regulatory categories that the research falls under: (check all that apply)
Category 1: Research using approved drugs or devices being used for their approved 
indications
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture 
in certain populations and within certain amounts
Category 3: Prospective collection of biological specimens for research purposes by 
noninvasive means (e.g. buccal swabs, urine, hair and nail clippings, etc.)
Category 4: Collection of data through noninvasive, routine clinical procedures (e.g. physical 
sensors such as pulse oximeters, MRI, EKG, EEG, ultrasound, moderate exercise testing, etc. 
- no sedation, general anesthesia, x-rays or microwaves)
Category 5: Research involving materials (data, documents, records, or specimens) that have 
been or will be collected solely for nonresearch purposes
Category 6: Collection of data from voice, video, digital, or image recordings made for 
research purposes
Category 7: Research on individual or group characteristics or behavior or research employing 
survey, interview, oral history, focus group, program evaluation, human factorsevaluation, or 
quality assurance methodologies
4.9  
 
* DATA/SPECIMEN ANALYSIS ONLY: (REQUIRED) Does this study 
 involve records review and
ONLY
/or biospecimen analysis (do not check 'Yes' if this is a registry, research or recruitment database, or 
biospecimen repository):
  Yes  
  No
4.10  
 
* CLINICAL TRIAL: (REQUIRED)
Is this a clinical trial:
According to The World Health Organization (WHO) and the 
International Committee of Medical Journal Editors (ICMJE) a 
clinical trial is:

Any research study that prospectively assigns human participants or 
groups of humans to one or more health-related interventions to 
evaluate the effects on health outcomes.
ICMJE requires 
 of a clinical trial in a public database (such as 
registration
ClinicalTrials.gov) prior to enrollment, for eventual publication of results in 
member biomedical journals.
Public Law 110-85 requires that all investigators who perform 
Guidance: 
an 
 must ensure that the trial is registered on a 
applicable clinical trial
 
.
government web site called ClinicalTrials.gov
 
The FDA requires registration for 'applicable clinical trials,' defined 
as follows:
For any trials of drugs and biologics: controlled clinical investigations, 
other than Phase 1 investigations, of a product subject to FDA 
regulation.
For trials of biomedical devices: controlled trials with health outcomes 
of devices subject to FDA regulation, other than small feasibility 
studies, and pediatric post-market surveillance.
 
 
For additional information on the ClinicalTrials.gov registration process at 
UCSF and the definition of a clinical trial for purposes of registration, visit 
 
the ClinicalTrials.gov section of the UCSF Clinical Research Resource 
HUB.
 
 
 Yes  
 No
 - 'NCT' number for this trial:
Clinical Trial Registration
NCT04452045
4.11  * 
: 
CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s):
Phase 0
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
Phase 4
Not Applicable
4.12  
: 
* INVESTIGATOR-INITIATED (REQUIRED) Is this an investigator-initiated study:
 Yes  
 No
 of the 
 to 
The UCSF IRB recommends use
Virtual Regulatory Binder
manage your study.
4.13  * 
 
CORONAVIRUS RESEARCH: (REQUIRED) Does this study involve research on coronaviruses (COVID-
19, SARS, MERS or other):

  Yes  
  No
4.15  
 
*
 
CANCER: (REQUIRED) Does this study involve cancer (e.g., the study involves patients with cancer 
or at risk for cancer, including behavioral research, epidemiological research, public policy research, 
specimen analysis, and chart reviews):
  Yes  
  No
4.16  * 
 
RADIATION EXPOSURE: (REQUIRED) Does your protocol involve any radiation exposure to patients
/subjects 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-
EITHER
standard care OR 
research
guided biopsy, radiation therapy, or nuclear medicine including PET, MUGA or bone scans):
  Yes  
  No
4.17  SCIENTIFIC REVIEW: If this study has undergone scientific or scholarly review, please indicate 
which entity performed the review (check all that apply):
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final IRB 
approval for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Departmental scientific review
Other:
4.18  
 
* STEM CELLS: (REQUIRED) 
 
Does this study involve
 
human stem cells (including iPS cells and adult 
stem cells), gametes or embryos:
No 
Yes, and requires IRB and GESCR review 
Yes, and requires GESCR review, but NOT IRB review 
4.19  
 
 
*
 
FINANCIAL INTERESTS: (REQUIRED) Do you or any other responsible personnel (or the spouse, 
 
 
registered domestic partner and/or dependent children thereof) have financial interests related to 
 
this study:
  Yes  
  No
5.0
 Funding
5.1  
 
* FEDERAL FUNDING: (REQUIRED) Is this study currently supported in whole or in part by Federal 
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
 Yes  
 No
5.2  
 
* 
Is this project linked in any way to the Department of Defense (DoD):
DoD INVOLVEMENT: 
(REQUIRED)
  Yes  
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:

External Sponsors:
 
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution:
Contract 
Type:
Project 
Number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
NIH Natl Ctr 
Advancing 
Translational Sci 
01 
UCSF 
Grant 
 
 
Sponsor Name:
NIH Natl Ctr Advancing Translational Sci 
Sponsor Type:
01 
Sponsor Role:
Funding
CFDA Number:
 
Grant/Contract Number:
 
Awardee Institution::
UCSF 
Is Institution the Primary 
Grant Holder:
Yes 
Contract Type:
Grant 
Project Number:
 
UCSF RAS System Award 
Number ("A" + 6 digits):
 
Grant Number for Studies Not 
Funded thru UCSF:
 
Grant Title:
 
PI Name:
(If PI is not the same as 
identified on the study.)
 
Explain Any Significant 
Discrepancy:
 
Other Funding Sources and Unfunded Research - Gift, Program, 
Departmental or other Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
* Identify the gift, program, departmental, or other internal funding source: 
(REQUIRED)
NIH Natl Ctr Advancing Translational Sci
6.0
 Sites, Programs, Resources, and External IRB Review
6.1    
  
 (check all that apply): 
 UCSF AND AFFILIATED SITES
*
(REQUIRED)  
UCSF Benioff Children's Hospital Oakland (BCHO)
UCSF Cancer Center Berkeley

UCSF Cancer Center San Mateo
UCSF China Basin clinics and facilities
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF Langley Porter Psychiatric Institute (LPPI)
UCSF Medical Center at Mission Bay (Benioff Children's Hospital, the Betty Irene Moore 
Women's Hospital, Bakar Cancer Hospital, or outpatient clinics)
UCSF Mount Zion
UCSF Parnassus (Moffitt-Long hospital, dental clinics or other outpatient clinics)
UCSF Other Sites (including Laurel Heights and all the other sites outside the main hospitals 
and clinics)
Fresno - UCSF Fresno OR Community Medical Center (CMC)
Gladstone Institutes
Institute on Aging (IOA)
Jewish Home
SF Dept of Public Health (DPH)
SF VA Medical Center (SF VAMC)
Vitalant (formerly Blood Centers of the Pacific and Blood Systems Research Institute)
Zuckerberg San Francisco General (ZSFG)
6.2  
At what locations will study visits and activities occur:
LOCATIONS: 
At this time, all study visits will take place over Zoom.
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
  Yes  
  No
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research 
 units or utilize 
:
Services (CRS)
CRS services
  Yes  
  No
6.6  * MULTI-CENTER TRIAL: (REQUIRED) Is this a multi-center or multi-site research trial:
By 
' we mean a study where the protocol is developed 
'multi-center trial
by an lead investigator, an industry sponsor, consortium, a disease-group, 
etc.,and multiple sites across the nation or in different countries participate 
in the trial. The local sites do not have any control over the design of the 
protocol.
  Yes  
  No

6.8  OTHER SITE TYPES: Check all the other types of sites not affiliated with UCSF with which you are 
cooperating or collaborating on this project:
Do NOT check any boxes below if this is a multi-center clinical 
trial, UCSF is just one of the sites, and neither UCSF nor one of its 
faculty-linked affiliates (SF VAMC, Gladstone, ZSFG) are the 
coordinating center.
Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.14  * RELYING ON AN EXTERNAL IRB: (REQUIRED) Does this application include a request to rely on an 
external IRB (a central IRB (other than the NCI CIRB) or an external IRB (other UC campus, 
commercial, or institutional):
  Yes  
  No
7.0
 Research Plan and Procedures
7.1  
Describe the hypothesis or what the study hopes to prove:
HYPOTHESIS: 
We hypothesize that the SweetDreams intervention will improve child sleep and behavior as well 
as the sleep and mental health of their caregivers.
7.2  
List the specific aims:
AIMS: 
Aim 1a: In Phase I we will develop and assess the acceptability of the SweetDreams sleep 
intervention for youth with ASD, using existing, evidence-based behavioral sleep interventions for 
mobile device delivery.
Aim 1b: Use an iterative intervention development process to pre-test the intervention with 5 
children and their parents to make sure that it is user-friendly, developmentally appropriate, 
engaging, and acceptable. After reviewing initial quantitative and qualitative data on usability, 
acceptability, and outcomes, we will refine the intervention and pre-test the refined intervention 
with 5 more children and their parents. This will be followed by a final set of revisions, as needed.
Aim 2: In Phase II we will conduct a pilot RCT in which 20 children (12-60 months) with ASD and 
sleep problems will be randomized to SweetDreams (n=10) or a wait-list control (n=10) to assess 
the effectiveness of SweetDreams. We hypothesize that SweetDreams will result in improved 
sleep behaviors as measured by the Children’s Sleep Habits Questionnaire (H1a: Primary 
Outcome) and the Pittsburgh Sleep Quality Index for the caregivers (H1b; Secondary hypothesis), 
compared to wait-list control.
Aim 3: Explore the effects of SweetDreams on child behavior and caregiver mental health 
outcomes. We test the hypothesis that SweetDreams results in improvements in multiple domains 
of child behavior and caregiver mental health, using caregiver reports of child behavior and 
caregiver self-report measures, compared to the wait-list control condition.
7.3  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
DESIGN: 
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  

This treatment development trial will develop (Phase I) and evaluate the potential efficacy of 
SweetDreams in a pilot randomized controlled trial among parents of preschool aged children with 
ASD and a sleep problem (Phase II). Phase II will include a waitlist control group, which will be 
given access to SweetDreams following the post-treatment assessment.
7.4  
 Briefly provide the background and significance of this study (e.g. 
BACKGROUND AND SIGNIFICANCE:
 
why is this study needed) (space limit: one half page):
Sleep problems are one of the most common concurrent clinical disorders among children 
with Autism Spectrum Disorder (ASD), with a prevalence ranging from 40% to 80% Based on 
parental reports, Krakowiak and colleagues found that 53% of children with ASD between the 
ages of 2 and 5 years had at least one sleep problem compared to 32% of typically 
developing children.
 
Peak onset of sleep problems among children with ASD is during the second year of life. 
Sleep problems often last for many years and sometimes continue into adulthood. In one study, 
over 50% of children with autism report at least one sleep problem, with a peak onset during the 
second year of life. In another study, 63% of children with ASD and sleep problems experienced 
persistence of sleep difficulties over time.
 
Sleep problems interfere with developmental progression and exacerbate problems in 
daily adaptive function for children with autism. Parents of poorly sleeping children with ASD 
routinely report worse daytime behavior following nights of fragmented or insufficient 
sleep. Studies have demonstrated that short sleep duration was associated with social skills 
deficits, stereotypic behavior, and increased overall autism scores.
 
Sleep problems are associated with higher ratings of caregiver stress. Sleep problems were 
reported by almost 70% of 210 Hong Kong families with a young child with ASD. Severity of sleep 
problems predicted parental stress in these children. Sleep maintenance difficulties in children 
with ASD have a significant impact on parental sleep. A recent study by Meltzer reported poorer 
sleep quality and shorter total sleep time among parents of children with autism compared to 
parents of typically developing children.
 
Behavioral sleep treatments are known to improve sleep among preschool 
aged children. Behavioral interventions like graduated extinction, scheduled nocturnal 
awakenings, and bedroom passes can be utilized to set appropriate behavioral limits at bedtime 
and to promote the development of more adaptive self-soothing skills. Sleep hygiene and 
behavioral therapy have demonstrated effectiveness of behavioral interventions for sleep onset 
and maintenance problems in children with ASD.
 
There are few providers with expertise in behavioral sleep treatments, which limits access to 
care, especially for children with ASD. There are only 412 registered providers for behavioral 
sleep interventions in the U.S. (for all ages). Very few of those providers are qualified to treat 
children, and even fewer have training working with children with ASD. The relatively large 
numbers of children with ASD and sleep problems cannot realistically be effectively treated using 
an in-person treatment model; thus, a new approach is needed that does not require direct 
access to highly trained providers.
 
mHealth interventions can address significant barriers to treatment access and have 
demonstrated effectiveness. Current barriers to receiving sleep/behavioral health care include 
limited availability of qualified providers, long wait time when providers are identified, 
geographically inconvenience, and necessity for missed work or school. An mHealth intervention 
for parents of children with ASD could help address these significant barriers. Moreover, there is 
evidence of effectiveness for parent targeted mHealth interventions for improving child sleep.
 
The Sleep Committee of the Autism Treatment Network (ATN) recently concluded that evidence-
based standards for the behavioral, pharmacologic, and other treatments of insomnia in ASD are 
not yet available. There are 2 primary reasons that existing sleep interventions need to be 
specially tailored for children with ASD.
 
First, sleep problems among children with ASD are highly heterogenous. Sleep onset and 
maintenance problems resulting in reduced sleep duration are the most common concerns 
expressed by the parents of children with ASD. Circadian rhythm disturbances have also been 
reported in children with ASD, including irregular sleep–wake patterns, free running sleep/wake 
rhythms, sleep onset delay and early morning awakening have been reported in children with 
autism. The heterogeneity of sleep difficulties points to the necessity of developing a modularized 
treatment, as has been used previously.

 
Second, there is considerable heterogeneity in learning styles amongst individual with ASD, 
necessitating multiple and flexible approaches to behavioral treatment strategies. SweetDreams 
incorporates the evidence-based practices of TEACCH, including 1) the importance of clearly 
defined physical boundaries for spaces that serve difference purposes; 2) having a consistent 
schedule visualized through drawings and photographs; 3) routine is essential because the one of 
the most important functional support systems for autistic individuals is consistency; and, 4) 
visual structure involves visually-based cues for reminders and instruction.
7.5  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
Utilizing the method proposed for the present project and described in phase 1, Dr. Asarnow 
developed BrightMobile, a mHealth adaptation of evidence-based sleep health interventions for 
teens. BrightMobile was developed and pre-tested within a one year period. BrightMobile is now 
being tested in a primary care practice that primarily serves MediCal patients. 22 youth (M age 
15, 95% minority), recruited from primary care over a 6-month period, independently provided 
feedback on the BrightMobile video content and delivery. Quantitative prepost data indicate a 
significant improvement in both sleep quality and depression symptoms.
7.6  
Is this a treatment study, i.e. does this study intend to provide treatment 
* TREATMENT PROTOCOL: 
to individuals with a medical or psychological condition: (REQUIRED)
 Yes  
 No
7.7  
 Does this study involve any procedures, lab tests or imaging studies that 
* BILLABLE PROCEDURES:
have a CPT code and could be billable to patients, their insurance, Medi-Cal, Medicare, or any other 
entity (answer 'Yes' even if the study is going to pay for all the procedures): (REQUIRED)
  Yes  
  No
, send 
If you are not sure if your study involves billable procedures
an email to the 
 for help 
UCSF Office of Clinical Research (OCR)
answering this question.
7.8  
Types of research activities that will be carried out. Check all that 
 COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Social media-based research activities
Observation
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, 
etc.)
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-
guided biopsies, DEXA scans, MUGA or PET scan)
Administration of contrast agent
Randomization to one intervention versus another
Use of placebo
Biopsy conducted solely for research purposes
Sham surgical procedure
None of the above

1.  
2.  
7.9  
PROCEDURES / METHODS: 
* 
(REQUIRED)
Describe the research methods and study activities taking place at each site 
(e.g. what will participants be asked to do and what will members of the 
study team do?). If there will be multiple participant groups or study sites, 
explain what will happen with each group or study sites.
 
If some of the activities would occur even if the person were not in the 
study, as in the case of treatment or tests performed for diagnostic 
purposes, clearly differentiate between those activities that will be 
done solely for research purposes and those that are happening as 
part of routine care.
 
Please call our office at 415-476-1814 and ask to speak to someone on the 
Expedited Review team if you need help differentiating between what parts 
are research and what parts aren't.
To be included in the study, children must a) have poor sleep health defined by the Children’s 
Sleep Habit Questionnaire (scoring 41 or higher); and, b) have a diagnosis of ASD. Exclusion 
criteria are: 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).
 
Phase I begins with the development and refinement of SweetDreams. Phase I involves 2 distinct 
stages as described below and uses an iterative intervention development process (N=10).
Development of SweetDreams (months 1-3): Dr. Lauren Asarnow at UCSF will develop 
SweetDreams for the purpose of this research study, which will provide preliminary data 
for a larger scale effectiveness trial. SweetDreams. will adapt existing evidence based 
sleep interventions to address the most common sleep disturbances among children with 
ASD (difficulties initiating or maintaining sleep, circadian dysregulation, and bedtime 
resistance1) for a mobile health delivery platform. This phase features refining and 
adapting the SweetDreams manual into distinct learning modules. Learning modules are 
designed for parents and will feature interactive animated videos; these are elements that 
research indicates promotes utilization and retention of content learned. The team will 
work with an animator to develop the video content. The mobile delivery will be conducted 
via Twilio on REDCAP. Worksheets that help apply the didactic content from the videos to 
the child will also be delivered via REDCAP. We will receive no data from VImeo or 
Twilio: we will only receive a timestamp for when the participant opens the REDCap 
questionnaire containing the video and when they mark it as complete.
Pre-Test (months 3-8): We will pre-test the intervention with 5 children and their 
parents. Parents will be asked to participate in the intervention, which provides parents 
with behavioral skill training that they will ideally implement with their children every day, 
and they will be asked to complete post-treatment qualitative (interview) and quantitative 
(Credibility Expectancy Questionnaire; CEQ34) assessments regarding intervention 
usability, acceptability, and outcomes. Post-treatment qualitative interviews will be 
recorded. Audio files will be stored in an encrypted folder and transcribed after data 
collection is complete. Audio files will be destroyed upon completion of data analysis. No 
other assessments will take place in Phase I. The goals are to (1) streamline 
screening and recruitment materials; (2) use feedback to ensure SweetDreams is user 
friendly and developmentally appropriate; (3) solicit feedback from the participating 
parents to be reviewed with the research team (Drs. Asarnow, Bush and Leventhal). This 
process will involve extensive collaboration with parents. This approach is in line with the 
emphasis by NIH that collaboration can “develop more effective interventions…by 
targeting interventions to the identified needs of community members.” Here, we 
anticipate two key benefits: the research team can learn from the parents about how their 
daily habits and experiences within their families affect their child’s sleep. The intervention 
will be refined based on feedback from parents, that will then be reviewed by Drs. 
Asarnow, Bush and Leventhal. We will pre-test the refined intervention with 5 children 
and their parents. After review of new data, the intervention will be refined as needed. We 
expect this will be sufficient for Phase 1 intervention development, but will conduct 
additional piloting if needed.
 
Phase II consists of the pilot feasibility RCT. In the second phase (months 8–12) we will conduct a 
small pilot, randomized, controlled trial to establish the basis for proposing a larger scale 

1.  
2.  
3.  
intervention study. The RCT will be conducted with children (aged 12-60 months) with ASD and 
sleep problems (N = 20) who will be randomized to one of two groups: (a) SweetDreams (n = 
10) or (b) wait-list control (n = 10).
Recruitment and Screening: Children and their parent(s) will be recruited from the STAR 
Autism Clinic and the Division of Developmental Medicine. Eligible families will be given an 
information sheet describing the study when registering for their appointment. If families 
are interested in the study, they will be consented and asked to complete an initial 
screening measure. Families who screen positive for sleep problems will be scheduled for a 
telephone screening to determine if all eligibility criteria are met. Eligible participants will 
then be scheduled to complete a baseline assessment and randomization.
Baseline Assessment: Eligible children and their parents will attend a baseline 
assessment measure collection via telephone/Zoom. At the end of the baseline 
assessment, families will be randomized to either SweetDreams or the waitlist control 
condition. All assessment staff will be blind to treatment condition. If a family 
is randomized to receive the SweetDreams, a separate research assistant (RA) not 
involved in assessments will orient the parents to the treatment. The parent will complete 
the baseline learning modules of the program and be given an opportunity to set goals and 
ask any questions they have about the program.
Post-Treatment Assessments: Post-Treatment assessments will be conducted via telephone
/Zoom. Following the Post-Treatment assessment, families who were in the wait-list 
control condition previously will be oriented to SweetDreams. The parent will complete the 
baseline learning modules of the program and be given an opportunity to set goals and 
ask any questions they have about the program. An additional Post-Treatment assessment 
will be conducted for wait-list control participants at the end of their treatment course. 
Apart from Screening, Baseline, and Post-Treatment Assessments, no other assessments 
will take place. 
 
The SweetDreams Intervention will be structured as follows:
Four core modules will be delivered to all families in a prescribed order. The participants' 
responses to the CSHQ assessment at baseline will dictate which sleep problems they report and 
which optional modules will be assigned.
Baseline. Core Module. a)
The frequency, 
 Self-assessment, case formulation, and goal setting. 
intensity and duration of symptoms covering the periods before bed, during the night, shortly 
after waking and during the day. Goals are identified and operationalized. b) 
R
Basic behaviorism. 
eview basic behavioral learning in order to promote behavioral change. Parents develop a menu 
of skills to extinguish and/or promote behaviors. 
Week 1. Core Module. a) 
 Education about the 
Establishing bedtime and naptime routine.
importance of routine both for ASD and for building positive sleep associations. 
Develop consistent schedule visualized through drawings and photographs. b) Establishing 
. Discussion of basic sleep and circadian science and the 
Regular-Sleep Wake Schedules
importance of maintaining regularity in sleep schedule (including on weekends). Discuss common 
obstacles to adherence. 
Week 2. Core Module. Limit Setting & Positive Reinforcement.
 
 We build the motivation for parents 
to begin to set limits around sleep. Review the importance of consistency and the power of 
positive reinforcement to create behavior change. Create a visual structure involving visually-
based cues for reminders and instruction on set limits. Create clearly defined physical boundaries 
for sleep space. 
Week 3. Optional Modules (families will get assigned modules a through d based on CSHQ 
assessment): a) 
Develop a list of strategies to help parents support their 
Calm Down Strategies. 
child to calm down when they get agitated or excited before bed or in the middle of the night. 
Emphasis is on developing self-soothing strategies for children. Strategies including breathing 
techniques, listening to an audiobook, bean bag press, or hugging a stuffed animal; b) Managing 
. Develops strategies for parents to manage children waking in the 
Middle of the Night Awakenings
middle of the night; c) 
 Develops strategies for parents to 
Managing Early Morning Awakenings.
manage children’s early morning awakenings. Discusses circadian cues that can be emphasized; 
and, d) 
 Develops strategies for parents to manage children who keep 
Managing Curtain Calls.
getting out of their bed after being put to bed. 
Week 4. Core Module. 
The goal is to consolidate gains and prepare for 
Relapse prevention. 
setbacks.
7.10  
: To what extent, if any, do the planned research procedures differ 
STANDARD CLINICAL PRACTICE

from the care that people would otherwise receive at this institution or the study site if not being 
done locally:
 
Behavioral interventions like graduated extinction, scheduled nocturnal awakenings, and bedroom 
passes can be utilized to set appropriate behavioral limits at bedtime and to promote the 
development of more adaptive self-soothing skills. Sleep hygiene and behavioral therapy have 
demonstrated effectiveness of behavioral interventions for sleep onset and maintenance problems 
in children with ASD. However, there are only 412 registered providers for behavioral sleep 
interventions in the U.S. (for all ages). Very few of those are qualified to treat children, and even 
fewer have training working with children with ASD. The relatively large numbers of children with 
ASD and sleep problems cannot realistically be effectively treated using an in-person treatment 
model; thus, a new approach is needed that does not require direct access to highly trained 
providers.
The Sleep Committee of the Autism Treatment Network (ATN) recently concluded that evidence-
based standards for the behavioral, pharmacologic, and other treatments of insomnia in ASD are 
not yet available. 
7.11  
List all questionnaires, surveys, interview, or focus group guides that will be used for 
INSTRUMENTS: 
this study:
If the instruments are not complete or not available because they will be 
developed as part of this study, describe the basic content or include an 
outline and submit the final versions to the IRB with a modification for 
approval prior to use.
Children’s Sleep Habits Questionnaire (CSHQ)
Pittsburgh Sleep Quality Index (PSQI)
Vineland Adaptive Behavior Scales (VABS) -- Parent/Caregiver Interview Form
Perceived Stress Scale (PSS)
Caregiver Strain Questionnaire (CGSQ)
General Functioning Scale (GFS)
Contact Form & Demographics
Compensation Form
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after 
completing the study application. Published instruments should 
NOT be attached.
7.12  
Are you drawing any blood or collecting other biosamples (e.g. tissue, 
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.) for analysis under this protocol and/or storage for future 
research: (REQUIRED)
  Yes  
  No
7.13  
Briefly summarize the methods and types of analyses that will be 
STATISTICAL METHODS: 
performed:

Statistical Analyses will be conducted for Phase II. Descriptive analyses (e.g., mean, 
standard deviation, skewness) will be conducted for all variables of interest. For 
dependent variables of interest, distributions will be tested for normality and for homogeneity of 
variances across groups. If necessary, we will log transform the data to approximate a normal 
distribution. Provided that the data meet necessary requirements for employing parametric 
analyses, primary hypothesis testing for the proposed study will rely on repeated measures 
ANOVA (with time as the repeated factor with 2 levels; baseline and post-treatment) 
to investigate a time by treatment group interaction. We will use SPSS to conduct these analyses. 
We expect to be underpowered to detect effects but will use the mean differences to inform pilot 
data for larger grant.
7.14  
List only the 5-10 most relevant references (a separate bibliography can be attached 
REFERENCES: 
 
for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with):
1. Malow BA, Marzec ML, McGrew SG, Wang L, Henderson LM, Stone WL. Characterizing sleep 
in children with autism spectrum disorders: a multidimensional approach. Sleep. 2006;29(12):
1563-1571.
2. Souders MC, Mason TB, Valladares O, et al. Sleep behaviors and sleep quality in children with 
autism spectrum disorders. Sleep. 2009;32(12):1566-1578.
3. Giannotti F, Cortesi F, Cerquiglini A, et al. An investigation of sleep characteristics, EEG 
abnormalities and epilepsy in developmentally regressed and non-regressed children with autism. 
Journal of autism and developmental disorders. 2008;38(10):1888-1897.
4. Wiggs L, Stores G. Sleep patterns and sleep disorders in children with autistic spectrum 
disorders: insights using parent report and actigraphy. Dev Med Child Neurol. 2004;46(6):372-
380.
5. Mindell JA, Du Mond CE, Sadeh A, Telofski LS, Kulkarni N, Gunn E. Efficacy of an internet-
based intervention for infant and toddler sleep disturbances. Sleep. 2011;34(4):451 458.
6. Wiggs L, France K. Behavioural treatments for sleep problems in children and adolescents 
with physical illness, psychological problems or intellectual disabilities. Sleep 
Medicine Reviews. 2000;4(3):299-314.
7. Giannotti F, Cortesi F, Cerquiglini A, Bernabei P. An open-label study of controlled-release 
melatonin in treatment of sleep disorders in children with autism. J Autism Dev Disord. 2006;36
(6):741-752.
8. Malow BA, Adkins KW, Reynolds A, et al. Parent-based sleep education for children with 
autism spectrum disorders. J Autism Dev Disord. 2014;44(1):216-228.
9. Reed HE, McGrew SG, Artibee K, et al. Parent-based sleep education workshops in autism. J 
Child Neurol. 2009;24(8):936-945.
10. Meltzer LJ. Brief report: sleep in parents of children with autism spectrum disorders. J Pediatr 
Psychol. 2008;33(4):380-386.
8.0
 Drugs and Devices
8.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
  Yes  
  No
If you have questions about FDA requirements for drug or device 
research, you can send an 
to request a consult.
email 
8.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
 Yes  
 No
If you have questions about FDA requirements for drug or device 
research, you can send an email to request a consult.

8.4  
 
 Are you requesting a Non-Significant Risk (NSR) determination for an investigational device: 
* NSR:
  
(REQUIRED)  Note: an 
 is different from an Investigational Device Exemption 
NSR determination
(IDE). Check the Help link for more guidance on what types of devices can qualify for an NSR 
 
determination.
 Yes  
 No
Explain why the use of the device in this study poses a non-significant 
* 
risk: (REQUIRED)
The devices do not meet the criteria for "significant" risk as listed above. The device is 1) not an 
implant, 2) will not supporting or sustaining human life, and 3) while it does help treat disease, it 
does NOT present a potential for serious risk to the health, safety, or welfare of a subject.
 
SweetDreams, an adaptation of existing evidence-based sleep interventions, is a user friendly and 
developmentally appropriate modularized 4-week web-based intervention; it is available on 
computer, tablet or mobile phones. It has three main components 1) didactic content via 
animated video learning modules, no longer than 7 minutes each, totaling 20 minutes per week 
(a link to the videos will be sent at the collaboratively predetermined time(s) via text message), 
2) digital worksheets to personalize the recommendations that are discussed in the learning 
modules (requiring up to 10 minutes for completion), and 3) weekly telephone support (provided 
by Dr. Asarnow). Video learning modules will be hosted on password protected Vimeo™ platform 
using a unique password to enable usage monitoring.
Attach any documentation you have from the manufacturer and/or 
FDA to support this determination.
8.5  
List the medical devices or in vitro diagnostics to be studied or used. In the device 
LIST THE DEVICES: 
details screen you will be asked questions such as:
Whether the device is FDA approved or investigational
Medicare device category
If the device will be provided at no cost
If an IDE is necessary, the IDE number, and who holds the IDE
Risk category of the device
FDA status of the device
Please see the 
 for more details about the use of devices in research, including the 
UCSF IRB website
  
Investigator Checklist for Significant Risk, Non-Significant Risk, and/or IDE Exempt Device Studies  
 If the sponsor’s protocol does not list the IDE number, you must submit 
Verification of IDE numbers:
documentation from the sponsor or FDA identifying the IDE number for this study. Attach this 
  
documentation in the Other Study Documents section of the Initial Review Submission Packet.  If 
you have any correspondence from the FDA or sponsor regarding this device, 
 
please attach it to the application.  
View 
Details
Device Name
Is the Device 
FDA Approved
Is this a new 
device or a new 
use of an already 
approved device
IDE Number
SweetDreams 
No 
Yes 
 
Manufacturer/Supplier of 
Device
Principal Investigator 
Medicare Category
A
B
Where will the Devices Be 
Stored
 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 

HDE Number
 
Is the Device FDA Approved
No 
Is this a new device or a new 
use of an already approved 
device
Yes  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE details
 
In the opinion of the sponsor, 
select the level of risk 
associated with this device
No Significant Risk  
8.6  
Is this an expanded access or compassionate use protocol, meaning the 
* EXPANDED ACCESS: 
primary purpose is to diagnose, monitor or treat a patient's condition, rather than the collection of 
safety and efficacy data of the experimental agent: (REQUIRED)
  Yes  
  No
9.0
 Sample Size and Eligibility Criteria
9.1  
 
How many people will you enroll:
ENROLLMENT TARGET: 
30
 If there are multiple participant groups, indicate how many people will be 
in each group:
For Phase I, we will recruit 10 children and their parents as part of the iterative intervention 
development process. For Phase II, we will conduct a small pilot randomized controlled trial with 
20 children and their parents who will be randomized to one of two groups: (a) SweetDreams (n 
= 10) or (b) wait-list control (n = 10).
9.3  
Explain how and why the number of people was chosen. For multi-site 
SAMPLE SIZE JUSTIFICATION: 
studies, this is referring to the number that will be enrolled across all sites:
All design decisions are guided by our overarching aim to promote future scalability to a 
population of children with ASD in clinics in community settings.
9.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
9.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)
Inpatients
Outpatients

Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above
9.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)
Children / Minors
Adult subjects unable to consent for themselves
Adult subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
If not already addressed in the Background and Significance questions in 
the Research Plan section or elsewhere, explain why it is appropriate to 
include the types of subjects checked above in this particular study:
The study is designed to improve the care of a special vulnerable population -- minors diagnosed 
with Autism Spectrum Disorder. We believe that a non-pharmacological sleep intervention is safe 
and likely effective and may have benefits that extend beyond sleep, including improving the 
behavioral, cognitive and social functioning of children with ASD, as well as the mental health and 
wellbeing of their caregivers.
Describe the additional safeguards that have been included in the study to 
protect the rights and welfare of these subjects and minimize coercion or 
undue influence:
Here are some examples:
evaluating capacity to consent for individuals who may be decisionally 
impaired (specify how)
calibrating payment amounts to be non-coercive for the financially 
disadvantaged
conducting more in-depth evaluations of subjects’ understanding of 
the study and the voluntary nature of participation
involving advocates in the consent process
More information and other safeguards are described here: Vulnerable 
 and 
.
Subject Populations
Recruiting Staff and Students
The study intervention is delivered within the context of usual care services in the STAR clinic and 
the researchers will be able to refer to treatment providers as needed. Informed consent will 
clearly indicate the limits of confidentiality and that confidentiality may need to be broken if there 
is a safety concern.
9.7  
 Briefly describe the population(s) that will be involved in this study. Include 
INCLUSION CRITERIA: 

anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, providers, 
administrators, students, parents, family members, etc.):
a) Age 12-72 months;
b) Poor sleep health defined by the Children’s Sleep Habit Questionnaire (scoring 41 or higher);
c) A diagnosis of ASD;
d) Access to internet via computer, tablet, or smartphone
9.8  
 List any exclusion criteria (e.g. reasons why someone would not be included in 
EXCLUSION CRITERIA:
the study):
a) Any regular sleep medication use (this does not include occasional over the counter sleep aid); 
and
b) Known sleep apnea, unstable major medical conditions (e.g. severe asthma, diabetes which is 
not managed)
9.9  
Do any study activities take place on any patient 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
care units including inpatient wards, peri- or post-operative care units, operating rooms, or in the 
 
Emergency Department at UCSF Health medical facilities: (REQUIRED)
  Yes  
  No
9.11  
Does your protocol or study involve any of the following patient related 
EMERGENCY DEPARTMENT: 
* 
activities in the emergency department (e.g. subject identification, recruitment, consent, blood 
draws, specimen retrieval, involvement of ED staff (nursing, tech, and/or physician), or any other ED 
based procedures): (REQUIRED)
 
  Yes  
  No
10.0
 Inclusion of Minors in Research
10.1  
Select all the 
 that apply:
REGULATORY CATEGORIES OF RESEARCH: 
regulatory categories
No greater than minimal risk (45 CFR 46.404, 21 CFR 50.51)
Greater than minimal risk but presenting prospect of direct benefit (45 CFR 46.405, 21 CFR 
50.52)
Greater than minimal risk (though only a minor increase over minimal risk) and no prospect 
of direct benefit but likely to yield generalizable knowledge about the subjects disorder or 
condition (45 CFR 46.406, 21 CFR 50.53)
Research not otherwise approvable which presents an opportunity to understand, prevent, or 
alleviate a serious problem affecting the health or welfare of children (45 CFR 46.407, 21 CFR 
50.54)
Explain why the research in this study falls under the above category or 
categories:
We believe that the risks associated with this study are minimal compared to the knowledge that 
will be gained. Informed consent will clearly indicate the limits of confidentiality and that 
confidentiality may need to be broken if there is a safety concern.

10.2  MINORS CONSENTING: Will this study enroll minors who can 
 (as in 
legally consent for themselves
the case of emancipated minors or minors being treated for pregnancy or drug use without their 
parents knowing). This is different from agreeing to be in the study even when their parents are the 
ones providing 'official' consent, which we refer to as 'providing assent':
Note: This is very rare and the answer is usually 'No.'
  Yes  
  No
10.3  
PARENTAL PERMISSION VS. WAIVER: Please review the 
 to see under what circumstances 
guidance
the IRB can waive parental permission.
Parental permission will be obtained
Waiver of parental permission is requested: The waiver meets the provisions for a waiver of 
consent (i.e., the research poses minimal risk, it could not practicably be carried out without 
the waiver of parental permission, AND the waiver will not adversely affect the rights and 
welfare of the minor participants (45 CFR 46.116(d))
Waiver of parental permission is requested: Parental permission is not a reasonable 
requirement to protect the minor (e.g. neglected or abused children) or parental knowledge 
of the study may endanger the health or welfare of the minor (45 CRF 46.408(c))
Provide details on the other protections that will be in place:
i) Parental consent will be obtained by a TRAINED research assistant.
ii) Consent will be obtained in person at the study research space or at a private space in the 
clinic.
iii) There is no limit to the time allowed for discussion of consent. This process varies by subject. 
It is expected that most subjects will be able to reach a decision within 15 to 20 minutes.
vi) To minimize coercion, all subjects will be encouraged to ask questions and strongly 
discouraged from signing the consent without carefully reading it.
The person obtaining consent will go over the consent with the participant/parent, frequently 
pausing to inquire if the participant/parent understands or has questions. People who are not 
fluent in English enough to understand the consent or complete study interviews and 
questionnaires will not be enrolled. People with hearing impairment severe enough to prevent 
meaningful participation in therapy will be excluded. If level of impairment is minimal and 
participation is possible, the person obtaining consent will speak loud and slow and will ensure 
that the subject has not missed any information.
10.4  
 Please review the 
 to see under what circumstances the 
ASSENT OF MINORS OR WAIVER:
guidance
IRB can waive assent.
Assent of children developmentally and psychologically able to provide assent will be obtained
Waiver of assent is requested: The capability of some or all of the children is so limited that 
they cannot reasonably be consulted
Waiver of assent is requested: The research holds out a prospect of direct benefit that is 
important to the health or well-being of the children and is available only in the context of the 
research
Waiver of assent is requested: The activities involving the minor are limited to chart review or 
the something equally innocuous
Waiver of assent is requested: It is not culturally appropriate to involve the minor in the 
decision to participate (e.g. some foreign research)
Provide a brief justification for the waiver:
Children will be between 12-72 months and diagnosed with Autism Spectrum Disorder. 

10.5  
(select all that will be used):
DOCUMENTATION OF PERMISSION AND ASSENT: 
Permission form addressed to the parents
Simplified assent form addressed to the child, 7-12 years old (parents get separate form)
Assent form addressed to the child, 13 years and older (for subjects and parents)
Assent form addressed to the child, 13 years and older (parents get separate form)
Check one:
One parent's signature will be obtained 
Two parents' signatures will be obtained 
If this study is approvable under regulatory category .405 and you plan to get permission from 
only one parent, explain why you think one parent's permission is sufficient:
10.6  
Might this study enroll wards of the state:
WARDS OF THE STATE: 
  Yes  
  No
11.0
 Recruitment and Consent
11.1  
Is this a competitive enrollment clinical trial? By competitive 
* COMPETITIVE ENROLLMENT: 
enrollment, we mean that sites who do not enroll participants early may not get to participate at all: 
(REQUIRED)  
  Yes  
  No
11.2  
 
What kinds of methods will be used to identify potential 
* SUBJECT IDENTIFICATION METHODS: 
participants for recruitment (check all that apply): (REQUIRED)
Review of patients' conditions, history, test results, etc. (includes patients seen in clinic, 
scheduled for surgery, a procedure, imaging, or tests, or seen in the Emergency Department 
as well as searching through medical record data for possible cohort identification)
Already approved recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials 
you will provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social 
media, presentation of the study at community events/media, etc.)
Online recruiting tool (describe below)
CTSI Recruitment Services unit
Posting on UCSF Clinical Trials, ClinicalTrials.gov or other publicly available clinical trial website
Other method (describe below)
Attach your recruitment materials (e.g., flyers, ads, recruitment 
letter templates, email text, etc.) in the Other Study Documents 
section of the Initial Review Submission Packet Form.
* Provide details about the subject identification methods: (REQUIRED)
Children and their parent(s) will be recruited from the STAR Autism Clinic and the Division of 
Developmental Medicine. Eligible families will be given an information sheet describing the study 
when registering for their appointment. If families are interested in the study, they will be 
consented and asked to complete an initial screening measure. Families whose child screens 

positive for sleep problems will be scheduled for a telephone screening to determine if all 
eligibility criteria are met. Eligible participants will then be scheduled for a baseline assessment 
and randomization.
Children and their parent(s) will also be recruited throughout the community, from recruitment 
ads posted on sources like online parents networks, county resource centers, etc. Recruitment 
ads will contain the study phone number, which interested parents can call to learn more about 
the study and determine eligibility. 
Additionally, we will utilize SPARK's research match program for participant recruitment.
11.4  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
determined:
Children and their parent(s) visiting the STAR Autism Clinic will be given a contact sheet with 
information regarding the study when registering for their appointment. If interested, parents will 
complete the initial pre-screening questionnaire (Children’s Sleep Habits Questionnaire 
(CSHQ), internet/mobile phone access, and English fluency) either via RedCap or a phone call. 
Eligible children and parents will be scheduled for consent and a screening interview to rule out 
exclusion criteria; we will use screening questions assessing current medication use, known sleep 
apnea, and unstable major medical conditions. Eligible children and parents will then participate 
in a baseline assessment and begin treatment. A research assistant (RA) will conduct all 
assessments (baseline, post-treatment and follow-up) using a combination of 
telephone interviews and online questionnaires. At the end of the baseline assessment, 
participants will be randomized to either the SweetDreams intervention condition or the waitlist 
control condition. If a family is randomized to receive the SweetDreams intervention, a research 
assistant (RA) will orient the parents to the treatment.
11.5  
Who initiates contact (check all that apply): 
INITIATION OF CONTACT: 
* 
(REQUIRED)
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
11.6  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)
Attach the telephone recruitment script in the Other Study 
Documents section of the Initial Review Submission Packet Form. If 
potential participants will initiate contact, attach the telephone 
screening script that will be used to provide more information about 
the study and determine if callers are eligible to participate.
11.7  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)

Participants will be recruited from the STAR Autism Clinic and the Division of Developmental 
Medicine,. When parents register for their visits, they will be sent a contact sheet with information 
about the project. The contact sheet will explain that UCSF researchers are conducting a study on 
sleep for children with ASD. If interested and willing to speak with the research assistant (RA), 
the parent will complete a contact form. The RA will contact the parent to discuss the study within 
2 business days. The RA will explain the study and conduct a phone screen to determine 
basic eligibility. Once a family is pre-screened and deemed eligible to continue, the RA will 
schedule a consent and screening interview visit. There, the RA will obtain consent from 
parents and the RA will cover the informed consent information thoroughly and answer any 
questions about the study. The signature of these forms will be gathered via docusign. 
Children and their parent(s) will also be recruited throughout the community, from recruitment 
ads posted on sources like online parents networks, county resource centers, etc. Recruitment 
ads will contain the study phone number, which interested parents can call to learn more about 
the study and determine eligibility. 
Additionally, we will utilize SPARK's research match program for participant recruitment.
11.8  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)
Sign a paper consent form at the end of the consent discussion (signed consent)
Sign an electronic consent form using DocuSign (signed consent)
Provide online consent through an app, a website, or a survey tool such as Qualtrics or 
REDCap (waiver of signed consent)
Be told about the study and be given a handout/information sheet and be asked if they agree 
to participate (verbal consent - waiver of signed consent)
Complete the study activities and turn in materials, as in the case of a completed survey that 
is placed in a drop box or mailed to the study team (implied consent - waiver of signed 
consent)
Not be able to provide consent and will have a family member consent for them, as in the 
case of a critically ill or unconscious patient (surrogate consent)
Not be able to provide consent (emergency waiver of consent - allowed for minimal risk 
research or greater than minimal risk research with an approved community consultation plan)
Not know about the study, as in the case of chart reviews or observations of public behavior 
(waiver of consent)
Other method (describe below)
As of Winter 2020, the UCSF Version of DocuSign is not Part 11 
compliant. Part 11 compliance is required for FDA-regulated studies 
(studies using of investigational drugs or devices or studies of 
approved drugs or devices for investigational use). UCSF is 
currently pursuing a Part 11-compliant version of DocuSign. Please 
check the 
webpage for updated 
UCSF 21 CFR Part 11 Compliance 
information about the availability of Part 11-compliant DocuSign at 
UCSF.
11.9  
Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study: (REQUIRED)   We encourage researchers to review our 
.
guidance on obtaining and documenting informed consent
If there are multiple groups being consented differently, provide details about the consent 
process for each group.
If you are relying on 
, provide details about how that will happen.
verbal or implied consent
For studies using online recruitment and consent or consent via mail, provide details here.

Consent will be obtained by a TRAINED research assistant who will go over the consent form with 
the participant via telephone/Zoom. Consent will be obtained via docusign. There is no limit to 
the time allowed for discussion of the consent. This process varies by subject. It is expected 
that most subjects will be able to reach a decision within 15 to 20 minutes. To minimize coercion, 
all subjects will be encouraged to ask questions and strongly discouraged from signing the 
consent without carefully reading it.
 It is important that the people obtaining consent are qualified to do so. 
*
Briefly describe the training and experience these individuals have in 
obtaining informed consent: (REQUIRED)
The Research Assistant will complete CITI training and will be trained personally by the 
Principal Investigator to ensure that all study protocols are understood and followed. In the first 
few months of the study the research assistant will shadow the PI while we develop a manual of 
operations, and recruitment protocol procedures. Following the first few months the research 
assistant will take primary responsibility for the study and will continue to meet with the PI once 
a week (at minimum) to ensure that the study protocol is being followed.
11.10  
Indicate how the study team will assess and enhance the subjects' 
CONSENT COMPREHENSION: 
* 
understanding of study procedures, risks, and benefits prior to signing the consent form (check all 
that apply): (REQUIRED)   Tip: Review the Consent Comprehension - Learning Notes in the Help 
bubble at the right for specific questions that can be asked to assess comprehension, consider 
using the UCSF Decision-Making Capacity Assesment Tool, and review our guidance on obtaining 
written or verbal informed consent for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended 
questions about the nature of the study or the experimental treatment, the risks and benefits 
of participating, and the voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their 
understanding of the study purpose, procedures, risks and benefits, as well as the voluntary 
nature of participation (especially appropriate when the consent process happens online or 
through a mobile health app)
Other method (describe below):
Provide details of the other approaches that will be used, if using another 
method to assess comprehension:
11.11  
Does this study rely on some deception or misinformation about what the 
* DECEPTION: 
researchers are observing to get valid data? (REQUIRED)
  Yes  
  No
11.14  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
(i) Screening time: Pre-Screen 15 minutes AND Screening Interview 15 minutes
(ii) Active participation in the study:
60 minutes for post-treatment follow-up (Phase I) OR 30 minutes each for baseline 
and post-treatment follow-up assessment (Phase II),
120 minutes of active treatment time
(total of 210 minutes, or 3.5 hours)
 
It is anticipated that participants in both phases of the study will have similar time commitments.
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.

11.15  
Is there a standard of care (SOC) or usual care that would be offered 
ALTERNATIVES: 
to prospective participants at UCSF (or the study site) if they did not participate in this research 
study:
  Yes  
  No
11.16  
Is the study drug or treatment available off-study:
OFF-STUDY TREATMENT: 
Yes 
No  
Not applicable 
11.17  
Describe other alternatives to study participation, if any, that are available 
OTHER ALTERNATIVES: 
to prospective subjects:
Alternative to online and in-person sleep treatment such as the SweetDreams Intervention is the 
use of hypnotic medications. However, to the best of our knowledge there are no data indicating 
that this alternative is superior to study interventions among children with Autism Spectrum 
Disorder.
12.0
 Risks and Benefits
12.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 
to participants that may need to be disclosed in the consent form:
Physical discomforts or pain
Risks to employment, or social or legal standing
Risk that the study team may observe possible evidence of child abuse, elder abuse, or a 
threat to self or others that they are required to report
12.2  
Describe any anticipated risks and discomforts not listed above: 
RISKS: 
* 
(REQUIRED)
Risks associated with other procedures involved in the study as part of the data collection 
and measurement involve minimal risk. These include (a) the potential for loss of privacy and 
confidentiality; (b) legal limits to the confidentiality of information obtained if risk of harm to self 
or others, including children, is disclosed (in our experience, this has been very rare); and (c) 
some participants may consider the study measures timeconsuming, inconvenient, or otherwise 
disruptive of their usual routines. Time taken to attend study visits could also pose economic 
hardship. Subject payment are designed to offset this burden.
Another risk is associated with randomization. Subjects will be assigned to the treatment group or 
waitlist control group by chance, and it is possible that, if the treatment is effective, participants 
in the waitlist control group may experience a delay in improvement.
12.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation

Minimizing inconvenience: We try to minimize participant burden by offering participants the 
option to complete study measures online at their convenience, whenever feasible and 
assessments over the phone or zoom. In addition, efforts will be made to reduce inconvenience to 
participants by scheduling assessment and treatment sessions at times that are most convenient 
to them.
 
Minimizing risks of confidentiality: Protection of confidentiality will be accomplished by 1) 
assigning each participant a unique research ID that is not related to their PHI; 2) using HIPAA 
compliant school of medicine secure servers and encrypted and password protected computers for 
data collected and storage; 3) allowing access to any participant data only to authorized project 
staff that need to have access. No data will be extracted from the video platform. Participant data 
(questionnaires, worksheet responses, etc.) will be collected through REDCap.
 
For those individuals who are recruited via SFARI research match, participants will be asked 
to consent for the SPARK study, hosted by the Simons Foundation, to share with the University of 
California, San Francisco the clinical, demographic and genetic data collected during their 
participation in SPARK. Likewise, participants will be asked for consent to share the data collected 
during the study here at the University of California, San Francisco with SPARK in order to add to 
the information that was collected during your participation in SPARK. To safeguard 
confidentiality, all data-sharing will occur via a secure transfer system, and access to identifiable 
data will be limited to trained, authorized staff from SPARK and the study team. All shared data 
will be stored in encrypted folders that will be password-protected and/or require gated access.  
12.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, 
etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
12.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:
We believe that the risks associated with this study are minimal compared to the knowledge that 
will be gained. Informed assent/consent will clearly indicate the limits of confidentiality and that 
confidentiality may need to be broken if there is a safety concern.
We expect that many patients will experience improved sleep and will gain knowledge about their 
sleep. The proposed study also offers clinical assessment for sleep disorders at no cost. 
We believe that the risks associated with this study are minimal compared to the therapeutic 
benefits subjects receive from participating. We believe that by improving sleep of the child with 
ASD we will also positively impact his/her wellbeing and improve behavioral, cognitive, and social 
functioning, as well as reduce caregiver stress. Knowledge gained in this study will have the 
potential to eventually improve the treatment of sleep health deficits during childhood with broad 
potential public health benefits. We believe that the risks associated with this study are minimal 
compared to the knowledge that will be gained.
12.7  
Do you have a Data and Safety Monitoring Plan (DSMP) for this 
DATA AND SAFETY MONITORING: 
* 
study (
): (Click the Help link for guidance 
A DSMP is 
 for Greater than Minimal Risk research
required
 
on risk determination) (REQUIRED)

  Yes  
  No
This is not required for minimal risk research but the UCSF IRB strongly recommends 
one to ensure the data collected are adequate to meet the research aims:
13.0
 Confidentiality, Privacy, and Data Security
13.1  
Indicate how subject privacy will be protected:
PROTECTING PRIVACY: 
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be 
called, can messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added 
to their medical records or shared with others without the subject’s permission
Other methods (describe below)
13.2  
Do any of the instruments ask about illegal or stigmatized behavior:
SENSITIVE DATA: 
  Yes  
  No
13.3  
Could a breach of 
SIGNIFICANT CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
privacy or confidentiality result in any significant consequences to participants, such as criminal or 
civil liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation:
  Yes  
  No
13.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:
To protect participants’ confidentiality, numerical data will be used as unique identifiers and 
identifying information will not be stored with the data. Hard copy data will be maintained in 
locked storage, and electronic data stored on shared computer drives maintained by the 
university under rigorous firewall and password protection. Secured information linking participant’
s ID with protected heath information will be separated from the unidentified data. Consents will 
be kept in docusign. Only the PI and authorized study personnel will have access to the protected 
files. All study records will be stored in REDCAP and be accessible only to the PI and 
authorized members of the research team. No identifying information of any individual subject 
will ever be revealed in any public presentations or publications from the study. Text messages 
(used to deliver the modules to participants) for SweetDreams will use REDCAP, a HIPAA 
compliant server. Audio files of the qualitative exit interviews will be stored in REDCAP. Audio 
recordings will be destroyed upon completion of all data analyses.
13.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others: (REQUIRED)
 Yes  
 No
The confidentiality and privacy section of the consent form should 
include this as a possible risk of participation. 
 
Describe the types of reportable information the research team may 
* 
encounter and provide the details of the reporting plan: (REQUIRED)

Types of reportable information: threat or danger to self/others, child abuse, elder abuse.
Any reports of child or elder abuse, or threat to others will be reported as mandated by the law.
13.6  
Will this study obtain a Certificate of Confidentiality:
CERTIFICATE OF CONFIDENTIALITY: 
 
  Yes  
  No
13.7  
Will there be any sharing of 
 research test results 
SHARING OF RESEARCH RESULTS: 
EXPERIMENTAL
with subjects or their care providers:
  Yes  
  No
13.9  
Study data will be: 
* HIPAA APPLICABILITY: 
(REQUIRED)
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service 
(THREDS) at SFGH
13.10  
Check all identifiers that will be collected and included in the research records, 
IDENTIFIERS: 
* 
even temporarily: (REQUIRED)
Names
Dates
Postal addresses (if only requesting/receiving zip codes check Yes to the Zip Code question 
below instead of checking this box)
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Could study records include 
 photos or images (even 'unidentifiable' 
* 
ANY
ones): (REQUIRED)

  Yes  
  No
13.12  
 
Will health information or other clinical data be accessed from UCSF Health, 
* PATIENT RECORDS: 
Benioff Children's Hospital Oakland, or Zuckerberg San Francisco General (ZSFG): (REQUIRED)
  Yes  
  No
13.19  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)
Collection methods:
Electronic case report form systems (eCRFs), such as OnCore or sponsor-provided clinical trial 
management portal
UCSF ITS approved Web-based online survey tools: Qualtrics or RedCap
Other web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Text Messaging
Wearable devices
Audio/video recordings
Photographs
Paper-based (surveys, logs, diaries, etc.)
Other:
What online survey or computer assisted interview tool will you use: 
* 
(REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
Study sponsor
UCSF data center (including OnCore, RedCap, Qualtrics, and MyResearch)
UCSF encrypted server, workstation, or laptop residing outside of UCSF data center
Personal devices, such as laptops or tablets that are not owned or managed by UCSF
SF VAMC
Zuckerberg San Francisco General Hospital
Benioff Children's Hospital Oakland
Langley Porter Psychiatric Institution
Other UCSF affiliate clinic or location (specify below)
Cloud vendor such as Amazon Web Services (AWS), Salesforce, etc. (specify below)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
13.21  
During the lifecycle of data collection, transmission, and storage, will identifiable 
DATA SHARING: 
* 
 
information be shared with or be accessible to anyone outside of UCSF: (REQUIRED)
  Yes  
  No
14.0
 Financial Considerations

14.1  
Will subjects be paid for participation, reimbursed for time or expenses, or receive any 
* PAYMENT: 
other kind of compensation: (REQUIRED)
 Yes  
 No
14.2  
Subjects payment or compensation method (check all that apply):
PAYMENT METHODS: 
Payments will be (check all that apply):
Cash
Check
Gift card
Debit card
UCSF Research Subject Payment Card
Reimbursement for parking and other expenses
Other:
14.3  
Describe the schedule and amounts of payments, including the total subjects 
PAYMENT SCHEDULE: 
can receive for completing the study:
If there are multiple visits over time, explain how payments will be prorated for partial 
completion
If deviating from recommendations in Subject Payment Guidelines, include specific 
justification below
We have found payment to our subjects to be strong incentive for participating in assessments. 
Thus, we are requesting funds to cover payments to each subject for interviews and assessment 
tasks. ($30 total (for all assessments) x 30 participants per year = $900 per year)
14.4  
Will subjects or their insurance be charged for any study activities:
COSTS TO SUBJECTS: 
  Yes  
  No
15.0
 Other Approvals and Registrations
15.4  
Indicate if this study involves other regulated materials and requires approval 
OTHER APPROVALS: 
and/or authorization from the following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
16.0
 Qualifications of Key Study Personnel and Affiliated 
Personnel
 

NEW: January 2019 - Affiliated personnel who do not 
need access to iRIS no longer need to get a UCSF ID. 
Instead, add them below in the Affiliated Personnel 
table below. 
16.1  
 
Qualifications of Key Study Personnel:
Instructions:
 
For UCSF Key Study Personnel (KSP)* listed in 
 select the KSP 
Section 3.0,
from the drop down list and add a description of their study responsibilities, 
qualifications and training. In study responsibilities, identify every individual 
who will be involved in the consent process. Under qualifications, please 
include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
NOTE: This information is required and your application will be 
 
considered incomplete without it. If this study involves invasive or 
risky procedures, or procedures requiring special training or 
certification, please identify who will be conducting these 
procedures and provide details about their qualifications and 
training. Click the orange question mark for more information and 
examples. 
 
Training Requirements: 
The IRB requires that all Key Study Personnel complete Human Subjects 
Protection Training through 
 prior to approval of a new study, or a 
CITI
modification in which KSP are being added. More information on the CITI 
training requirement can be found on our 
. 
website  
 
* Definition of Key Study Personnel and CITI Training Requirements (Nov, 
 UCSF Key Study Personnel include the Principal Investigator, other investigators 
2015):
and research personnel who are directly involved in conducting research with study 
participants or who are directly involved in using study participants’ identifiable private 
information during the course of the research. Key Personnel also include faculty mentors
/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical 
Fellows serving as PI on the IRB application.
 
KSP Name
Description of Study 
Responsibilities - Briefly 
describe what will each 
person be doing on the study. 
If there are procedures 
requiring special expertise or 
certification, identify who will 
be carrying these out. Also 
identify who will be obtaining 
informed consent.
Qualifications, Licensure, and 
Training
The PI will oversee 
overall management of 
the study.
More specifically the PI 

Dr. Asarnow, Lauren D PhD
will:
-Meet with the CRC 
weekly to ensure that 
recruitment, assessments 
and data collection 
targets are all being met.
-Ensure that all study 
procedures are on target.
-Be available for clinical 
consultation as well as 
clinical emergencies.
-Consult with the DSMB 
as needed to ensure that 
all study procedures are 
on target.
Dr. Asarnow (PhD) is an 
Assistant Professor, 
Department of Psychiatry 
and UCSF Weill Institute 
for Neurosciences. She is 
also a licensed Clinical 
Psychologist.
Dr. Leventhal, Bennett MD
The Primary Mentor will: 
-Work on developing and 
managing the overall 
research plan as well as 
all elements of the 
protocols
-Assist with recruiting, 
enrollment, phenotyping, 
developing research 
strategies, tools and 
operations
-Have a particular role in 
developing and 
monitoring the clinical 
intervention.
Dr. Leventhal (MD) is a 
Professor of Child and 
Adolescent Psychiatry at 
UCSF. He has extensive 
clinical and research 
experience in the area of 
neurodevelopmental 
disorders.
Dr. Bush, Nicole PhD
The Co-Mentor will:
-Support Dr. Asarnow in 
her proposed research, 
both through scientific 
and intervention 
mentorship, as well as 
through providing 
support in recruitment of 
her target population 
through our clinical 
programs.
Dr. Bush (PhD) is an 
Associate Professor of 
Psychiatry and Pediatrics 
and the Division Chief 
(Director) of the Division 
of Developmental 
Medicine in the 
Department of Pediatrics 
at UCSF.
Mirchandaney, Riya
The CRC will will assist 
Dr. Asarnow in executing 
the study.
More specifically the CRC 
will:
-recruit and screen 
participants, manage 
assessments, scheduling, 
data collection, and other 
administrative aspects of 
study operations.
- meet weekly with Dr. 
Asarnow
Riya Mirchandaney has a 
B.A. in Psychology and 
experience as an 
undergraduate RA at 
Columbia University 
working on sleep and 
mental health 
interventions.
16.2  Affiliated Personnel:
Instructions:
 

This section is for personnel who are not listed in Section 3.0: Grant Key 
 because their names were not found in 
Personnel Access to the Study
the User Directory when 
 the iRIS Database and MyAccess directories 
both
were searched. Add any study personnel who fit 
 of the following criteria 
ALL
in the table below:
They meet the definition of Key Study Personnel (see above), and
They are associated with a UCSF-affiliated institution (e.g., VAMC, 
Gladstone, Institute on Aging, Vitalant, NCIRE, SFDPH, or ZSFG), and
They do 
 have a UCSF ID, 
not
and
They do 
 need access to the study application and other study 
not
materials in iRIS.
 in the 
Note: Attach a CITI Certificate for all persons listed below
Other 
 section of the 
Study Documents
Initial Review Submission Packet 
 after completing the 
.
Form
Study Application
 
Click the orange question mark icon to the right for more information on 
who to include and who not to include in this section.
 
Do 
 list personnel from outside sites/non-UCSF-affiliated institutions. 
not
Contacts for those sites (i.e. other institution, community-based site, 
foreign country, or Sovereign Native American nation) should be listed in 
the 
 section of the application.
Outside Sites
 
If there are no personnel on your study that meet the above 
criteria, leave this section blank.
 
Name
Institution
Telephone
E-mail
Role
No External Personnel has been added to this IRB Study
Please describe the study responsibilities and qualifications of each affiliated 
person listed above:
17.0
 End of Study Application
End of Study Application Form
 
:
To continue working on the Study Application
Click on the section you need to edit in the left-hand menu. Remember to save through 
the entire Study Application after making changes.
 
:
If you are done working on the Study Application
Before proceeding, please go back to Section 4.0 Initial Screening 
Important: 
Questions and 
 through the form to make sure all the relevant 
Save and Continue
sections and questions have been included. If you've changed any answers since you 
started, the branching may have changed. Your application will be incomplete and it will 
have to be returned for corrections. 
 
Once you are sure the form is complete, click 
. If this is a new 
Save and Continue
study, you will automatically enter the 
, 
Initial Review Submission Packet Form
where you can attach 
or other 
. Review the 
consent forms 
study documents
Initial 
 for a list of required attachments.
Review Submission Checklist

 
Answer all questions and attach all required documents to speed up your 
approval.
 
 
 
 
 
The UCSF IRB welcomes feedback about the IRB Study Application Form. Please click the link to 
answer a 
 about the application form.
survey

PAGE 1 OF 6
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: Feasibility of a Sleep Intervention for Children with Autism Spectrum 
Disorder (SweetDreams) Study
Research Project 
Director:
Lauren Asarnow, PhD, Assistant Professor, Department of 
Psychiatry and UCSF Weill Institute for Neurosciences.
401 Parnassus Avenue, RM LP-A307, San Francisco, CA 
94143 
Phone: (415) 502-4561; e-mail: Lauren.Asarnow@ucsf.edu
Study Coordinator:
Riya Mirchandaney, Phone: (415) 502-4561; email: 
Riya.Mirchandaney@ucsf.edu
Dr. Asarnow, PhD from the UCSF Department of Psychiatry and UCSF Weill Institute for 
Neurosciences, is conducting a research study to learn more about a web-based health 
intervention and its effectiveness in improving sleep and behavior in children with Autism 
Spectrum Disorder.
STUDY INFORMATION
Research studies include only people who choose to take part. Please take your time to make 
your decision about participating and discuss your decision with your family or friends if you 
wish. If you have any questions, you may ask the researchers.
You were selected as a possible participant in this study because your child is between 12 and 72 
months old, has a diagnosis of Autism Spectrum Disorder and has reported sleep problems. 
Why is this study being done?
The purpose of the Feasibility of a Sleep Intervention for Children with Autism Spectrum 
Disorder (SweetDreams) Study is to learn more about ways to provide effective behavioral 
sleep interventions among children with ASD. Behavioral sleep interventions are a type of 
counseling to help people improve their sleep habits and think in a healthy way about their sleep.
This study is funded by the Clinical & Translational Science Institute (CTSI). The study 
investigators have no conflict of interest regarding financial or proprietary interests. The study 
device is a web-based health program and is not FDA approved.
IRB NUMBER: 20-31365
IRB APPROVAL DATE: 10/02/2021
IRB EXPIRATION DATE: 08/02/2022

PAGE 2 OF 6
How many people will take part in this study?
This research study is looking for about 20 individuals to participate in the study.
What will happen if my child and I take part in this research study?
If you decide to enroll in this study, you and your child’s participation will take place over a 4-
week period. 
If you agree, the following procedures will occur:
1. You will be asked to answer questions during a screening visit to determine if you and 
your child meet the study criteria. You will be asked general questions about your child 
such as age and ethnicity and about your child’s sleep, as well as other questions that will 
allow us to determine if your child meets all study entry criteria. This screening visit will 
take between 40 ~ 60 minutes and will happen over the phone.
2. If your child is determined to be eligible for the study, you and your child will enter the 
baseline part of the study, during which you will be asked more questions about your 
child and about yourself. 
3. At the end of the baseline part of the study, you and your child will be randomized to 
either the SweetDreams intervention condition or the waitlist control condition, which 
will be determined by chance. Like the flip of a coin, you will have an equal chance of 
being assigned to either group. Neither the investigators nor you can request or pre-
specify which condition you will be assigned to.
4. If you and your child are randomized to the SweetDreams intervention, you will then 
receive a behavioral sleep intervention using a program called SweetDreams. We will 
provide you a code that will give you access to the program. 
5. If you and your child are randomized to the waitlist control condition, you will be given 
access to the SweetDreams intervention after a 4-week waitlist period. 
During the study, you and your child will be asked to:
1. Complete Study Assessments that will occur at baseline and at 4 weeks thereafter.  If you 
are in the waitlist condition you will be asked to complete an additional assessment at 8 
weeks. At each assessment you will complete questionnaires.
2. When you and your child are assigned to the SweetDreams intervention group: Engage in 
the SweetDreams intervention. The SweetDreams Intervention is a user friendly 4-week 
web-based intervention, available on mobile phones or other devices. It has two 
components 1) 20-minutes of weekly animated video learning modules, and 2) 5-10 
minutes of digital worksheets to personalize the recommendations from the learning 
modules one or two times per week. Video learning modules will be hosted on a 
password-protected Vimeo™ platform and delivered via REDCap. No data regarding 
usage will be collected, except for timestamps when you open the REDCap link and 
when you mark the form as complete.
IRB NUMBER: 20-31365
IRB APPROVAL DATE: 10/02/2021
IRB EXPIRATION DATE: 08/02/2022

PAGE 3 OF 6
How long will my child and I be in the study?
You and your child’s participation in this study will last about 4 weeks. This period includes 
screening, baseline, 4 weeks of either the intervention or the waitlist control and a final study 
visit that will take place immediately after the 4 weeks. If you are in the waitlist condition you 
will be asked to complete an additional assessment at 8 weeks. The total amount of time 
dedicated to the study (including all study visits and engagement with the intervention) is 
estimated to be 210 minutes (3.5 hours).
Can my child and I stop being in the study?
Yes. You and your child can decide to stop at any time.  Just tell the study researcher or staff 
person right away if you or your child wish to stop being in the study. Also, the study researcher 
may stop you and your child from taking part in this study at any time if they believe it is in your 
or your child’s best interest, if you or your child do not follow the study rules, or if the study is 
stopped.
What side effects or risks can my child and I expect from being in the study?
There are risks, discomforts, and inconveniences associated with any research study.  These 
deserve careful thought.  If you have questions, please ask. You may contact the study team if 
you have any questions about the intervention. The risks associated with this study are minimal. 
•
Some of the questions in the interviews and questionnaires are of a personal nature and could 
possibly be emotionally upsetting (e.g. questions about caregiving stressors, family conflict, 
etc.).  
•
Some children experience increased daytime sleepiness in the early stages of one of the sleep 
therapies being provided in this study. Typically, if sleepiness emerges as a side effect of the 
intervention, it disappears as the intervention progresses.  You should alert your study 
coordinator should your child experience an increase in sleepiness. 
•
Some individuals may find it stressful to try new behavioral strategies with their children. 
Relatedly, some children may find it stressful to develop new routines and may act out in 
response to new limits. 
•
Randomization risks: You will be assigned to a treatment program by chance, and the 
treatment you receive may prove to be less effective or to have more side effects than the 
other study treatment(s) or other available treatments. If the intervention (SweetDreams) 
were to be effective and your child is placed in the non-treatment (wait-list control) group, 
this would mean that your child's treatment will be delayed by 4 weeks (one month).
•
The study intervention or procedures may involve risks that are currently unforeseeable. 
•
It is possible that, based on information gained from this study, the researchers may be 
required to report information (e.g., information relating to suicide, physical or sexual abuse) 
to the appropriate authorities.
•
Although every reasonable effort has been taken, confidentiality during Internet 
communication procedures cannot be guaranteed and it is possible that additional 
information beyond that collected for research purposes may be captured and used by others 
not associated with this study.
•
For more information about potential risks, ask one of the researchers.
IRB NUMBER: 20-31365
IRB APPROVAL DATE: 10/02/2021
IRB EXPIRATION DATE: 08/02/2022

PAGE 4 OF 6
Are there benefits to taking part in the study?
You may benefit from participating in the study (i.e. there may be improvements in your child’s 
sleep and associated daytime impairment), but this cannot be guaranteed. Your child’s 
participation may provide the investigators valuable data, which may lead to advances in the 
intervention of individuals with sleep problems and increased access to this type of mental health 
care.  
You and your child’s participation and time, therefore, may ultimately lead to broader benefits 
for society and for people who experience problems sleeping. We cannot and do not guarantee or 
promise that your child will receive any benefits from this study. You and your child’s decision 
whether or not to participate in this study will not affect you or your child’s medical care.
What other choices do I have if I do not take part in this study?
The web-based intervention that you and your child will be receiving as part of their 
participation in the study is a standard intervention for sleep concerns. Another standard 
intervention for sleep problems that is not provided in this study is taking a sleep medication or 
in-person therapy. Your child’s participation does not preclude their engagement in any 
intervention for sleep problems outside the study (but please tell us about it). In addition, you and 
your child may choose not to participate in this research study.
You and your child are free to choose not to participate in the study.  If you and your child 
decide not to take part in this study, there will be no penalty to you or your child. You and your 
child will not lose any of your regular benefits, and you and your child can still get your care 
from our institution the way you usually do.
Will information about my child be kept private?
Participation in research involves some loss of privacy. If information from this study is 
published or presented at scientific meetings, your name and other personal information will not 
be used. We will do our best to make sure that the personal information gathered for this study is 
kept private. However, we cannot guarantee total privacy. Your personal information may be 
given out if required by law.
If information is revealed about child abuse or neglect, elder or dependent abuse or neglect, or 
potentially dangerous future behavior to others or yourself, the law requires that this information 
be reported to the proper authorities.
Authorized representatives from the following organizations may review your research data for 
the purpose of monitoring or managing the conduct of this study: 
•
Representatives of the University of California
•
Representatives of the Food and Drug Administration (FDA)
Although participation in research may involve a loss of privacy, information about you and your 
child will be handled as confidentially as possible. 
For those individuals who participated in the SPARK study, we are asking your consent for the 
SPARK study, hosted by the Simons Foundation, to share with the University of California, San 
Francisco the clinical, demographic and genetic data collected during your participation in 
SPARK. This information will be shared using your linked research ID number and using a 
secure transfer system.
IRB NUMBER: 20-31365
IRB APPROVAL DATE: 10/02/2021
IRB EXPIRATION DATE: 08/02/2022

PAGE 5 OF 6
We are also asking for your consent to share the data we collect during the study here at the 
University of California, San Francisco with SPARK in order to add to the information that was 
collected during your participation in SPARK. Please note that because you are a participant in 
both studies, SPARK and this study will be able to share and link your identifying information as 
well as any future data you may contribute to either project. To safeguard your confidentiality, 
all data-sharing will occur via a secure transfer system, and access to identifiable data will be 
limited to trained, authorized staff from SPARK and the study team. All shared data will be 
stored in encrypted folders that will be password-protected and/or require gated access.  
The Simons Foundation funds innovative research and provides coded data access (data with 
your identifying information removed) to qualified researchers. Researchers can file an 
application with the Simons Foundation to obtain access to your study data for research 
purposes. Experts at the Simons Foundation who protect health and science information will look 
at every request carefully to minimize risks to your privacy.
Are there any costs to me for taking part in this study? 
No, there is no cost for you or your child for taking part in the study.
Will I be paid for taking part in this study?
In return for your time, you and your child will be paid a gift card worth a total of $30, regardless 
of which group you are assigned to.
What happens if my child and/or I am injured because I took part in this study?
It is important that you tell your study doctor, Dr. Asarnow, if you feel that you or your child 
have been injured because of taking part in this study. You can tell the doctor in person or call 
them at 415-502-4561.
Treatment and Compensation for Injury:  If you or your child are injured as a direct result of 
being in this study, the University of California will provide necessary medical treatment. The 
costs of the treatment may be billed to you or your insurer just like any other medical costs, or 
covered by the University of California, depending on a number of factors. The University and 
the study sponsor do not normally provide any other form of compensation for injury. For further 
information about this, you may call the office of the Institutional Review Board at 415- 476-
1814. 
What are my rights if I take part in this study?
Taking part in this study is your choice.  You may choose either to take part or not to take part in 
the study.  If you decide to take part in this study, you may leave the study at any time.  No 
matter what decision you make, there will be no penalty to you in any way. You will not lose any 
of your regular benefits, and you can still get your care from our institution the way you usually 
do. You and your child are also free to participate in other research studies.
Who can answer my questions about the study?
You can talk to the researchers about any questions, concerns, or complaints you have about this 
study.  Contact Dr. Asarnow at Lauren.Asarnow@ucsf.edu or 415-502-4561.
If you wish to ask questions about the study or your rights as a research participant to someone 
other than the researchers or if you wish to voice any problems or concerns you may have about 
the study, please call the Institutional Review Board at 415-476-1814.
IRB NUMBER: 20-31365
IRB APPROVAL DATE: 10/02/2021
IRB EXPIRATION DATE: 08/02/2022

PAGE 6 OF 6
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time.
CONSENT
You have been given a copy of this consent form to keep.
PARTICIPATION IN RESEARCH IS VOLUNTARY.  You have the right to decline to be in 
this study, or to withdraw your child from it at any point without penalty or loss of benefits to 
which you or your child are otherwise entitled.
The participant being considered for this study is unable to consent for themselves because they 
are a minor. By signing below, you are giving your permission for your child to be included in 
this study.
Date
Parent or Legal Guardian
Date
Person Obtaining Consent
 
IRB NUMBER: 20-31365
IRB APPROVAL DATE: 10/02/2021
IRB EXPIRATION DATE: 08/02/2022