Families FORWARD: Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum
Phase: NA
Conditions: Autism Spectrum Disorder, Family Relations
Sponsor: Boston University Charles River Campus

 
 
 
   
 
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Version:  August 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The following includes the full study protocol for project 
“Transitioning Together: Development of a Family-Based Transition Planning Program 
for Culturally-Diverse Youth on the Autism Spectrum” (NCT05965648) 
Protocol most recently approved by the Boston University Charles River IRB on 
August 21, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
   
 
2 
Version:  April 2022 
BU Charles River IRB 
Application Form (Full Board and Expedited Review) 
 
SECTION A:  PROTOCOL AND CONTACT INFORMATION 
Protocol Title:   
Development of a new family-focused transition program 
Principal Investigator 
(Name, degrees, licenses, etc.): 
☐ Mr.   ☒ Ms. 
Kristin Long, PhD   
             Department/School: Dept. of Psychological and Brain Sciences / CAS 
BU Mailing Address: 
900 Commonwealth Ave., 2nd Floor 
             Email: 
kalong@bu.edu 
             Telephone: 
617-358-4296 
Additional Contact Person: 
Marcella Mazzenga 
              Email: 
mmazz@bu.edu 
              Telephone: 
617-358-1633 
☒ YES 
(REQUIRED) 
I confirm that I qualify to serve as the Principal Investigator of this study and 
am in compliance with the following policies: 
http://www.bu.edu/researchsupport/compliance/human-subjects/  
 
SECTION B:  FUNDING 
Provide information regarding ALL funding sources for this project, including existing funding, 
pending funding, and funding that has been applied for to support this research.  
Please check all that apply: 
☒ 
This research is funded 
 
☐ 
Funding has been requested  
Have you received Just In Time (JIT) Notification?   ☒ Yes    ☐ No 
NOTE: Once the funding has been awarded, submit an amendment to the IRB to 
add the funding source 
☐ 
Research is not funded 
 
If the research is funded or funding has been requested, it is REQUIRED that you complete 
the box below.  If you don’t have an award #, please state that in the box below.  If you have 
multiple funding sources, add additional boxes as necessary. 
Sponsor Name 
Deborah Munroe Noonan Memorial Research Fund 
Title of 
Grant/Proposal 
Development of a Family-Based Transition Planning Program for 
Culturally-Diverse Youth on the Autism Spectrum 
Sponsor Award # 
(REQUIRED)* 
*If Award is pending, 
put “pending”.   
(No award number given) 
YES 
NO 
 

 
 
 
   
 
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☒ 
☐ 
Is Boston University the Prime Awardee of the grant? 
☐ 
☒ 
Is Boston University receiving a sub-award? 
Name of Prime Recipient: 
☐ 
☒ 
Is the research being supported by an Industry Contract or Clinical Trial 
Agreement?  
*NOTES:   
• Provide a copy of the grant application, funding proposal, contract/agreement, scope of work, 
or sub-award agreement supporting the research. If an award is pending, once the funding has 
been awarded, submit an amendment to the IRB to add the funding source. 
• If this research study is for your dissertation, provide a copy of your prospectus (if available). 
 
SECTION C:  CONFLCT OF INTEREST 
☒ YES 
(REQUIRED) 
I confirm that ALL those responsible for the design, conduct, or reporting 
of the proposed research, including at minimum, all Senior/key personnel in 
the grant application, have completed the financial interest disclosure forms, 
submitted them to the COI office, and completed training as dictated at: 
http://www.bu.edu/researchsupport/compliance/conflicts-of-interest/,  and 
as provided under the Boston University Investigator Conflicts of Interest 
Policy for Research.     
 
NOTE:  You must attach a copy of the PI’s COI submission confirmation 
email. COI submission confirmation emails for all other study staff 
should be maintained at the research site.     
Of the financial interest disclosure forms submitted, did you check “yes” to any of the questions 
on either the FIND1 or NONFIND1 form?               ☐ Yes*     ☒ No 
*If you checked “yes” to any of the questions on either the FIND1 or NONFIND1 form, the 
IRB Director will contact the COI office to obtain the disclosure information. 
 
SECTION D:  TYPE OF REVIEW 
For Guidance regarding Type of Review please refer to the CRC IRB website  
 
I. 
FULL BOARD ☐ 
Please refer to the CRC IRB website for Full Board submission deadlines and meeting dates. 
 
II. 
EXPEDITED ☒ 
In order to qualify for expedited review, the study must be no more than minimal risk* AND 
must fall into one of the categories below.  Check all that apply: 
 
1. ☐  Clinical studies of drugs and medical devices only when condition (a) or (b) is met. 
(a) Research on drugs for which an investigational new drug application (21 CFR Part 
312) is not required. (Note: Research on marketed drugs that significantly increases 

 
 
 
   
 
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the risks or decreases the acceptability of the risks associated with the use of the 
product is not eligible for expedited review.) 
(b) Research on medical devices for which (i) an investigational device exemption 
application (21 CFR Part 812) is not required; or (ii) the medical device is 
cleared/approved for marketing and the medical device is being used in accordance 
with its cleared/approved labeling. 
 
2. ☐ Collection of blood samples by finger stick, heel-stick, ear stick, or venipuncture as 
follows: 
a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, 
the amounts drawn may not exceed 550 ml in an 8-week period and collection may 
not occur more frequently than 2 times per week; or 
b. From other adults and children, considering the age, weight, and health of the 
subjects, the collection procedure, the amount of blood to be collected, and the 
frequency with which it will be collected. For these subjects, the amount drawn may 
not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may 
not occur more frequently than 2 times per week. 
 
3. ☐ Prospective collection of biological specimens for research purposes by 
noninvasive means. Examples include hair and nail clippings, saliva or cheek swabs, 
sweat, etc. 
 
4. ☐ Collection of data through noninvasive procedures (not involving general 
anesthesia or sedation) routinely employed in clinical practice, excluding procedures 
involving x-rays or microwaves. Where medical devices are employed, they must be 
cleared/approved for marketing. Examples:  
• Physical sensors that are applied either to the surface of the body or at a distance 
and do not involve input of significant amounts of energy into the subject or an 
invasion of the subject’s privacy  
• Weighing or testing sensory acuity  
• Magnetic resonance imaging  
• Electrocardiography, 
electroencephalography, 
thermography, 
detection 
of 
naturally occurring radioactivity, electroretinography, ultrasound, diagnostic 
infrared imaging, doppler blood flow, and echocardiography  
• Moderate exercise, muscular strength testing, body composition assessment, and 
flexibility testing where appropriate given the age, weight, and health of the 
individual 
 
5. ☐ Research involving materials (data, documents, records, or specimens) that have 
been collected, or will be collected solely for non-research purposes (such as medical 
treatment or diagnosis)  
 
6. ☒ Collection of data from voice, video, digital, or image recordings made for research 
purposes. 
 

 
 
 
   
 
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7. ☒ Research on individual or group characteristics or behavior (including, but not 
limited to, research on perception, cognition, motivation, identity, language, 
communication, cultural beliefs or practices, and social behavior) or research 
employing survey, interview, oral history, focus group, program evaluation, human 
factors evaluation, or quality assurance methodologies.  
  
Note:  The IRB will make the final determination on the Type of Review 
*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or tests. 
 
SECTION E:  STUDY STAFF AND HUMAN SUBJECTS TRAINING 
List ALL current members of the research team in the table below.  Add more rows as necessary. 
 
STUDENT RESEARCH: 
The Faculty Advisor must be listed as a co-investigator in this section and must complete the 
Human Subjects training requirements. Faculty Advisors are responsible for reviewing the IRB 
application, agreeing to serve as the Co-PI for this study with the student and are responsible for 
the ethical conduct of this student’s human subjects research. Faculty Advisors must sign this 
Application prior to it being submitted to the IRB. 
 
BU CHARLES RIVER CAMPUS (CRC) INVESTIGATORS/STUDY STAFF 
Note: Boston University Medical Campus (BUMC) investigators/study staff should be listed in 
the NON-BU INVESTIGATOR/STUDY STAFF section 
 
Name, Degree, & 
Department/School 
Study Role (e.g. co-investigator, 
research coordinator, research 
assistant, project manager, lab 
manager) 
Human Subjects Training* 
Kristin Long, PhD, 
Dept. Psychological 
and Brain Sciences/ 
College of Arts & 
Sciences 
PI 
☒ CITI 
☐ Other**:__________ 
Most Recent Date Completed: 
7/04/2020 
Gael Orsmond, PhD, 
Dept. Occupational 
Therapy/Sargent 
College  
Co-I 
☒CITI 
☐Other**: 
Most Recent Date Completed: 
9/13/2020 
Christina Amaro, 
PhD, CAS 
Department of 
Psychological and 
Brain Sciences 
Post-doctoral Researcher 
☒ CITI 
☐ Other**: 
Most Recent Date Completed: 
09/03/2020 

 
 
 
   
 
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Monica Gordillo, 
MA, CAS 
Department of 
Psychological and 
Brain Sciences 
Graduate Student Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
5/24/2019 
Jenna Eilenberg, 
MA, MPH, CAS 
Department of 
Psychological and 
Brain Sciences 
Graduate Student Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
7/18/2020 
Ariel Blakey, MA, 
CAS Department of 
Psychological and 
Brain Sciences 
Graduate Student Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
09/04/2019 
Kathryn Davis, MA, 
CAS Department of 
Psychological and 
Brain Sciences 
Graduate Student Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
9/04/2019 
John ‘Jay’ Wilson, 
MA, CAS 
Department of 
Psychological and 
Brain Sciences 
Graduate Student Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
9/13/2020 
Emily Wunder, BA, 
CAS Department of 
Psychological and 
Braine Sciences 
Graduate Student Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 12/8/21 
Marcella Mazzenga, 
BA, CAS 
Department of 
Psychological and 
Brain Sciences 
Assistant Research Technician (Staff) 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 6/6/2020 
Caroline Hollahan, 
BA, CAS 
Department of 
Psychological and 
Brain Sciences 
Research Assistant (Staff)  
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 2/7/2019 
Huanrui ‘Ben’ Wei, 
CAS Department of 
Psychological and 
Brain Sciences 
Undergraduate Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
10/20/2021 
Shumin Guan, CAS 
Department of 
Psychological and 
Brain Sciences 
Undergraduate Research (Staff) 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
10/25/2021 

 
 
 
   
 
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Pamela Ruiz, CAS 
Department of 
Psychological and 
Brain Sciences 
Undergraduate Researcher (Staff) 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
10/16/2021 
Freya Zhu, CAS 
Department of 
Psychological and 
Brain Sciences 
Undergraduate Researcher 
☒  CITI 
☐  Other**: 
Most Recent Date Completed: 
11/17/2021 
Oksana Litardo, 
Sargent College 
 
Graduate Student Researcher  
☒ CITI 
☐ Other**: 
Most Recent Date Completed:  
9/2/2019 
 
Yeook Kim 
Sargent College 
 
PhD student 
☒ CITI 
☐ Other**: 
Most Recent Date Completed:  
9/3/2021 
 
Sharada Krishnan 
Sargent College 
 
PhD student 
☒ CITI 
☐ Other**: 
Most Recent Date Completed:  
9/3/2021 
 
Anuoluwa Ayannusi, 
Sargent College 
Undergraduate Researcher 
☒ CITI 
☐ Other**: 
Most Recent Date Completed: 
10/9/2021 
 
Carissa Mastrangelo, 
CAS Department of 
Psychological and 
Brain Sciences 
Undergraduate Researcher 
☒ CITI 
☐ Other**: 
Most Recent Date Completed: 
1/11/2022 
 
 
Julia Duda 
Undergraduate Researcher 
☒ CITI 
☐ Other**: 
Most Recent Date Completed: 6/6/2021 
 
Rachel Meyer 
Undergraduate Researcher 
☒ CITI 
☐ Other**: 
Most Recent Date Completed: 6/2/2021 
 

 
 
 
   
 
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TBA 
Program Facilitator (Based at the Arc) 
☐ CITI 
☐ Other**: 
Most Recent Date Completed:  
 
 
• *For more information regarding the Human Subjects Training Policy, refer to the ‘Training’ 
section of the Policies & Guidance section IRB website.  
• **If the investigator/study staff did not complete CITI, you must submit a copy of his/her 
training certificate. 
 
NON-BU INVESTIGATORS/STUDY STAFF*  
 
 
☐ N/A 
Note: BUMC and BMC staff are considered non-BU staff and should be listed in this section. Add 
more rows as necessary. All the columns in the box below must be completed.  In addition, you 
must complete the box that follows with a description of the activities for each staff member.   
Name, Degree, 
Institution 
Study Role 
Staff Information 
Will IRB Approval 
be Obtained from 
Non-BU Institution? 
Amanda Brandone, 
PhD 
Lehigh University 
1. Will this staff 
interact with subjects? 
☒ Yes          ☐ No 
 
2.Will this staff have 
access to identifiable 
information? 
☒ Yes          ☐ No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
☐ Yes          ☒ No 
 
☐ Yes:  Provide copy 
of IRB approval letter 
when available: 
☒ No (provide 
reason): Lehigh has 
ceded review to BU 
IRB 
Wenyan Feng, MA 
Lehigh University 
1. Will this staff 
interact with subjects? 
☒ Yes          ☐ No 
 
2. Will this staff have 
access to identifiable 
information? 
☒ Yes          ☐ No 
 
☐ Yes; provide copy 
of IRB approval letter 
 
☒ No (provide 
reason):  Lehigh has 
ceded review to BU 
IRB 

 
 
 
   
 
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3. Is the work that the 
staff will complete 
related to their role or 
coursework at their 
institution? 
☐ Yes          ☒ No 
*If IRB approval will be obtained from the affiliate site, only list the lead investigator from the 
affiliate on this form. 
 
The box below must be completed.  Include a summary for each staff listed in the above box.  
If any of the investigators listed on this form are not affiliated with BU, provide a summary of the 
study activities that he/she will conduct.  If IRB approval is not being obtained at the affiliate 
institution, provide an explanation.  NOTE:  Non-BU staff may be required to complete an 
Individual Investigator Agreement (IIA).  The IRB will notify you if this form is required. 
Dr. Amanda Brandone and Ms. Wenyan Feng at Lehigh University will contribute to 
recruitment, consenting, data collection, and data analysis for Phase 1 of the study. This will 
include – but may not be limited to – working with families who speak Mandarin or Cantonese 
as their primary language. 
 
REQUIRED GOOD CLINICAL PRACTICE TRAINING FOR NIH-FUNDED 
CLINICAL TRIALS 
YES* 
NO 
NIH-FUNDED CLINICAL TRIALS 
☐ 
☒ 
Is your study NIH-Funded AND meet the definition of a clinical trial as defined 
in the NIH policy?    
 
SECTION F:  LOCATION OF THE RESEARCH 
YES* 
NO 
 
☒ 
☐ 
Will this research take place at sites/locations other than Boston University? 
Note:  If the research will take place at Boston University, state the location 
(Building and Room number): 
*If YES, please complete the boxes below 
 
NOTE:  You are responsible for obtaining permission/letters of support for research conducted 
off-site. This may include locations such as schools, workplaces, community organizations, etc.  
You must submit the letters/documentation of support with this application. 
Institution Name and 
Address (if known) 
Describe Involvement 
(recruiting, consenting, data 
analysis, etc.) of the site.  If the 
site or the site staff is not 
involved (engaged)1 in research 
procedures, state NONE. 
IRB/Ethics Approval/Site 
Permission Attached?  If 
no2, explain the plan to 
obtain this approval.  If the 
site is not engaged in the 
research, you do not need 
to complete the box. 
Northeast Arc 
6 Southside Rd. 
Danvers, MA 01923 
Site will serve as recruitment 
source as well as intervention 
site. Staff at the Arc site will 
No - Site is not engaged in 
research. 

 
 
 
   
 
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conduct the telehealth program 
with participants. BU research 
staff will supervise, consent, and 
conduct all data collection. 
Brockton Area Arc 
1250 West Chestnut St. 
Brockton, MA 02301 
 
Site will serve as recruitment 
source as well as intervention 
site. Staff at the Arc site will 
conduct the telehealth program 
with participants. BU research 
staff will supervise, consent, and 
conduct all data collection. 
No - Site is not engaged in 
research. 
Communitas (Arc) 
60-D Audubon Rd, 
Wakefield, MA 01880 
Site will serve as recruitment 
source as well as intervention 
site. Staff at the Arc site will 
conduct the telehealth program 
with participants. BU research 
staff will supervise, consent, and 
conduct all data collection. 
No - Site is not engaged in 
research. 
Lehigh University 
Collaborators at Lehigh 
University will contribute to 
recruiting, consenting, data 
collection, and analysis. 
No - Submitted a single IRB 
request (BU = reviewing 
IRB; Lehigh = relying IRB) 
1Guidance on Engagement of Institutions in Human Subjects Research  
2If IRB approval will not be obtained at the site, describe the IRB oversight arrangements here:  
 
 
YES* 
NO 
 
☒ 
☐ 
Is the off-site location requesting that the Boston University IRB review the 
protocol in place of local IRB review? If YES, complete the Single IRB Review 
Form “Boston University is Institution A”  
 
YES* 
NO 
 
☒ 
☐ 
Is the BU PI the lead investigator OR is BU the lead site for this research? 
Note:  This box only needs to be completed if the off-site location is engaged 
in the research. 
*If YES, provide the following information in this box:  
• The plan for collection and management of data from all the sites 
• The plan for reporting and evaluating: 
• Unanticipated problems 
• Serious and/or continuing non-compliance 
• Suspensions and terminations of research 
• Interim results 
• Protocol modifications 
• The name of the Principal Investigator from each site  

 
 
 
   
 
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• If IRB approval will be obtained at the site, confirmation that you have a copy (or will 
obtain a copy) of the IRB approval letters and the IRB-approved protocols from each site  
• 
If IRB approval will be obtained at the site, confirmation that the site IRB has a 
FederalWide assurance (FWA)  
 
The Lehigh team will be involved in consenting and data collection for Phase 1 of the study. The 
site PI at Lehigh is Dr. Amanda Brandone; Dr. Brandone will oversee the work done by her 
graduate student, Ms. Wenyan Feng. We will use a secure SharePoint site for the secure 
exchange of research information (consent forms, interview recordings and transcripts), as this 
site can be accessed from research personnel across both universities. The Sharepoint site will be 
created and maintained by research staff at BU. The Lehigh team also will be involved with 
coding qualitative data.  
Dr. Long (PI) will have regular contact with the Lehigh team. If any unanticipated problems 
occur, Dr. Long will take responsibility for reporting this to the IRB at BU. If any serious and/or 
continuing instances of non-compliance occur, Dr. Long will reevaluate the collaboration, and if 
necessary, move all research activities to BU. 
IRB approval will not be obtained at Lehigh, as they will cede review to BU’s IRB. (Lehigh 
does have a FWA). 
 
YES* 
NO 
 
☐ 
☒ 
Will this research be conducted outside of the United States?  
If YES, complete the International Research Form.  
 
SECTION G:  STUDY SUMMARY 
Summarize the study in lay language (do not copy from the grant/scope of work/proposal, 
etc.). This summary should include the research design, purpose, objectives, research 
question, hypothesis, and any relevant background information.   
 
Do not include a list of citations in this section.  Please limit this section to no more than 300 
words. 
For youth on the autism spectrum, the transition to adulthood has been described as “falling off a 
cliff” due to the lack of available adult services and families feeling overwhelmed and 
unsupported. Although the transition to adulthood is universally challenging for families, it is 
also a time of increasing race/ethnicity-based service use disparities. No existing family-based 
programs focus on skills to navigate transition, are broad enough to include families of youth 
with a wide range of autism presentations, and consider cultural influences on transition 
processes or post-transition goals. We plan to develop a family-based transition planning 
program that addresses these gaps.  
We will develop a program to increase family members’ involvement in autism-related transition 
planning, with a focus on ensuring cultural relevance. The Families FORWARD (Focusing on 
Relationships, Well-being, and Responsibility aheaD) program will be delivered collaboratively 
with community organizations that support individuals on the autism spectrum. Parents/primary 
caregivers will participate in individual, personalized telehealth modules that incorporate aspects 
of motivational interviewing, skill-building (problem-solving; communication), and 
psychoeducation about services. Transition-aged youth on the autism spectrum will be 

 
 
 
   
 
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incorporated into the program to maximize their input in collaborative planning. A community 
advisory board (CAB) of key stakeholders will actively shape all stages of the research. CAB 
members will not have access to data or identifiable information. 
The project aims to: 
(1) develop the 6- to 7-session Families FORWARD program with culturally-diverse families 
and service providers. Parents/primary caregivers, youth on the autism spectrum (ages 14-21), 
and community providers will participate in individual interviews. Feedback will be used to 
refine the program’s goals, format, and content.  
(2) conduct proof-of-concept testing with a stratified sample of families who identify as Black, 
Latinx of any race, Asian, and non-Latinx White. Twenty families will participate in Families 
FORWARD and will provide feedback on the program and the research procedures. 
 
SECTION H: RESEARCH METHODS AND ACTIVITIES  
(Check all that apply) 
☒ 
Collection of audio, video, digital, or image recordings 
☐ 
Biological samples ® Complete Biological Samples Form 
Examples:  blood, hair, cheek swab, urine, tears, saliva, etc. 
☐ 
Collection of data that may be sensitive and if disclosed could put subjects at risk for 
legal or social harms. (e.g. Illegal behaviors, HIV status, psychiatric illness, information 
related to sexual behaviors, etc. 
☐ 
Coordinating Center/Lead Site 
☐ 
Deception 
☐ 
Devices ® Complete Devices Form 
☐ 
Drugs ® Complete Drugs Form 
☒ 
Ethnographic: The study of people in their own environment through the use of 
methods such as participant observation and face-to-face interviewing 
☐ 
Focus Groups 
☐ 
Genetics Testing ® Complete Genetics Form  
☐ 
MRI 
☐ 
Placebo 
☐ 
Pregnancy Testing 

 
 
 
   
 
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☐ 
Randomization 
☒ 
Surveys, interviews, questionnaires 
☐ 
Secondary Data Analysis 
☐ 
Other (please describe):  
 
SECTION I:  PARTICIPANT POPULATION 
Provide the Number of Participants to be Enrolled. If you have sub-groups or more than 
one arm, please separate out these enrollment numbers. Note: Please account for 
participants who may drop out or be withdrawn from the study. Anyone who signs a consent 
form is considered to be enrolled in the research regardless of whether they complete any study 
procedures. 
 
Individual interviews:  
1. 15 service providers  
2. 35 parents / caregivers  
3. 25 transition-aged youth on the autism spectrum (ages 14-21) 
 
Proof of concept trial:  
1. 20 families, including parents/caregivers and (when possible) transition-aged youth 
2. 4 program facilitators 
 
Notes:  
- 
Families can participate in EITHER Phase 1 (interviews) OR Phase 2 (proof-of-
concept trial), but not both. 
- 
Parent participants: In both phases of the study, we anticipate enrolling one parent per 
family. However, a second parent / primary caregiver will be eligible to enroll, if 
warranted. The enrollment numbers above account for the possibility of >1 parent per 
family. 
- 
Autistic youth / young adult participants: For Phase 1, multiple individuals from the 
same family may enroll if they meet inclusion criteria. The enrollment numbers above 
account for the possibility of >1 autistic individual enrolled per family. For Phase 2, 
only one autistic individual may enroll. 
 
 
Check all categories that apply to your participant population: 
☒ 
Adults 
 
☒ 
Children (< 18 years of age) 

 
 
 
   
 
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☒ 
Adults with Limited Decision-Making Capacity 
☒ 
Non-English Speaking 
☐ 
Prisoners 
☐ 
BU Employees 
☐ 
BU Students 
☐ 
Wards of the state 
☐ 
Other (please describe): 
 
If a population other than ‘Adults’ has been checked, describe the additional safeguards 
that have or will be put in place to protect those individuals, and provide the rationale for 
including this population in the research study. For information on additional protections, 
please see the ‘Supplemental Guidance’ section of the CRC IRB webpage.  
Program development phase (Phase 1): Transition-aged youth on the autism spectrum (ages 
14-21) will be asked to participate in individual data collection appointments in which we will 
ascertain the acceptability of the proposed program and collect data on these individuals’ 
preferences regarding program goals and formats. In order to participate, the individuals on 
the autism spectrum must be able to share their perspective in either verbal or written format 
and be able to provide consent or assent (if they are not their own legal guardian) for 
participation. Data collection will be conducted in English, Spanish, Cantonese, and 
Mandarin. 
 
Proof-of-concept testing phase (Phase 2): Transition-aged youth on the autism spectrum (ages 
14-21) may participate in 2 telehealth sessions and provide written feedback about the 
program (via post-session feedback forms) if it is appropriate. The participating 
parents/caregivers will inform the researchers of whether they think their child is able and 
willing to participate both in the session and/or in completing the feedback form. If necessary, 
these feedback forms can be completed with the support of a research team member, family 
member, service provider, or other support person. Youth who participate in the program 
sessions will be considered research participants, regardless of whether or not they complete 
the session feedback forms. We will attempt to collect session feedback forms from all autistic 
youth participants and will track data collection completion as a measure of feasibility. Data 
will be collected in English. 
 
For both phases of this research, we have chosen to include cognitively-impaired individuals 
to increase participation of youth across the autism spectrum, including those with 
accompanying intellectual disability. This decision is consistent with person-centered 
approaches in autism and disability-related service provision whereby the affected individual 

 
 
 
   
 
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is included in all discussions and decisions about his/her/their care. This inclusive approach is 
expected to improve the program that is being developed. 
 
In Phase 1, we will enroll linguistically-diverse individuals. Our research group has 
experience conducting multi-lingual studies, and the PI will closely oversee the work of 
bilingual research team members who will interact with families in Spanish, Cantonese, 
Mandarin, and English. 
 
 
Eligibility Criteria 
Members of the research team will conduct a phone screen to ensure eligibility.  
 
Inclusion Criteria:  
 
Phase 1 
1. Parents or primary caregivers of transition-aged youth on the autism spectrum:  
a. Have one or more child(ren) on the autism spectrum who is/are ages 14-21 years old  
b. Identify as the parent, legal guardian, and/or primary caregiver of the youth  
c. Speak English, Spanish, Cantonese, or Mandarin fluently 
2. Youth on the autism spectrum:  
a. Have an autism diagnosis OR identify as autistic 
b. Age 14-21 
c. Have ability to communicate verbally or in written format 
d. Speak English, Spanish, Cantonese, or Mandarin fluently 
3. Service providers:  
a. Have professional experiences in serving individuals on the autism spectrum and/or 
their families. 
b. Age 18+ 
c. Speak English, Spanish, Cantonese, or Mandarin fluently 
 
Phase 2 
1. Parents or primary caregivers of transition-aged youth on the autism spectrum:  
a. Have one or more child(ren) on the autism spectrum who is/are ages 14-21 years old  
b. Identify as the parent, legal guardian, and/or primary caregiver of the youth  
c. Speak English fluently 
d. Reside in Massachusetts  
2. Youth on the autism spectrum:  
a. Have an autism diagnosis OR identify as autistic 
b. Age 14-21 
c. Have ability to communicate verbally or in written format 
d. Speak English fluently 
e. Reside in Massachusetts* 
3. Service providers:  
a. Have professional experiences in serving individuals on the autism spectrum and/or 
their families. 
b. Age 18+ 

 
 
 
   
 
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c. Speak English fluently 
 
*Note: Lehigh University staff will NOT be conducting Phase 2 of the study. 
 
Exclusion Criteria (exclusion criteria are the specific criteria which would disqualify an 
individual from participating in the study not simply the opposite of the inclusion criteria):  
 
Phases 1 & 2 
1. Parents/caregivers: none 
2. Youth on the autism spectrum: Youth will be excluded if their abilities would preclude 
them from sharing their perspective either in written or verbal format (e.g., due to 
significant cognitive or language challenges) 
3. Service providers: none 
 
 
SECTION J:  RECRUITMENT 
Provide a summary of the recruitment process, including who will recruit, when and 
where recruitment will occur, and how subjects will be identified 
 
Submit all recruitment materials (e.g. advertisements, brochures, flyers, letters/e-mails, 
scripts, etc.) as separate documents in either Word or PDF format. 
Parents and youth (Phases 1 and 2) will be recruited through community partners including 
but not limited to local Arc chapters, the Arc of Massachusetts, the Massachusetts Sibling 
Support Network (MSSN), Autism/Asperger Network (AANE), and Boston Medical Center. 
These community partners may distribute a recruitment flier via in-office postings, postal 
mail, and email, or they may include information about the study on their social media pages. 
Participants also may be recruited via our Community Advisory Board or word of mouth. 
Finally, families may be recruited by re-contacting families that either (a) participated in our 
previous autism-focused studies and provided permission to learn about future studies or (b) 
who expressed interest in previous studies but were not eligible and asked to learn of future 
research opportunities.  
 
When recruiting parents and youth for Phase 1, participant characteristics will be reviewed 
periodically to ensure breadth in the sample based on family race and ethnicity as well as 
youth age. Continued recruitment will target families with characteristics not as well 
represented in the sample. 
 
When recruiting families for Phase 2, we will enroll a stratified sample to ensure that families 
of different races and ethnicities are included, as follows: Black (n = 4-5), Asian (n = 4-5), 
Latinx of any race (n = 4-5), non-Latinx white (n = 4-5). We will ask about family 
race/ethnicity during the telephone screen. 
 
Community providers. For Phase 1, community providers will be identified through local 
and state-wide Arc chapters; recruitment fliers will be posted in the local offices and 
distributed via email. Additionally, we will use IRB-approved recruitment materials to recruit 
through social media (e.g., Facebook page). For Phase 2, we will hire 2-4 community-based 

 
 
 
   
 
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providers to serve as program facilitators. These providers also will serve as research 
participants when providing feedback on the program via session feedback forms and exit 
interviews.  
 
For both families and community providers, individuals who are interested in participating, 
but prefer that the research team makes initial contact with them, can do so by entering their 
contact information into a consent-to-contact portion of our lab’s website (see “Consent-to-
Contact Write-Up” document), after which a member of the research team will contact them to 
provide more details about the study. Alternately, if professionals or community partners 
obtain verbal consent for a potential adult participant (e.g., parent/caregiver or service 
provider) to be contacted by the researcher, the professional or community partner will 
communicate this information to the research team, and a member of the research team will 
reach out directly to the potential participant. 
 
Note about roles: The majority of recruitment activities will be carried out by members of the 
BU research team. However, Lehigh staff also may contribute to disseminating recruitment 
materials for Phase 1. This may include sharing fliers with community groups in PA or 
elsewhere.  
Only research-trained staff of Boston University and Lehigh University will be involved in the 
consent process and the collection of research data; community advisory board members and 
Arc-based program facilitators may help disseminate fliers about the study, but they will NOT 
be involved in any research procedures (consent, data collection, etc.). Lehigh University will 
be involved in Phase 1 of the study, but not Phase 2.  
 
Please Note: Phase 2 recruitment materials (flier, letter, etc.) will be developed after Phase 1 
is complete and will be submitted to the IRB for approval at a later date. This will ensure that 
the Phase 2 recruitment materials accurately reflect the final format and content of the 
program being developed. 
Spanish and Chinese versions of Phase 1 recruitment materials will be submitted to the IRB 
upon approval of the English versions. 
 
SECTION K:  CONSENT AND ASSENT 
Please refer to the consent and assent form templates on the IRB website when creating your 
consent/assent documents. The templates include the required elements of consent and will help 
to ensure that your consent/assent form meets the requirements of the federal regulations and the 
BU CRC IRB.   
 
STUDENT RESEARCHERS must: 1) indicate in the consent form/information sheet/script that 
he/she is a student and 2) list the Faculty Advisor as a contact in the form/sheet/script. 
 
Provide a summary of the consent process, including who will consent participants, when 
and where consent will occur. The summary should include, as appropriate, any waiting 
period between informing the prospective participant about the research and obtaining 
consent, such that the prospective participant or the legally authorized representative has 
sufficient opportunity to consider whether to participate, and steps taken to minimize 
coercion or undue influence. 

 
 
 
   
 
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Submit copies of all consent forms and scripts; materials should be submitted as separate 
documents in Word format. 
Adult individuals (parents/primary caregivers, service providers, or young adults on the autism 
spectrum who are their own guardians) who are interested in hearing more about the study will 
contact the researchers to express their interest, complete a consent-to-contact form on our 
study website, or provide verbal consent to professionals or community partners that the 
research team can reach out to them to provide information about the study.  
 
All informed consent procedures will be carried out by members of the research team who are 
based at BU or Lehigh University; the Arc partners and Community Advisory Board members 
will not be involved in obtaining informed consent.  
 
Phase 1 interviews:  
Verbal consent will be obtained from parents/primary caregivers, service providers, and 18- to 
21-year-old individuals on the autism spectrum who are their own legal guardian. If the 
individual on the autism spectrum has a legal guardian (ages 18-21) or is under 18 years old, 
verbal consent will be obtained from the guardian. The research team will learn of 
guardianship status of the individual on the autism spectrum during the phone screen. A 
research team member will describe the goals of the study, answer questions, and obtain 
verbal consent or assent from the participants. Potential participants will have the option of 
thinking about whether they want to participate. Participants will be provided with a copy of 
the consent or assent document, and the original will be kept in the confidential research file.  
 
For individuals who are not their own legal guardians, there may be situations in which the 
legal authorized representative provides consent for the individual on the autism spectrum to 
participate in the study, but the individual on the autism spectrum does not wish to participate. 
If this occurs, we will first reach out to the individual on the autism spectrum to address any 
specific concerns about the study. If they still do not wish to participate, the individual on the 
autism spectrum will not be enrolled, and the legal authorized representative will be informed 
that the individual on the autism will not be enrolled. 
 
Note: for individuals on the autism spectrum who may prefer or require written 
communication, there will be an option for them to ask questions and confirm their 
assent/consent using a written format (e.g., in email exchanges or via a “chat” function on 
zoom or other platforms).  
 
Phase 2 proof-of-concept testing:  
Parents/primary caregivers will provide consent for participation in the proof-of-concept 
testing before they complete pre- program measures or participate in program sessions. 
Measures will be administered through a web-based survey (Qualtrics), which will include the 
consent form. We will not require written consent from the parents / primary caregivers; 
rather, they will indicate their consent through continuing to the questionnaires after reading 
the consent document and answering the questions posed within the consent form. Thus, we 
are requesting a waiver of documentation of written consent. Because each participant is 
accessing Qualtrics via a unique personal link, the answers to the questions on the consent 

 
 
 
   
 
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form will be linked to each participant’s data on the surveys. In a separate document on the 
secure site, trained research staff will have access to the key to match up personal Qualtrics 
links and identifiable participant information (including names). Parents / primary caregivers 
may also complete the consent and surveys over the phone or zoom, in which a member of the 
research team reads the questions aloud and records the participant’s responses using the 
participant’s personal link in Qualtrics.  
 
We also will request, but not require, individuals on the autism spectrum to provide consent 
or assent for their family’s participation in the proof-of-concept trial. There are many 
situations that may preclude obtaining consent/assent from the individual on the autism 
spectrum or legal guardian; therefore, we will reach out to these individuals to request their 
consent/assent, but if we are not able to obtain it, we will still enroll the parent / primary 
caregiver (but the individual on the autism spectrum will only be enrolled if they provide 
consent/assent). Individuals on the autism spectrum who participate in any program sessions 
and/or provide session feedback will be asked to provide consent or assent in order to 
participate. 
 
We will determine whether the individual on the autism spectrum can provide consent or 
whether he/she/they have a guardian by asking parents and/or service providers during the 
study screening procedures. Because youth on the autism spectrum will not be completing 
measures via Qualtrics, we will request verbal consent/assent for their participation in the 
study. If verbal/nonverbal behaviors indicate the individual on the autism spectrum is unable 
to provide consent/assent, we will verbally share study information, and ask for verbal assent, 
with a yes/no response documented by research staff. If no verbal response is provided, we 
will document this as well, and carefully monitor the individual on the autism spectrum’s 
willingness to participate, and we will continue unless nonverbal behaviors show 
unwillingness to participate. If the individual on the autism spectrum shows signs of being 
unwilling to participate, we will move forward with research activities with only the parent / 
primary caregiver. 
 
For individuals who are not their own legal guardians, there may be situations in which the 
legal authorized representative provides consent for the individual on the autism spectrum to 
participate in the study, but the individual on the autism spectrum does not wish to participate. 
If this occurs, we will first reach out to the individual on the autism spectrum to address any 
specific concerns about the study. If they still do not wish to participate, the individual on the 
autism spectrum will not be enrolled, and the legal authorized representative will be informed 
that the individual on the autism will not be enrolled. In these cases, the parent/primary 
caregiver can still be enrolled in the proof-of-concept trial.  
 
Note: for individuals on the autism spectrum who may prefer or require written 
communication, there will be an option for them to ask questions and confirm their 
assent/consent using a written format (e.g., in email exchanges or via a “chat” function on 
zoom or other platforms).  
 
Finally, we will request verbal consent from service providers who will be providing 
feedback on the program. 

 
 
 
   
 
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General note: When families (individuals on the autism spectrum and their parents / primary 
caregivers) are recruited into either Phase 1 or Phase 2 of this research study, they will be 
informed that their decision on whether or not to enroll will not impact the eligibility or 
quality of services for the individual on the autism spectrum. When service providers are 
recruited into the interview portion of the study, they will be informed that their decision on 
whether or not to enroll is completely voluntary and will not impact any aspect of their 
employment. 
 
 
Indicate the consent and/or assent process and document(s) to be used in this study.   
Check all that apply 
Consent:  Adults (>18 years old); One of the following MUST apply                        N/A ☐ 
☒ 
Consent Form/Information Sheet 
 
☒ 
Verbal Consent (Script) 
Note:  If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation Consent’ box (Box 1) located further down in this section 
☐ 
Consent will not be obtained 
Note:  If consent will not be obtained, complete the ‘Waiver or Alteration of Consent’ 
box (Box 2) located further down in this section 
 
Assent of Children (< 18 years old); One of the following MUST apply                   N/A ☐ 
☒ 
Assent Form OR Parent Consent Form/Information Sheet (older children may sign the 
parent consent form along with their parents as long as the consent form is written at 
the grade level of the subjects) 
 
This will be used for parents/caregivers enrolled in Phase 2 of the project (proof-
of-concept testing) 
 
☒ 
Verbal Assent (Script) 
 
This will be used for (1) parents/caregivers, youth, and service providers enrolled 
in Phase 1 of the project and (2)  youth and service providers enrolled in Phase 2 
of the project 
 
☐ 
Assent will not be obtained; one of the following conditions must exist:    
 
1. ☐ The capability of some or all of the children is so limited that they cannot 
reasonably be consulted;  
 
2. ☐ The children are too young to provide assent; 
 

 
 
 
   
 
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3. ☐ The intervention or procedure involved in the research holds out the prospect of 
direct benefit to the health or well-being of the children and is available only in the 
context of the research   
 
4. ☐ The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 45 
CFR 46.116(d)*.  (Complete the ‘Waiver or Alteration of Consent’ box (Box 2) 
located further down in this section) 
 
Guidance on age requirements for obtaining assent: 
• Parental Permission for minors under 6 years old 
• Verbal assent for minors 6-11 years old 
• Written assent from minors ages 12-17 (unless verbal consent is approved for the 
parents/adult subjects 
Parental Permission; One of the following MUST apply                                           N/A ☐ 
☐ 
Parental Consent Form 
 
 
 
☒ 
Parental Verbal Consent (Script) 
 
Note: If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation of Consent’ box (Box 1) located further down in this section 
☐ 
Parental permission will not be obtained; one of the following conditions must exist: 
 
1. ☐ The research protocol is designed to study conditions in children or a subject 
population for which parental or guardian permission is not a reasonable requirement 
to protect the subjects (for example, neglected or abused children). 
 
2. ☐ The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 45 
CFR 46.116(d)*.  (Complete the ‘Waiver or Alteration of Consent’ box (Box 2) 
located further down in this section). 
 
Consent:  Adults with Limited Decisional Capacity to Consent (>18 years old)   N/A ☐ 
 
Describe the consent and/or assent process for enrolling adults with limited decisional 
capacity to consent to research. Including how decisional capacity will determined, and who 
will serve as Legally Authorized Representative. 
For the proof-of-concept trial, we will request – but not require – consent from individuals on 
the autism spectrum or their legal guardian. The research team will learn of guardianship status 
of the individuals on the autism spectrum by asking parents and/or service providers during the 
study screening procedures. We will attempt to obtain assent from the individual on the autism 
spectrum if possible. If verbal/nonverbal behaviors indicate the individual on the autism 
spectrum is unable to provide assent, we will verbally share study information, and ask for 
verbal assent, with a yes/no response documented by research staff.  

 
 
 
   
 
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There may be situations in which the legal authorized representative provides consent for the 
individual on the autism spectrum to participate in the study, but the individual on the autism 
spectrum does not wish to participate. If this occurs, we will first reach out to the individual on 
the autism spectrum to address any specific concerns about the study. If they still do not wish to 
participate, the individual on the autism spectrum will not be enrolled, and the legal authorized 
representative will be informed that the individual on the autism will not be enrolled. 
 
 
Assent will be obtained from: 
☐ All Subjects 
☒ Some Subjects, specify: Individuals on the autism spectrum who show signs of being unable 
to provide consent will be asked to provide verbal assent. Other individuals on the autism 
spectrum who are their own guardians will be asked to provide consent. 
☐ No Subjects 
 
☒ 
Consent will be obtained from the subject’s Legally Authorized Representative (LAR) 
(REQUIRED).  
Who will serve as LAR: The individual’s legal guardian will serve as the LAR. 
 
CONSENT OF NON-ENGLISH SPEAKING SUBJECTS                            N/A ☐                   
Describe the process for obtaining consent from non-English speaking subjects.  List the 
individual who will serve as the interpreter and his/her qualifications. 
 
NOTE: A copy of the translated consent along with the Attestation Form for Translation of 
Consent must be submitted.  The Attestation Form can be located on the IRB website. 
 
The procedures for obtaining consent for Spanish-, Cantonese-, and Mandarin-speaking 
participants will be the same as those for consenting English-speaking participants. For example, 
two graduate student researchers from BU, Monica Gordillo and Oksana Litardo, are bicultural, 
bilingual Spanish speakers and have been extensively trained in research methodology. 
Similarly, a research staff member from Lehigh University (Wenyan Feng) is a bicultural, 
bilingual Mandarin- and Cantonese-speaker who has been trained in this research methodology. 
They all have experience conducting research with individuals with autism and their families 
and will be closely supervised by the PI. 
 
 
BOX 1—WAIVER OF WRITTEN DOCUMENTATION OF CONSENT 
 
WAIVER OF WRITTEN DOCUMENTATION OF CONSENT   N/A ☐      
Either Criteria 1 or 2 must be met in order to qualify                  
Yes 
No 
☐ Criteria 1 
The research is NOT FDA Regulated 
☐ 
☐ 
The only record linking the subject and the research would be the consent 
document 
☐ 
☐ 

 
 
 
   
 
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The principal risk would be potential harm resulting from a breach of 
confidentiality 
☐ 
☐ 
Each subject will be asked whether the subject wants documentation linking 
the subject to the research and the subject’s wishes will govern 
☐ 
☐ 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information:  
 
☐ 
☐ 
 ☒ Criteria 2 
The research is NOT FDA Regulated 
☒ 
☐ 
The research presents no more than minimal risk of harm to subjects 
☒ 
☐ 
The research involves no procedures for which written consent is normally 
required outside of the research context 
☒ 
☐ 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information: 
 
☒ 
☐ 
☐ Criteria 3 
The research is NOT FDA Regulated 
☐ 
☐ 
The research presents no more than minimal risk of harm to subjects 
☐ 
☐ 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
☐ 
☐ 
There is an appropriate mechanism for documenting that informed consent was 
obtained 
☐ 
☐ 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information: 
 
☐ 
☐ 
 
 
 
BOX 2—WAIVER OR ALTERATION OF CONSENT 
 
NON-FDA REGULATED STUDIES 
WAIVER OR ALTERATION OF CONSENT                    N/A ☒                   
45 CFR 46.116 Waiver or alteration of consent. The IRB may approve a 
consent procedure which does not include, or which alters, some or all of 
the elements of informed consent set forth in this section, or waive the 
requirements to obtain informed consent provided the IRB finds and 
documents ALL of the criteria listed below: 
Yes 
No 
 
 
The research involves no more than minimal risk to the subjects; 
☐ 
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; 
☐ 
☐ 
The research could not practicably be carried out without the waiver or 
alteration; 
☐ 
☐ 

 
 
 
   
 
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If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using 
such information or biospecimens in an identifiable format; 
☐ 
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation.  If NO, provide rationale for not providing this 
information: 
 
☐ 
☐ 
Provide the justification/rationale for why this study meets the above criteria for waiving 
or altering consent (REQUIRED): 
 
 
 
FDA-REGULATED STUDIES 
Per FDA guidance issued in July 2017, the IRB may waive or alter informed 
consent requirements for certain minimal risk clinical investigations when 
the IRB finds and documents ALL of the criteria listed below: 
Yes 
No 
 
 
The clinical investigation involves no more than minimal risk (as defined in 21 
CFR 50.3(k) or 56.102(i)) to the subjects; 
☐ 
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; 
☐ 
☐ 
The clinical investigation could not practicably be carried out without the 
waiver or alteration 
☐ 
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation.  If NO, provide rationale for not providing this 
information: 
 
☐ 
☐ 
Additional Comments: 
 
 
 
 
SECTION L:  STUDY PROCEDURES 
In the box below provide a detailed description of the study procedures to be performed 
(preferably in sequential order). Be sure to specify which procedures are for research 
purposes and which procedures are part of standard of care, if applicable. Be sure to 
include the following information: 
• Methods of data collection  
• Details regarding research activities/procedures/interventions 
• Number, frequency, duration and types of subject contacts (visits, phone calls, internet 
surveys, mailings, etc.) 
• Time required from each subject 
• Use of equipment (eye-tracker, treadmill, sensors, etc.). Provide a brief description of 
equipment that will be used in the study.* 
  

 
 
 
   
 
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*Note: The IRB may request more information about the equipment (including equipment 
manuals) and/or request that you submit Appendix C: Device Form. 
 
Submit copies of all surveys, interview questions, assessments, screening scripts, etc. that 
will be used during the conduct of this study; materials should be submitted as separate 
documents in either Word or PDF format. 
 
Methods of Data Collection 
Phase 1: Individual Interviews.  
The first phase of data collection involves qualitative interviews (carried out in either verbal or 
written format) with transition-aged youth on the autism spectrum, parents/primary caregivers, 
and service providers. Qualitative data will be collected in English, Spanish, Mandarin, and 
Cantonese. The interviews will aim to understand current experiences of transition to adulthood 
and associated planning, including: (1) family involvement in transition planning, (2) services 
and supports related to transition planning, and (3) cultural considerations related to autism, 
transition, and adulthood. Interviews also will probe families’ and providers’ perceptions of 
Families FORWARD, including: (1) their enthusiasm for a program to engage parents in 
transition planning, (2) preferences for program components, format, and timing, (3) ideas on 
how to maximize flexibility so that the program has the broadest possible reach and benefit, and 
(4) ideas on how to incorporate the preferences of the individual on the autism spectrum. 
Participants will be presented with an overview of the program and will be asked to provide 
feedback on the content, format, and materials. Finally, they will be asked to provide high-level 
feedback on other potential interventions for families of transition-aged youth, such as a parental 
problem-solving intervention.  
 
Participants will be provided with a variety of options to complete qualitative interviews. 
Parents/guardian and service providers will be asked to participate in traditional verbal 
interviews. They may choose to interview in-person at a setting of their choice or remotely via 
telephone or teleconferencing (e.g., Zoom). As long as covid-related precautions remain in 
place, there will be preference for remote forms of data collection. We will continue to recruit 
participants until saturation is reached in the primary research questions (i.e., when more 
interviews do not generate additional information). Some individuals on the autism spectrum 
may be more comfortable providing data in written format (e.g., in a series of email exchanges 
or in a real-time written chat with a researcher); this alternate mode of interviewing will be 
offered to individuals on the autism spectrum who are interested in being interviewed but who 
are unable to or uncomfortable with completing the verbal interview. 
 
In addition to the qualitative interview, parents/caregivers will complete a background 
questionnaire to provide information about their demographics and educational activities (see 
Phase 1 & 2 Family Background Form). We expect that the research visit, including the consent 
process, qualitative interview, and survey measure, will last approximately 1.5 - 2 hours. 
Participants will be compensated $50 for completion of the study interview and background 
form. 
 

 
 
 
   
 
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Participant characteristics will be reviewed periodically to ensure breadth in the sample based on 
race, ethnicity, and youth age. Continued recruitment will target families with characteristics not 
as well represented in the sample. 
 
Interviews will be audio recorded using BU-approved version of Zoom and/or handheld audio 
recorders, transcribed verbatim, and checked for accuracy. Interviews will be transcribed in one 
of two ways: 1) using a password protected account on Amazon Transcribe or 2) by 
undergraduate or graduate student researchers with training in research ethics. Only approved 
study staff will have access to the Amazon Transcribe account. Audio recordings will be 
temporarily uploaded to the account for transcription (a process that takes approximately an 
hour) and then deleted from the account immediately following transcription. All transcripts 
(whether transcribed by an approved study staff member or Amazon Transcribe) will be 
reviewed a second time by a study staff member to check for accuracy and ensure that all 
potentially identifying information has been removed. All transcripts will be labeled with unique 
participant ID numbers. Audio recordings will be moved to a limited-access lab folder after 
transcription is complete in case it is necessary to reference the original recording to clarify 
information during analysis. If a participant does not consent to be audio recorded, the interview 
will be conducted without audio recording and the interviewer’s notes will be coded. De-
identified transcripts will be entered into a qualitative software program, NVivo12, to facilitate 
coding and analysis.   
 
Phase 1 data will be collected by BU- and Lehigh-based researchers. 
 
Finally, Phase 1 participants who (1) speak English or Spanish and (2) provide consent to be re-
contacted for future research opportunities may be contacted about participation in another 
study. The research team from Protocol #5790E may reach out to ascertain these participants’ 
interest in completing two standardized measures of the skills and abilities of the 
adolescent/young adult on the autism spectrum. During the consent process for Protocol #5790E, 
participants will be informed that their questionnaire data will be linked with the qualitative 
interviews completed as part of this study. For those families who consent to participate in 
questionnaires as part of Protocol #5790E, their qualitative data from this study will be shared 
with the Protocol #5790E research team. 
 
Phase 2: Proof-of-Concept Testing.  
Once the program is finalized, 20 families will participate in proof-of-concept testing to assess 
program acceptability and feasibility. This step is crucial due to the plan to utilize community 
providers to deliver the program in a telehealth format. Given the small scope of the current 
project, participating families will need to be fluent in English (not necessarily as a first 
language) to participate in the trial. The sample will be stratified by race/ethnicity, including 
approximately equal numbers of families who identify as Black, Latinx of any race, Asian, and 
non-Latinx white. Parent race/ethnicity will be ascertained during the telephone eligibility 
screener. 
 
Each service provider will receive in-depth training on the principles and components of the 
program prior to implementation and will participate in weekly meetings to monitor progress, 
troubleshoot concerns, and receive intensive consultation on the program. Parents will 

 
 
 
   
 
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participate in the six- to seven-session program and will complete questionnaires pre- and post-
participation. Sessions are designed to be delivered once every 2 weeks, though there will be 
flexibility with scheduling if families need to hold sessions outside of this window. After each 
session, program facilitators and family participant(s) will complete a brief open-ended session 
feedback form, and service providers will upload session recordings to the secure BU site. 
Family participants (parents/caregivers and youth on the autism spectrum) and service providers 
will participate in exit interviews to collect overall perceptions of the program, assess program 
satisfaction, and identify areas for improvement. Individuals on the autism spectrum may 
provide their feedback in either verbal or written format. Phase 2 measures are expected to take 
approximately 20 minutes at Time 1 (parents/caregivers) and Time 2 (parents/caregivers, youth 
on the autism spectrum, and providers). Participating parents also will be asked to participate in 
six or seven 60-minute program sessions.  
 
Phase 2 data will be collected by BU-based researchers. However, facilitators are also listed as 
staff because they will be engaged in delivering a research-based program. Please note that 
facilitators will be considered both staff and participants in this project, and they will be 
compensated for their time learning and delivering the program. 
 
Families FORWARD Program Description 
This is a preliminary description, which will be updated once Phase 1 data collection is 
complete. 
The Families FORWARD program will engage families in planning for adulthood. Empirically-
informed treatment targets include parent self-efficacy and higher expectations for adult 
outcomes, which will be bolstered by skill-building in communication and problem-solving; 
guided practice in setting realistic goals, breaking down goals into incremental action steps, and 
problem-solving barriers to goal attainment; repeated engagement in future-oriented discussions; 
and instruction on navigating transition and adult services. To improve implementation, the 
program will be delivered via community organizations (i.e., local Arc chapters) that support 
transition-age youth on the autism spectrum. Parents/caregivers will participate in six or seven 
telehealth sessions (60-75 minutes) and will create individualized transition goals. The 
individual on the autism spectrum will be invited to participate in one session, but they are not 
required to do so. The program is designed to enable flexible delivery for families of youth who 
are diverse across autism severity, co-occurring conditions, service needs, values, and readiness 
to engage in planning.  
Families FORWARD Sessions (P = Parent, Y = Youth on the Autism Spectrum) 
Pre-Session 
(Optional): 
Autism Info. 
(P) 
- 
Education about autism characteristics, common needs, and service systems 
- 
Autism as a life course condition 
- 
Relevance of supporting individuals on the autism spectrum into adulthood 
Session 1: 
Introduction, 
Assessment, 
- 
Rapport-building 
- 
Psychoeducation about autism during the transition to adulthood 
- 
Rationale and introduction to Families FORWARD 

 
 
 
   
 
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Telehealth Technology. During the proof-of-concept trial, the Families FORWARD program 
will be delivered via synchronous videoteleconferencing (VTC) technology. VTC technology 
enables the secure delivery of interactive meetings that incorporate audio and video streams of 
data across multiple sites. Based on a review of existing VTC providers and the requirements of 
& Motivation 
(P) 
- 
Assessment of transition planning to date (within or outside of schools) and 
relevant goals, family roles, and cultural values 
- 
Overview of domains of transition planning (housing, education, guardianship, 
etc.) 
- 
Identification of a high-level transition planning program goal 
- 
Motivational enhancement to actively engage in transition planning 
Session 2: 
Communic-
ation & 
Goal-Setting 
(P) 
- 
Guidance regarding breaking down larger goals into action steps 
- 
Rationale for strong communication with family members, community-based 
providers, school personnel, & other community members 
- 
Principles of effective communication, including conveying cultural values 
- 
Discussion of youth’s communication style 
- 
Practice of effective communication via role-playing transition planning scenarios 
with youth, community-based providers, and/or school personnel 
- 
Specific communication goal-setting for between-session practice 
Session 3: 
Family 
Collaboration  
(P & Y) 
- 
Introduction of Families FORWARD to youth on the autism spectrum 
- 
Identification of youth’s post-transition goals or preferences  
- 
Discussion of alignment between youth’s and parent’s goals 
- 
Clarification or redefinition of parent and youth roles moving forward 
- 
Revision of program goal to incorporate youth’s preferences 
Alternate version of Session 3 for families of youth who are not willing/able to 
participate directly (parent only): 
- 
Articulation of youth’s communication style and parent’s experience 
communicating with youth 
- 
Assessment of parent’s awareness of youth’s post-transition goals and preferences 
- 
Development of strategies to encourage greater consideration of youth’s 
preferences 
- 
Revision of program goal to incorporate youth’s preferences 
Session 4: 
Systems 
Navigation & 
Participation 
(P) 
- 
Overview of autism-related systems and services for transition-aged youth and 
adults (community, residential, medical, mental health, occupational, educational) 
- 
Identification of service system(s) that are most relevant for the family’s individual 
transition goals 
- 
Development of strategies for learning about and/or navigating through these 
systems 
- 
Identification of specific next steps for systems navigation and participation 
Session 5:  
Problem-
Solving (P) 
- 
Guidance regarding effective problem-solving skills 
- 
Normalization of barriers to working toward transition planning goals within or 
outside schools 
- 
Anticipation of potential barriers specific to the family’s planning goals (e.g., 
autism stigma, discrimination, language barriers, immigration considerations) 
- 
Practice of problem-solving strategies to address these specific barriers 
- 
Revision of program goal to incorporate learning to date 
Session 6: 
Moving 
Forward (P) 
- 
Review of skills and progress made during the program 
- 
Creation of a specific action plan for continued work toward planning goals after 
the program ends that includes long-term goals, proximal goals, and concrete next 
steps 
- 
Proactive identification and problem-solving of any remaining barriers 

 
 
 
   
 
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the proposed research, we plan to use Zoom software, a high quality and user-friendly 
videoconferencing format. Zoom has a HIPAA-compliant version that was developed for use in 
healthcare settings; this version of Zoom features complete end-to-end 256-bit AES encryption 
and compliance with HIPAA regulations. The host sends participants a secure link through 
which to access the meeting/session, and can require a password (provided by the host) to join 
the meeting; thus, families do not need to register for their own Zoom account. Zoom software 
clearly identifies the user to the host, after which the host must manually admit the participant to 
the meeting room. The HIPAA-compliant version of Zoom does not store or retain any session 
content on a network, which allows providers to comply with HIPAA regulatory guidelines 
relating to use, disclosure, and storage of confidential information. The HIPAA-compliant 
version of Zoom allows for local recording by the host (but not by participants), which will 
allow the research team to review sessions to assess fidelity. 
 
Measures 
Phase 1 (Qualitative Interviews) Measures 
1. Demographics Questionnaire. A background form will include questions that assess 
family composition & income; family members’ age, gender, race/ethnicity, native 
language, immigration, education, & employment; youth’s school type & presence of co-
occurring medical, mental health, or developmental conditions; & current autism 
services. Time to complete: <5 minutes. 
 
 
Phase 2 (Proof-of-Concept Testing) Measures 
 
Measures at Time 1 – PARENTS (~20 minutes total): 
2. Demographics Questionnaire. A background form will include questions that assess 
family composition & income; family members’ age, gender, race/ethnicity, native 
language, immigration, education, & employment; youth’s school type & presence of co-
occurring medical, mental health, or developmental conditions; & current autism 
services. Time to complete: <5 minutes. 
3. Autism Symptom Severity. Parents will rate their child’s autism symptoms using the 
Current form of the Social Communication Questionnaire (SCQ; Rutter, Bailey, & Lord, 
2003). The SCQ is a 40-item proxy-report measure used to assess the presence of 
specific autistic behaviors. The items represent three areas of functioning: reciprocal 
social interaction, language and communication, and repetitive and stereotypical 
behaviors, where higher scores indicate more severe behaviors. The SCQ has established 
psychometric properties in children and adults and has good reliability and convergent 
validity Chandler et al., 2007). The SCQ manual provides additional information on 
factor analyses, item validity, and ROC analyses that support its validity. Psychometric 
properties are good, with alpha reliabilities ranging from .84 to .93 in older age groups. 
Time to complete: <10 minutes 
4. Functional Independence. Parents will rate their child’s functional independence using 
the Waisman Activities of Daily Living Scale (W-ADL; Smith et al., 2012). The 17 
items cover the domains of personal care, housekeeping, and mealtime activities. Each 
item is rated on a 3-point scale (0=does not perform the task at all; 1=performs the task 

 
 
 
   
 
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with help; 2=performs the task independently). Items will be summed for a total score. 
Good reliability (alpha > .90) has been reported. Time to complete: <5 minutes. 
5. Family Communication about Future Planning. Parents will rate the frequency with 
which they have had family discussions about planning for the future of their child on 
autism spectrum. Parents will respond to a 1-item measure previously used in a study 
evaluating a peer-support program for aging caregivers of adults with intellectual and 
developmental disabilities (Heller & Caldwell, 2006). The item is scored on a 3-point 
scale (not discussed at all, discussed somewhat, discussed a great deal). Time to 
complete: <1 minute. 
 
Measures at Time 2 – PARENTS/YOUTH/PROVIDERS (~20 minutes total): 
6. Exit Interview (20 minutes). Parents, providers, and individuals on the autism spectrum 
who participate in the program will be invited to share their feedback about their overall 
satisfaction with the program and will be asked to reflect on aspects of the program that 
were most and least helpful. They will be asked to discuss the extent to which the 
program met the needs of participants and to identify ways in which the program can be 
improved. Time to complete: 20 minutes.  
7. Family Communication (see above) – parents only. Time to complete: <1 minute. 
 
All questionnaire data will be collected by the Boston University study team via Qualtrics (or in 
person/over the phone if necessary) in order to separate data collection from the Arc providers. 
We will track this data collection method to inform future data collection logistics.  
 
Please Note: Much of the content for Phase 2 will be determined using Phase 1 data. Therefore, 
we will submit an amendment with additional recruitment materials and measures prior to 
starting Phase 2. 
Spanish and Chinese versions of Phase 1 research materials will be submitted to the IRB upon 
approval of the English versions. 
 
SECTION M:  RISKS 
Describe any expected risks to subjects. Consider physical, psychological, social, political, 
legal, economic, or other risks that are related to the study.   
The risks in this study are considered minimal. The specific assessment instruments and general 
qualitative interview methodology have been routinely employed in minimal-risk research 
studies. Participants may experience some emotional discomfort in discussing or completing 
questionnaires about their family life or psychosocial functioning. We will attempt to minimize 
any distress by assuring participants that they can refuse to answer any questions they do not feel 
comfortable answering. All research staff and Arc service providers will be trained and 
supervised to help participants manage any discomfort they encounter during the project. There 
is also a possibility that participants will disclose mental health risks or safety concerns to the 
research staff during the course of research participation. If this occurs, Dr. Long (PI and 
licensed clinical psychologist) will be on-call in the event of a clinical emergency during data 
collection appointments. Direct referral to providers for evaluation will be provided with 
participants’ written authorization. There is also a small risk of breach of confidentiality.  
 
 

 
 
 
   
 
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Describe the plan to minimize risks. Include in the description the availability of any 
medical or psychological resources.  
We will attempt to minimize any distress associated with discussing sensitive topics by assuring 
participants that they can refuse to answer any questions they do not feel comfortable answering.   
 
There is a possibility that participants will disclose mental health risks to the research team 
during the course of data collection. Dr. Long (PI) is a licensed clinical psychologist experienced 
in the management of mental health risks. She will be on-call at all times and available for 
research team members or service providers to call to obtain guidance if imminent risk is 
uncovered during any research-related activities. We will provide families with appropriate 
community resources, as necessary. If the participant provides explicit written consent, an 
appropriate mental health referral will be made. There are some exceptions to confidentiality 
protection: if in the course of conducting research-related procedures information is revealed 
that requires mandatory reporting of child or elder abuse or imminent harm by self or others, 
such information may be provided to the appropriate authorities without participants’ written 
consent. Dr. Long will serve as the contact person for any mental health concerns that arise 
during research procedures carried out by either the BU team (Phases 1 and 2) or the Lehigh 
team (Phase 1 only). 
 
Some aspects of the proposed study will use a virtual / telehealth format, so alternative 
safeguards have been taken to ensure protection of confidentiality throughout these portions of 
the study, such as use of the HIPAA-compliant version of Zoom software. Zoom has a HIPAA-
compliant version that was developed for use in healthcare settings; this version of Zoom 
features complete end-to-end 256-bit AES encryption and compliance with HIPAA regulations. 
The host sends participants a secure link through which to access the meeting/session, and can 
require a password (provided by the host) to join the meeting; thus, families do not need to 
register for their own Zoom account. Zoom software clearly identifies the user to the host. The 
HIPAA-compliant version of Zoom does not store or retain any session content on a network. 
The HIPAA-compliant version of Zoom allows for local recording by the host, which will allow 
the research team to review sessions to assess fidelity. Phase 1 interviews will be conducted and 
recorded using either HIPAA-Zoom or Zoom pro, both of which have been vetted by BU’s IT 
department and are considered to have acceptable levels of security for research involvement. 
Phase 2 program sessions will be conducted and recording using HIPAA-Zoom, given the 
community-based design. 
 
Video and audio recordings collected by BU or Lehigh investigators and/or Arc-based program 
facilitators will be transferred to a password-protected secure network drive at BU and secure 
cloud storage (when interviews are conducted remotely by BU or Lehigh investigators or Arc 
providers), and will be deleted from the local laptops. The secure Sharepoint site is maintained 
by the BU-based research team. 
 
During Zoom sessions, first names only will be used and all family members will be asked to 
announce themselves at the beginning of the interview to verify that there is no else in the room. 
All Zoom sessions will be recorded to the BU encrypted, password-protected network drive or a 
secure SharePoint site for adherence purposes and will be labeled with the unique particpant ID 
number; only researchers specific to the study will be given access to the folder where these 

 
 
 
   
 
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videos are stored, and this access must be provided on an individual case by case basis by the 
Desktop Services Specialist in BU IT for the Psychology Department. Data collected by both the 
BU- and Lehigh-based study staff – as well as session recordings being recorded by the Arc-
based program facilitators – will be uploaded to a Sharepoint site that is being created and 
maintained by the BU-based research team. 
 
 
SECTION N:  BENEFITS 
Describe the potential benefits to subjects related to the study.  State if there are no direct 
benefits. NOTE: Compensation and/or course credit are not considered benefits. 
There are no known direct benefits to participating in this research. Families participating in this 
research may benefit from individualized support in planning for the transition to adulthood and 
adult services, which may improve the extent and helpfulness of services obtained into 
adulthood. Families and service providers may perceive a benefit by knowing that the 
information provided will assist in the eventual development of better services for culturally-
diverse transition-aged youth with autism, for whom there has historically been few evidence-
based services. 
 
 
Describe the potential benefits to society and/or others related to the study 
 
In the next decade, over one half million youths with ASD will enter adulthood (Roux, Shattuck, 
Rast, Rava, & Anderson, 2015). The responsibility of navigating complex systems of care, 
coordinating care across systems, advocating for services, and collaboratively setting treatment 
goals frequently falls on family members. Parents generally assume these responsibilities but 
report inadequate support over the transition to adulthood. Furthermore, the existing research 
base and service system have largely neglected cultural differences in transition-related 
preferences and goals for adulthood. The proposed research aims to develop an innovative 
program to engage families in the process of creating and implementing a plan to support their 
child over the transition to adulthood. Individualized and culturally-responsive family 
engagement in transition planning during adolescence is expected to result in more sustained 
engagement with the autism service system into adulthood, which in turn may set up more 
positive trajectories of functional, behavioral, and health outcomes across the life course and 
decrease race/ethnicity-based service use disparities into adulthood. 
 
 
SECTION O:  COSTS/PAYMENTS 
YES* 
NO 
 
☐ 
☒ 
Are there any costs to subjects as a result of participating in this study?  
If YES, provide a description of the costs: 
☒ 
☐ 
Will subjects be compensated for participating in the study?  Compensation may 
include cash, checks, gift cards, lotteries, course credit, etc. Payments should be 
prorated to compensate subjects for time and procedures completed 
If YES, provide a description of the compensation:  
 

 
 
 
   
 
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Phase 1: Parents / primary caregivers, individuals on the autism (when they 
participate), and service providers will each receive a gift card worth $50 when 
they complete the qualitative interview. If an adolescent/young adult and 
caregiver both participate in separate interviews, they will each be compensated 
$50 (i.e., $100 total for the family). If only the caregiver participates, this 
individual will receive $50 (i.e., $50 total for the family). This compensation 
will be provided as gift cards to be distributed in-person, via mail, or 
electronically. 
 
Phase 2: Parents / primary caregivers will receive a gift card worth $30 for 
completing Time 1 measures.  
Parents / primary caregivers will receive a gift card worth $50 when they 
complete post-program data collection. Individuals on the autism will receive 
$30 for completing post-program exit interviews. (If an adolescent/young adult 
and caregiver both contribute post-program data, they will each be compensated 
(i.e., $80 total for the family). If only the parent/caregiver participates, this 
individual will receive $50 (i.e., $50 total for the family).  
This compensation will be provided as gift cards to be distributed in-person, via 
mail, or electronically.  
Service providers will not be compensated for participating in the exit interview. 
 
Families will not be compensated for participating in treatment sessions; rather, 
compensation will be given for providing research data. 
 
☐ 
☒ 
Will identifiable information be sent to Central University departments (e.g. 
Accounts Payable, Post Award Financial Operations, etc.) for payment 
purposes? If YES, this information must be disclosed in the consent form. 
 
SECTION P:  CONFIDENTIALITY OF DATA 
Describe how data will be stored (e.g. paper, electronic database, etc.) 
Electronic data, written transcripts, and audio recordings of interviews will be maintained in 
secured project files in the research office at Boston University (900 Commonwealth Ave, 2nd 
Floor, Boston, MA 02215). Files with identifying information will be maintained in a password 
protected electronic file separate from completed questionnaires or interview data, which will 
contain only identification codes. Electronic data will be kept on a secure server that can be 
accessed only by the PI and any authorized research staff. Hard copies of research-related 
materials (e.g., handwritten notes taken during the interviews) will be kept in a locked file 
cabinet in the research office. Audio recordings collected by BU investigators will be transferred 
to a password-protected secure network drive at BU and secure cloud storage (when interviews 
are conducted remotely by BU investigators), and will be deleted from the local laptops. 
Identifying information will be kept in a separate, locked cabinet in the research office. 
Identifying information about families who decline participation will be destroyed. Maintaining 

 
 
 
   
 
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all records in a locked file that is available only to research personnel will protect 
confidentiality. Only identification codes (i.e., no protected health information) will be used in 
presenting data in lectures, seminars, and papers. Participants will be given access to summaries 
of the study data if requested, after completion of the study. 
 
Interviews may be conducted using video conferencing, so alternative safeguards have been 
taken to ensure protection of confidentiality throughout these portions of the study. The host 
sends participants a secure link through which to access the meeting/session, and can require a 
password (provided by the host) to join the meeting; thus, families do not need to register for 
their own Zoom account. Zoom software clearly identifies the user to the host. Audio recordings 
collected by BU investigators will be transferred to a password-protected secure network drive at 
BU and secure cloud storage (when interviews are conducted remotely by BU investigators), and 
will be deleted from the local laptops. 
 
 
 
YES* 
NO 
 
☒ 
☐ 
Will you collect identifiable information? (e.g. names, social security numbers, 
addresses, telephone numbers, etc.). If YES, complete the box below. 
Describe the coding system that will be used to protect the information including who will 
have access to the code. Coding systems are used to: 1) protect the confidentiality of the research 
data and 2) allow the investigator to link subjects to their responses. Each subject is assigned a 
unique study ID at the beginning of the study. A separate document (key) should be maintained 
that links the names of the subjects to the study ID numbers. 
The identified data will only be accessed and analyzed by the researchers in the study. PI will use 
pseudonym to represent each participant. The file documenting the association between the 
pseudonym and real identity will only be stored in PI’s lab. 
 
YES* 
NO 
 
☐ 
☒ 
Will you share data with others outside of the study? If YES, complete the box 
below. 
Describe how data will be transferred and how confidentiality will be maintained (e.g. 
identifying information will not be sent outside, etc.): 
 
 
 
 
Describe how you will maintain the confidentiality of the data (e.g. locked cabinet, password-
protected files, encryption, etc.). Note: Confidentiality refers to the researcher’s agreement with 
the participant about how the subject’s identifiable private information will be handled, managed, 
and disseminated. For further assistance and/or access to resources regarding information security, 
please refer to the BU Information Security website. 
Electronic files with identifying information will be maintained in a password protected 
electronic file separate from completed questionnaires or interview data, which will contain only 
identification codes. Electronic data will be kept on a secure server that can be accessed only by 
the PI and any authorized research staff. Hard copies of completed questionnaires will contain 

 
 
 
   
 
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only identification codes (no identifying information) and will be kept in a locked cabinet. Hard 
copies of telephone screens will be kept in a separate locked cabinet. Electronic data collection 
will be entered directly into Qualtrics. Data entered into Qualtrics will only be accessible to 
research staff who have a username and password. Qualtrics uses secure socket layering (SSL) 
encryption technology and stores data on a secure, password protected server. No identifying 
information will be used when presenting findings. 
 
Per Boston University (BU) Record Retention Policy, records concerning human subjects must be 
retained for 7 years. As the investigator, you must also adhere to all applicable requirements as 
defined by regulatory agencies (e.g. FDA, etc.) or Sponsors. 
 
SECTION Q:  CERTIFICATE OF CONFIDENTIALITY 
In 2017 the NIH updated its policy for issuing Certificates of Confidentiality. Under the policy, 
all eligible research studies funded by the NIH are automatically issued a certificate of 
confidentiality. Investigators whose research is not funded or supported by the NIH may request 
and obtain from the NIH a Certificate of Confidentiality. Investigators who request and receive 
Certificates must follow the NIH and PHS policies governing such certifications. 
 
YES 
NO 
 
☐ 
☒ 
Is your research funded by the NIH and eligible for a Certificate of 
Confidentiality? 
☐ 
☒ 
If your research is not funded by the NIH, will you be applying for a Certificate 
of Confidentiality? 
 
SECTION R:  PRIVACY 
Describe how you will protect the privacy of subjects (e.g. where will consent procedures 
take place, if interviews or other interventions, where will these procedures take place) 
1. 
The location of data storage is PIs’ research lab at Boston University. Specifically, the 
research team has set up a secure Sharepoint site that can be accessed by both the BU and 
Lehigh research staff, and which serves as the repository for all study data. 
2. 
Only the research staff mentioned in this document will be allowed to access to study 
information. 
3. 
For Phase 1 (interviews), we expect that the majority of interviews will be held online via 
Zoom. However, participants may also choose to complete qualitative interviews via 
phone.  
4. 
For Phase 2, all data will be collected by the Boston University study team online via 
Qualtrics or via zoom/phone in order to separate data collection from the Arc providers. 
 
 
SECTION S:  MONITORING STUDY DATA 
How will data be monitored?  
Note: The Data and Safety Monitoring Plan should be tailored to the nature, size, and complexity 
of the research protocol, the expected risks of the research, and the type of subject population being 
studied. 

 
 
 
   
 
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☒ 
Principal Investigator 
☐ 
Monitor/Monitoring Group 
☐ 
Data and Safety Monitoring Board (DSMB) 
Note: The DSMB Charter must be submitted with this Application.  
For more information regarding a DSMB, please refer to the NIH website.  
 
Describe the plan for monitoring study data.  This should include a description of how data 
will be collected and analyzed as the project progresses to assure the appropriateness of the 
research, its design, and subject protections. 
Data monitoring will be conducted throughout the project period. As part of our weekly research 
meetings, Drs. Long and Orsmond will evaluate the progress of the study and review data 
quality, recruitment, and adverse events to identify any changes in participant risk. Dr. Long will 
assume primary responsibility for ensuring that protocols to ensure participant confidentiality are 
closely followed. In accordance with the IRB procedures, Dr. Long will monitor all research 
procedures to ensure that they conform to the approved IRB protocol. Any adverse events will be 
immediately reported to the Boston University IRB. 
 
 
SECTION T:  HIPAA 
Health Insurance Portability and Accountability Act 
YES* 
NO 
 
☐ 
☒ 
Is this research being conducted in a covered entity?  
The following BU CRC Departments are considered covered entities:  
• Sargent College Rehabilitation Services 
o Physical Therapy Center at the Ryan Center for Sports Medicine and 
Rehabilitation 
o Sargent Choice Nutrition Center 
• The Danielsen Institute 
• Boston University Health Plan 
*If YES, contact the IRB office for assistance. 
 
SECTION U: FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT 
(FERPA): FERPA is the federal law that protects the privacy of student education records.  
Research funded by the Department of Education or research conducted in educational institutions 
that receive funds from the Department of Education (for research or other purposes) must comply 
with FERPA. 
YES* 
NO 
 
☐ 
☒ 
Does this study involve collection of information from student 
school/university records? *If YES, refer to the following websites for 
guidance on FERPA: 
• http://www.bu.edu/researchsupport/compliance/human-subjects/ 
• http://www.bu.edu/reg/general-information/ferpa/ 
• http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html 

 
 
 
   
 
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If FERPA applies, you must complete the box below: 
In accordance with FERPA, written consent must be obtained to access student records. The 
consent must:  
• Specify the records that may be disclosed 
• State the purpose of the disclosure 
• Identify the person or class of parties to whom the disclosure can be made 
☐ YES 
(REQUIRED) 
I confirm that I will comply with the FERPA policy that is in place at the 
educational institution where I am conducting my research.  This includes, if 
applicable, the requirements for written agreement when requesting a waiver 
of consent for personally identifiable information.  If an agreement is 
required, this agreement must be submitted to the IRB. 
 
SECTION V:  PROTECTION OF PUPIL RIGHTS AMENDMENT (PPRA): 
PPRA is a federal law that affords certain rights to parents of minor students with regard to surveys 
that ask questions of a personal nature.  Research funded by the Department of Education or 
research conducted in educational institutions that receive funds (for research or other purposes) 
from the Department of Education must comply with the PPRA. 
YES* 
NO 
 
☐ 
☒ 
Does PPRA apply to this study? If YES, refer to the following websites for 
guidance:  
• http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html 
• http://www.bu.edu/researchsupport/compliance/human-subjects/ 
If PPRA applies, you must complete the box below: 
In accordance with PPRA, written parental consent must be obtained prior to subject’s 
participation in the study.  
☐ YES 
(REQUIRED) 
I confirm that I will comply with the PPRA policy that is in place at the 
educational institution where I am conducting my research.   
 
SECTION W:  CLINICAL TRIALS REGISTRATION: 
The Food Drug and Administration Amendments Act (known as FDAAA 801) requires that 
“applicable clinical trials” be registered and have results reported on clinicaltrials.gov. In addition, 
the International Committee of Medical Journal Editors (ICJME) and the National Institutes of 
Health (NIH) also have requirements for registration.  Please see box below to determine if your 
study requires registration in accordance with either FDAAA 801, ICJME, or NIH. 
YES 
NO 
FDAAA 801 Requirements 
☐ 
☒ 
Does your study meet the definition of an applicable clinical trial (ACT) and 
require registration AND results submission in accordance with FDAAA 801?  
ACTs include: 
• Trials of drugs and biologics: Controlled clinical investigations, other than 
phase 1 clinical investigations, of drugs or biological products subject to 
Food and Drug Administration (FDA) regulation 
• Trials of devices (see note): 1) Controlled trials with health outcomes of 
devices subject to FDA regulation, other than small feasibility studies, and 
2) pediatric post-market surveillance required by FDA  
 

 
 
 
   
 
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Note: If your study meets the requirement for registration and reporting, you 
must submit the National Clinical Trial (NCT) Identifier # to the IRB prior to 
IRB approval.  NCT #:  
 
YES 
NO 
ICMJE Requirements 
☐ 
☒ 
Does your study meet the definition of a clinical trial and require registration 
in accordance with ICMJE?  
 
Note:  If your study meets the requirement for registration, you must submit 
the National Clinical Trial (NCT) Identifier # to the IRB prior to IRB approval. 
NCT #: 
 
YES 
NO 
NIH Requirements 
☐ 
☒ 
Does your study meet the definition of an applicable clinical trial and require 
registration AND results submission in accordance with NIH?  
For more information on this policy please refer to:   
• NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information  
• Checklist 
Note:  If your study meets the requirement for registration and reporting, you 
must submit the National Clinical Trial (NCT) Identifier # to the IRB prior to 
IRB approval. NCT #: 
 
 
Certification / Signatures 
• By submitting this protocol I attest to the fact that all research activities to be implemented 
related to human subjects have been completely and accurately described herein. 
• I agree to conduct the describe research in an ethical manner.  
• I agree to comply with all institutional policies and procedures related to human subjects 
research and will not begin any human subjects research activities until I have obtained full 
approval from the IRB. 
• I agree to conduct the research as described in this protocol and not to make any changes 
(except to eliminate immediate harm to subjects) without first obtaining approval for the 
changes from the IRB.  
• I agree to immediately report any unanticipated problems involving risks to subjects or others, 
any subject complaints, and any incidents of non-compliance with the requirements of this 
protocol as soon as I become aware of them.  
• I agree to comply with any relevant HIPAA and FERPA regulations if applicable.  
• I verify that all those responsible for the design, conduct, or reporting of the proposed program, 
including at minimum, all Senior/key personnel in the grant application, have completed the 
financial 
interest 
disclosure 
forms 
and 
completed 
training 
as 
dictated 
at 
http://www.bu.edu/orc/coi/forms/, and returned the forms to   the Office for Research 
Compliance COI Unit.  NOTE: If anyone checked “yes” to any of the questions on either 
the FIND1 or NONFIND1 form, the IRB Director will contact the COI office to obtain 
the disclosure information. 

 
 
 
   
 
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PI Printed Name: Kristin Long 
 
PI Signature:  
 
 
 
 
 
Date: 02/08/2022 
 
 
Submission: This form can be completed, signed, scanned and submitted to the IRB at 
irb@bu.edu.   Faxed documents and handwritten materials are not accepted. Be sure to include all 
relevant attachments.   
 
 
 
 
FACULTY Research: 
 
The Department Chair signature is required: This application must be signed by the 
Department Chair for all faculty researchers.  If the PI is the Department Chair, then signature by 
the appropriate Dean is required. Department Chair signature is not required for student research.  
 
By signing this form you are indicating that you have reviewed the application, the 
faculty/staff person listed as PI on this protocol is a member of your department, hat he/she 
is qualified to serve as the PI for this study, he/she has the adequate resources, and the 
research utilizes acceptable practice for the discipline. 
 
Department Chair (print name): David Somers 
 
 
 
 
 
 
 
 
 
Department/School: Psychological & Brain Sciences / CAS  
 
 
 
 
  
 
 
 
 
 
 
        
Signature: 
 
  
 
 
 
  
 
Date:  
 
Feb 8, 2022 
 
 
 
  
 
 
STUDENT Research 
Student research: Student research must be signed by the faculty advisor AND the designated 
School IRB pre-reviewer (if applicable) PRIOR TO submission to the IRB.  Students should check 
with their School to determine if School IRB pre-review is required.  Students must submit a copy 
of their dissertation with the IRB Application  
 

 
 
 
   
 
40 
Version:  April 2022 
By signing this form, you are indicating that you have reviewed the application, that you 
agree to serve as the Co-PI for this study with the student and that you will be responsible 
for the ethical conduct of this student’s human subjects research.   
 
Faculty Advisor (print name): 
 
 
 
 
 
  
 
Signature: 
 
 
 
 
 
 
  
 
Date:  
 
 
 
 
  
 
IRB School Reviewer, if applicable (print name): 
 
 
 
 
 
  
 
Signature: 
 
 
 
 
 
 
  
 
Date:  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
   
 
41 
Version:  April 2022 
Statistical Analysis Plan 
 
To assess clinically-significant change in treatment targets and outcomes, we will use 
both anchor-based and distribution-based approaches. Regarding anchor-based approaches, we 
will assess changes on proposed treatment targets (parent self-efficacy and expectations for adult 
outcomes) and program outcomes (transition planning activities and attainment of personalized 
program goals) in relation to self-reported global assessment of change. Global assessments are 
considered to be sensitive to change and are obtained by asking participants to think back over a 
specific period of time (i.e., since before participation in Families FORWARD) and indicate the 
presence and direction of change in their functioning from that time to the present (i.e., 
improvement, decline, no change).We will use Pearson correlations to assess associations 
between global assessment ratings and pre/post-program change scores on treatment targets and 
outcomes. Regarding distribution-based approaches, we will compare pre- to post-program 
changes in treatment targets and program outcomes to measures of variability within the sample. 
We will complete these analyses using standard errors of measurement (SEM), standard 
deviations (SD), and effect sizes (ES). SEM of 1.0, SD of 0.50, and/or ES (Cohen’s d) of 0.20 
will be indicative of clinically-significant change. We will analyze qualitative exit interview data 
using applied thematic analysis. Although our sample is not large enough to reach saturation 
within each racial/ ethnic group, a nuanced analysis according to race/ethnicity is important for 
our research question that addresses feasibility, acceptability, and perceptions of program benefit 
across diverse participants. The goal of proof-of-concept testing is not to demonstrate thematic 
saturation, but rather, to inform the promise of an intervention to guide future work. We will 
conduct all analyses for the entire sample and again separately for each racial/ethnic group 
(Black, Latinx, Asian, and non-Latinx white), since outcomes may differ across groups. 
 
To assess acceptability, descriptive statistics (mean, median, standard deviation) will be 
calculated for quantitative acceptability ratings. Exit interview data about program usefulness 
and value will be evaluated using applied thematic analysis. Analyses will be conducted with the 
whole sample and separately for each racial/ethnic group. To assess feasibility, we will calculate 
the number of eligible participants who enrolled in the pilot trial. Retention will be presented 
descriptively as the average number of sessions completed and follow-up rates within each 
racial/ethnic group. To assess selective attrition, we will use t-tests and chi squares to evaluate 
the demographic and autism-related characteristics of families who complete the program vs. 
those who do not complete the program; these analyses will be conducted for the entire sample. 
To assess feasibility of the telehealth approach, we will capture technology issues during review 
of session recordings and will track the number of families who required a tablet to be loaned to 
them in order to participate in the program. 
 
To assess viability of research procedures and measures, rates of completion for pre- and 
post-program measures will be described descriptively. We will use t-tests and chi squares to 
evaluate the demographic and autism characteristics of families who complete the measures vs. 
those who are lost to follow up; these analyses will be conducted for the entire sample. To assess 
participant understanding of measures, missing data and inconsistent response patterns will be 
recorded. Data collection time will be calculated descriptively (mean, standard deviation, range); 
participant burden regarding completing study measures will be captured qualitatively during 
exit interviews and will be summarized using applied thematic analysis. Fidelity to the program 
manual will be assessed by evaluating session recordings against checklists of required 
components and calculating the percentage of required components present. 

 
Boston University Charles River Campus IRB 
 
Page 1 of 7 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
**All consent forms are stored on REDCap platform** 
 
Protocol Title: Development of a new family-focused transition program 
Principal Investigator: Kristin Long, Ph.D.  
Description of Study Population: Parents of adolescents and young adults on the autism 
spectrum 
Version Date: 6/30/2023 
 
Study Summary 
The purpose of this research study is to develop and assess the feasibility of a new program to 
support families of teens and young adults (youth) on the autism spectrum to plan for the future. 
Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) is a new 
parent-focused, individual telehealth program. The program includes information about the 
transition to adult life, skills to help work through this transition, and guidance on working toward 
your family’s individual goals for the future. 
 
Parents will take part in 6 to 7 sessions (60-75 minutes each) led by a program coach to build 
skills and plan for the future. Youth can choose to participate in portions of 1, 2, or 3 sessions, 
along with their parent. Parents will take a survey before and after the program, give feedback 
after each session, and participate in an exit interview at the end of the program. Youth can take 
a survey and do an exit interview at the end of the program. 
 
Introduction 
Please read this form carefully. Our study team wants to provide you with important information 
about taking part in a research study. If any details about this study or information on this consent 
form seem unclear, please let us know. We are happy to answer any questions that may arise. If 
you agree to take part in this study, we will ask you to indicate your willingness to continue on to 
the survey. You will have the option to download a copy of this consent form at the end. You also 
may request a copy of the consent form to be emailed to you after you complete it.  
  
The person in charge of this study is Kristin Long, PhD. Dr. Long can be reached by telephone at 
617-358-4296, or by email at kalong@bu.edu. We will refer to this person as the “researcher” 
throughout this form.  
 
What should I know about a research study? 
Participation in research is voluntary, which means that it is something for which you volunteer. 
It is your choice to participate in the study, or not to participate. If you choose to participate now, 

 
Boston University Charles River Campus IRB 
 
Page 2 of 7 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
you may change your mind and stop participating later. If you decide not to participate, that 
decision will not result in any penalty or loss of benefits to which you are otherwise entitled.  
 
Why is this study being done? 
The purpose of this study is to develop a new program that supports families of youth on the 
autism spectrum to plan for the transition to adult life. Many families describe this transition to 
adult life as challenging. Parents often express a need for additional support, skills, and 
information while helping their youth transition to adult life. As a result, we have developed the 
Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) program 
to help families of youth on the autism spectrum build skills and learn information that will help 
them plan for the future. This program includes 6 to 7 sessions for the parents. Youth may also 
choose to participate in portions of 1, 2, or 3 sessions (optional). We are conducting a small trial 
of this new program and to hear families’ feedback about how to improve the program.  
 
We are asking you to take part in this study because you are parent of a youth (aged 14-21), who 
lives in the state of Massachusetts and are fluent in English.  
 
About 20 subjects will take part in this research study at Boston University. 
 
Who is Funding the Study?  
 
The study is funded by The Deborah Munroe Noonan Memorial Research Fund. 
 
How long will I take part in this research study? 
We expect that you will be in this research study for approximately 3 months.   
 
What will happen if I take part in this research study? 
If you agree to take part in this study, we will ask you to sign the consent form before we conduct 
any study procedures. If you choose to be part of this study, you will be asked to complete survey 
before and after participating in the Families FORWARD program. The survey can be completed 
on a computer, laptop, or tablet. If you need assistance, a Boston University researcher can help 
you complete it over the phone. After you complete this first set of survey (Time 1), you will be 
asked to participate in the Families FORWARD program, which includes 6 to 7 sessions online 
with a coach. After each session, you will complete a feedback form about the helpful and 
unhelpful aspects of the session and how we can improve it. At the end of the program, you will 
complete a second set of survey and participate in an exit interview (Time 2). Youth may 
participate in portions of sessions 1, 2, or 3 and complete a feedback form for the attended 
sessions. They can also take a short survey and do an exit interview at the end of the program 
(Time 2).  
 
 

 
Boston University Charles River Campus IRB 
 
Page 3 of 7 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
Time 1 Survey Details 
Completing the survey will take approximately 70 minutes. This survey will ask you to tell us 
about your family (background information, family communication about planning for the 
future, and plans for youth’s adult life); your youth on the autism spectrum (autism severity); 
and yourself (your experience with future planning for youth, barriers to future planning, and 
knowledge of services). 
 
Pre-Session Phone Call 
Once you have completed the survey at Time 1, a coach will reach out to you to share more 
information about the program, learn about your youth’s interest in participating, and answer 
any other questions you may have about the program. In addition, you and the coach will also 
work together to discuss technology required to participate. In this conversation you will 
discuss how to set up Zoom on a computer, tablet, or smartphone. This phone call will take 15 
minutes or less and can be scheduled at a time that is convenient for you.  
 
Families FORWARD Program (6 to 7 sessions) 
Parents will participate in an online program consisting of 6 to 7 sessions, which will take 
approximately 3 months to complete. Each session is 60-75 minutes long. During the sessions, 
parents will discuss their future goals and may participate with their youth in three sessions to 
learn about their desires, they may also communicate with others to refine their goals, learn 
about adult service systems, and engage in problem-solving. Parents will practice skills and 
work on their identified goal between sessions. After each session, parents and youth will 
complete a brief feedback form. 
 
Time 2 Survey and Exit Interview 
At the end of the program (approximately three months after you start the study), we will ask 
you to complete another set of survey and an exit interview. The survey will take about 60 
minutes to complete and ask you about your family (family communication about future 
planning, and plans for your youth’s adult life) and yourself (your experience with future 
planning for youth, barriers to future planning, and knowledge of services). The exit interview 
will take 20-30 minutes, where you will provide feedback about your experiences participating 
in the program.  
 
What are the risks of taking part in this research study? 
 
Risks of Completing Tasks 
Thinking about the future may be challenging at times. You may be uncomfortable with some of 
the questions and topics we will ask about. You do not have to answer any questions or 
participate in any sessions that make you feel uncomfortable. 
 

 
Boston University Charles River Campus IRB 
 
Page 4 of 7 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
If you or your youth decide to withdraw from the study, we ask that you let us know. There will 
be no penalty or loss of benefits to which you are entitled. If you decide to withdraw from the 
study, the information that you and your child have already provided will be kept confidential. 
 
If you withdraw from the study, you may still receive services for yourself or your family 
members (including the youth) if you choose not to participate. Your decision will not affect the 
care you receive now or in the future. Participation in this research is voluntary and you may 
leave or stop the study at any time without penalty and without affecting your services. If you 
would like to stop participating in this research, please let us know. 
 
Questionnaire/Survey Risks 
You may feel emotional or upset when answering some of the questions. Tell the interviewer at 
any time if you want to take a break or stop the interview.  
 
You may be uncomfortable with some of the questions and topics we will ask about.  You do not 
have to answer any questions that make you feel uncomfortable. 
 
Loss of Confidentiality 
The main risk of allowing us to use and store your information for research is a potential loss of 
privacy.  We will protect your privacy by labeling your information with a code and keeping the 
key to the code in a password-protected computer. 
 
You will be informed of any significant new findings developed during the course of this research 
which may affect your willingness to continue participation. 
 
Mandated Reporting 
If, during your participation in this study, we have reasonable cause to believe that 
individual/child/elder abuse is occurring, we must report this to authorities as required by law. 
The researcher will make every reasonable effort to protect the confidentiality of your research 
information. However, it might be possible that a civil or criminal court might demand the release 
of identifiable research information. 
 
Reporting Suicidal Risk: If, during your participation of this study, we have reason to believe that 
you are at risk for being suicidal or otherwise harming yourself, we are required to take the 
necessary actions. This may include notifying your doctor, your therapist, or other individuals.  If 
this were to occur, we would not be able to assure confidentiality. 
 
Reporting Sexual Misconduct, Sexual Harassment and/or Sexual Assault:  
If you are a member of the Boston University community and you report sexual misconduct to 
study personnel, including as part of study procedures, we are mandated to report the 
misconduct to the Boston University Title IX Coordinator. Members of the Boston University 

 
Boston University Charles River Campus IRB 
 
Page 5 of 7 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
community include students, faculty, staff, affiliates, visitors, applicants for admission or 
employment, and independent contractors. Sexual misconduct includes sexual assault, sexual 
harassment, dating violence, domestic violence, stalking, and sexual exploitation. If you have 
questions, please review the BU Title IX policy, contact the Title IX coordinator, the Study 
Investigator, or the IRB Office.  
 
Are there any benefits from being in this research study? 
The family may perceive direct benefits, such as skill development, knowledge, and a greater 
clarity about their plans for the future. The primary goal of this research is to collect 
information about the scientific questions asked in this study. Through your participation, you 
may help the investigators learn about how to support youth on the autism spectrum and/or 
their families.   
 
Study Participation and Early Withdrawal 
Taking part in this study is your choice.  You are free not to take part or to withdraw at any time 
for any reason. No matter what you decide, there will be no penalty or loss of benefit to which 
you are entitled. If you decide to withdraw from this study, the information that you have already 
provided will remain in the data set and be kept confidential. 
 
Audio/Video Recording 
We would like to video record you during this study. We would like to audio record the exit 
interviews conducted at the end of the program. If you are video- and audio-recorded, it will be 
possible to identify you. We will store these recordings on our computer and only approved 
study staff will have access to the recordings. We will label these recordings with a code 
instead of your name. The key to the code connects your name to your recording.  The 
researcher will keep the key to the code in a password-protected computer. According to 
Boston University’s policies, recordings will be stored for 7 years.  
 
Do you agree to allow us to audio and video- and audio-record you during this study?  
  
______YES  
  
______NO  
  
_______ INITIALS  
 
How Will You Keep My Study Records Confidential? 
Storing Study Information for Future Use  
We will keep the records of this study confidential by using a code to identify your study 
information instead of your name. We will make every effort to keep your records 
confidential.  However, there are times when federal or state law requires the disclosure of 
your records. The key to the code that links your name to the information you provide us will 
be stored in a password-protected on our secure limited access network drive. However, there 
are times when federal or state law requires the disclosure of your records.  

 
Boston University Charles River Campus IRB 
 
Page 6 of 7 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
 
The following people or groups may review your study records for purposes such as quality 
control or safety: 
• The Researcher and any member of their research team 
• The Institutional Review Board at Boston University. The Institutional Review Board is a group 
of people who review human research studies for safety and protection of people who take 
part in the studies. 
• The sponsor or funding agency for this study 
• Federal and state agencies that oversee or review research 
• Central University Offices  
  
The results of this research study may be published or used for teaching. We will not include 
identifiable information on data that are used for these purposes. 
 
Future Contact  
We may want to contact you in the future either to follow-up to this study or to see if you are 
interested in other studies taking place at Boston University.    
  
May we contact you in the future?  
  
______YES  
  
______NO  
  
_______ INITIALS 
 
Will I get paid for taking part in this research study?   
Parents and their youth can receive gift cards worth up to $110 for completing the survey at 
the beginning and after the end of the program. Parents will receive a $30 gift card for 
completing the Time 1 survey, and a $50 gift card for completing the Time 2 survey and exit 
interview. Youth will receive a $30 gift card for completing the Time 2 survey and exit 
interview. The gift cards will be sent via email. 
 
What will it cost me to take part in this research study? 
There are no costs to you for taking part in this research study. 
 
What alternatives are available? 
You may choose not to take part in this research study. 
 
ClinicalTrials.Gov 
A description of this clinical trial will be available on https://clinicaltrials.gov/. This website will 
not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time. 
 

 
Boston University Charles River Campus IRB 
 
Page 7 of 7 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
Who do I ask if I have questions or concerns about this research study? 
Please call us with any concerns or questions about the research, or any research-related 
problems:  
Kristin Long, PhD (Principal Investigator)  
Phone (617-358-4296)  
Email (kalong@bu.edu)  
Availability: Weekdays 9am-5pm 
 
If you have questions about your rights as a research participant, or if you have any complaints 
or concerns and want to speak with someone independent of the research team, you may contact 
the Boston University Charles River Campus IRB at 617-358-6115. The IRB Office webpage has 
information where you can learn more about being a participant in research, and you can also 
complete a Participant Feedback Survey. 
 
Statement of Consent: I have read this information and have been given the chance to 
contact the researchers to ask questions. I agree to participate in the study.  
 
                (check box to note consent)  
 
Statement of Consent: I have also read this information and have been given the chance to 
contact the researchers to ask questions about my youth’s participate in the study. I am aware 
that the research team will complete a consent or assent with my child before including them in 
research. I agree to have my child on the autism spectrum participate in the program.  
 
               (check box to note consent for your child)  
 
 
 

 
Boston University Charles River Campus IRB 
 
Page 1 of 6 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
*All consent forms are stored on REDCap platform* 
 
Protocol Title: Development of a new family-focused transition program 
Principal Investigator: Kristin Long, Ph.D.  
Description of Study Population: Parents interested in future planning with their adolescent 
and young adult on the autism spectrum 
Version Date: 6/30/2023 
 
Study Summary 
The purpose of this research study is to develop and assess the feasibility of a new program to 
support families of teens and young adults (youth)on the autism spectrum to plan for the 
future. Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) is 
a new parent-focused, individual telehealth program. The program includes information about 
the transition to adult life, skills to help work through this transition, and guidance on working 
toward your family’s individual goals for the future. 
 
Parents will take part in 6 to 7 sessions (60-75 minutes each) led by a program coach to build 
skills and plan for the future. Youth can choose to participate in portions of 1, 2, or 3 sessions, 
along with their parent. Parents will take a survey before and after the program, give feedback 
after each session, and participate in an exit interview at the end of the program. Youth can take 
a survey and do an exit interview at the end of the program. 
 
Introduction 
Our study team wants to provide you with important information about taking part in a research 
study. If any details about this study or information on this consent form seem unclear, please 
let us know. We are happy to answer any questions that may arise. If you agree to take part in 
this study, we will ask you to verbally consent your willingness to participate in the study. We will 
provide you a copy of this verbal consent form.  
  
The person in charge of this study is Kristin Long, PhD. Dr. Long can be reached by telephone at 
617-358-4296, or by email at kalong@bu.edu. We will refer to this person as the “researcher” 
throughout this form.   
 
What should I know about a research study? 
Participation in research is voluntary, which means that it is something for which you volunteer. 
It is your choice to participate in the study, or not to participate. If you choose to participate now, 
you may change your mind and stop participating later. If you decide not to participate, that 
decision will not result in any penalty or loss of benefits to which you are otherwise entitled.  

 
Boston University Charles River Campus IRB 
 
Page 2 of 6 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
 
 
Why is this study being done? 
The purpose of this study is to develop a new program that supports families of youth on the 
autism spectrum to plan for the transition to adult life. Many families describe this transition to 
adult life as challenging. Parents often express a need for additional support, skills, and 
information while helping their youth transition to adult life. As a result, we have developed the 
Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) program 
to help families of youth on the autism spectrum build skills and learn information that will help 
them plan for the future. This program includes 6 to 7 sessions for the parents. Youth may also 
choose to participate in portions of 1, 2, or 3 sessions (optional). We are conducting a small trial 
of this new program and to hear families’ feedback about how to improve the program.  
 
We are asking you to take part in this study because you are a youth (aged 14-21), whose parent 
has agreed to participate in the program.  
 
About 20 subjects will take part in this research study at Boston University. 
 
Who is Funding the Study?  
 
The study is funded by The Deborah Munroe Noonan Memorial Research Fund. 
 
How long will I take part in this research study? 
We expect that you will be in this research study for approximately 3 months.  During this time, 
if you choose to participate with your parent, we will ask you to attend 1, 2, or 3 online.  
 
What will happen if I take part in this research study? 
If you agree to take part in this study, we will ask you for your verbal consent before we conduct 
any study procedures. If you choose to be part of this study, you will be asked to participate with 
your parent in the Families FORWARD program for portions of 1, 2, or 3 sessions online with a 
coach. After each session, you will complete a feedback form about the helpful and unhelpful 
aspects of the session and how we can improve it. At the end of the program, you will complete 
a survey and participate in an exit interview.  
 
Families FORWARD Program (6 to 7 sessions) 
Your parent will participate in an online program of 6 to 7 sessions over 3 months. You can 
choose to participate in portions of 1, 2, or 3 sessions, each lasting 30 minutes or less. During 
these sessions, you and your parent will communicate and plan for the future with a coach’s 
help. In other sessions, your parents will develop skills such as goal-setting, navigating service 
systems, and problem-solving. For each of the sessions you attend, we will ask you to complete 
a feedback form.  

 
Boston University Charles River Campus IRB 
 
Page 3 of 6 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
 
End of Program Survey and Interview  
At the end of the program, which is three months after you started the program, we will ask 
you to complete a short survey and participate in an exit interview. This will take about 20-30 
minutes to complete. In the survey and the exit interview, we will ask you to provide feedback 
about your experiences participating in the program. 
 
What are the risks of taking part in this research study? 
 
Risks of Completing Tasks 
Thinking about the future may be challenging at times. You may be uncomfortable with some of 
the questions and topics we will ask about. You do not have to answer any questions or 
participate in any sessions that make you feel uncomfortable. 
 
If you decide to withdraw from the study, we ask that you let us know. There will be no penalty 
or loss of benefits to which you are entitled. If you decide to withdraw from the study, the 
information that you have already provided will be kept confidential. 
 
If you withdraw from the study, you may still receive services for yourself or your family 
members. Your decision will not affect the care you receive now or in the future. Participation 
in this research is voluntary and you may leave or stop the study at any time without penalty 
and without affecting your services. If you would like to stop participating in this research, 
please let us know. 
 
Questionnaire/Survey Risks 
You may feel emotional or upset when answering some of the questions. Tell the interviewer at 
any time if you want to take a break or stop the interview.  
 
You may be uncomfortable with some of the questions and topics we will ask about.  You do not 
have to answer any questions that make you feel uncomfortable. 
 
Loss of Confidentiality 
The main risk of allowing us to use and store your information for research is a potential loss of 
privacy.  We will protect your privacy by labeling your information with a code and keeping the 
key to the code in a password-protected computer. 
 
You will be informed of any significant new findings developed during the course of this research 
which may affect your willingness to continue participation. 
 
 
 

 
Boston University Charles River Campus IRB 
 
Page 4 of 6 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
Mandated Reporting 
If, during your participation in this study, we have reasonable cause to believe that 
individual/child/elder abuse is occurring, we must report this to authorities as required by law. 
The researcher will make every reasonable effort to protect the confidentiality of your research 
information. However, it might be possible that a civil or criminal court might demand the release 
of identifiable research information. 
 
Reporting Suicidal Risk: If, during your participation of this study, we have reason to believe that 
you are at risk for being suicidal or otherwise harming yourself, we are required to take the 
necessary actions. This may include notifying your doctor, your therapist, or other individuals.  If 
this were to occur, we would not be able to assure confidentiality. 
 
Reporting Sexual Misconduct, Sexual Harassment and/or Sexual Assault:  
If you are a member of the Boston University community and you report sexual misconduct to 
study personnel, including as part of study procedures, we are mandated to report the 
misconduct to the Boston University Title IX Coordinator. Members of the Boston University 
community include students, faculty, staff, affiliates, visitors, applicants for admission or 
employment, and independent contractors. Sexual misconduct includes sexual assault, sexual 
harassment, dating violence, domestic violence, stalking, and sexual exploitation. If you have 
questions, please review the BU Title IX policy, contact the Title IX coordinator, the Study 
Investigator, or the IRB Office.  
 
Are there any benefits from being in this research study? 
The family may perceive direct benefits, such as skill development, knowledge, and a greater 
clarity about their plans for the future. The primary goal of this research is to collect 
information about the scientific questions asked in this study. Through your participation, you 
may help the investigators learn about how to support youth on the autism spectrum and/or 
their families.   
 
Study Participation and Early Withdrawal 
Taking part in this study is your choice.  You are free not to take part or to withdraw at any time 
for any reason. No matter what you decide, there will be no penalty or loss of benefit to which 
you are entitled. If you decide to withdraw from this study, the information that you have already 
provided will remain in the data set and be kept confidential. 
 
Audio/Video Recording 
We would like to video record you during this study. We would like to audio record the exit 
interviews conducted at the end of the program. If you are video- and audio-recorded, it will be 
possible to identify you. We will store these recordings on our computer and only approved 
study staff will have access to the recordings. We will label these recordings with a code 
instead of your name. The key to the code connects your name to your recording.  The 

 
Boston University Charles River Campus IRB 
 
Page 5 of 6 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
researcher will keep the key to the code in a password-protected computer. According to 
Boston University’s policies, recordings will be stored for 7 years.  
 
Do you agree to allow us to audio and video- and audio-record you during this study?  
  
______YES  
  
______NO  
  
_______ Study Staff Initials (for verbal consent)   
  
  
  
  
  
  
  
  
  
  
  
is provided)  
How Will You Keep My Study Records Confidential? 
Storing Study Information for Future Use  
We will keep the records of this study confidential by using a code to identify your study 
information instead of your name. We will make every effort to keep your records 
confidential.  However, there are times when federal or state law requires the disclosure of 
your records. The key to the code that links your name to the information you provide us will 
be stored in a password-protected on our secure limited access network drive. However, there 
are times when federal or state law requires the disclosure of your records.  
 
The following people or groups may review your study records for purposes such as quality 
control or safety: 
• The Researcher and any member of their research team 
• The Institutional Review Board at Boston University. The Institutional Review Board is a group 
of people who review human research studies for safety and protection of people who take 
part in the studies. 
• The sponsor or funding agency for this study 
• Federal and state agencies that oversee or review research 
• Central University Offices  
  
The results of this research study may be published or used for teaching. We will not include 
identifiable information on data that are used for these purposes. 
 
Future Contact  
We may want to contact you in the future either to follow-up to this study or to see if you are 
interested in other studies taking place at Boston University.    
  
May we contact you in the future?  
  
______YES  
  
______NO  
  
_______ Study Staff Initials (for verbal consent   
  
  
  
  
  
  
  
  
  
  
  
is provided)  
Will I get paid for taking part in this research study?   
You can receive $30 for completing the survey and exit interview end at the program. The gift 
cards will be sent via email.  

 
Boston University Charles River Campus IRB 
 
Page 6 of 6 
Consent Form Template; Version date:  September 2021 
Study Title:  Development of a new family-focused transition program 
IRB Protocol Number: 6444E 
 
Consent Form Valid Date: 8/21/2023 
Study Expiration Date:  04/18/2024 
 
 
 
What will it cost me to take part in this research study? 
There are no costs to you for taking part in this research study. 
 
What alternatives are available? 
You may choose not to take part in this research study. 
 
ClinicalTrials.Gov 
A description of this clinical trial will be available on https://clinicaltrials.gov/. Law. This website 
will not include information that can identify you. At most, the website will include a summary 
of the results. You can search this website at any time. 
 
Who do I ask if I have questions or concerns about this research study? 
Please call us with any concerns or questions about the research, or any research-related 
problems:  
Kristin Long, PhD (Principal Investigator)  
Phone (617-358-4296)  
Email (kalong@bu.edu)  
Availability: Weekdays 9am-5pm 
 
If you have questions about your rights as a research participant, or if you have any complaints 
or concerns and want to speak with someone independent of the research team, you may contact 
the Boston University Charles River Campus IRB at 617-358-6115. The IRB Office webpage has 
information where you can learn more about being a participant in research, and you can also 
complete a Participant Feedback Survey. 
 
Statement of Consent  
I have heard the information in this consent form including risks and possible benefits.  I have been 
given the chance to ask questions.  My questions have been answered to my satisfaction, and I 
agree to participate in the study.   
 
Signature:  
  
I agree to participate in this study:  
  
____Yes             ____No                
  
Study Staff Completing Consent Form (if applicable): ___________________________  
  
Date Consent Form Completed:_______________________