Examining the Impact of Family Connectors
Phase: NA
Conditions: Caregiver Stress Syndrome
Sponsor: NYU Langone Health

 
 
Official Title: 
Examining the Impact of Family Connectors 
NCT Number: 
NCT05195489 
Study Number: 
s21-01486 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
February 6, 2024 
 
 

Study number: s21-01486 
 
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EXAMINING THE IMPACT OF FAMILY CONNECTORS 
A study of 96 family members enrolled in Family Connectors (n=48) or a comparison condition (n=48).    
 
 
Principal Investigator: 
 
Kimberly Hoagwood, PhD, Cathy and Stephen Graham 
Professor of Child and Adolescent Psychiatry 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor, Room 310 
New York, NY 10016 
Phone:646-754-4888 
Email: Kimberly.hoagwood@nyulangone.org 
 
Mary McKay  
Vice Provost of Interdisciplinary Initiatives of the Brown School at 
Washington University 
Phone: 314-935-6693 
Email: mary.mckay@wustl.edu 
 
Additional Investigators: 
Nicole Davies 
Research Associate  
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 202-669-4540 
Email: Nicole.Davies@nyulangone.org  
 
Priscilla Shorter 
Project Coordinator/Parent Partner 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor, Room 333 
New York, NY 10016 
Phone: 646-754-5129 
Email: Priscilla.Shorter@nyulangone.org 
 
Paige Cervantes, PhD, BCBA 
Clinical Assisstant Professor 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 646-754-7243 
Email: paige.cervantes@nyulangone.org 
 
Lawrence A. Palinkas, Ph.D. 
Project Consultant 
Clinical Professor 
Herbert Wertheim School of Public Health and Longevity 
Science 
University of California, San Diego 
9500 Gilman Drive, M/C 0725 

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La Jolla, CA 92093 
Phone: 858-534-8466 
Email: lapalinkas@ucsd.edu 
 
Charlotte Gendler 
Research Associate  
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 424-285-3488 
Email: Charlotte.Gendler@nyulangone.org  
 
Fei Guo 
Associate Research Scientist 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 212-786-2893 
Email: Fei.Guo@nyulangone.org 
 
Dana Seag 
Project Coordinator 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 646-754-4917 
Email: Dana.Seag@nyulangone.org 
 
NYULMC Study Number: 
S12-01116 
Funding Sponsor:  
P50MH113662 
Study Locations & Roles 
Washington University will be responsible for generating GUID 
IDs, that are needed for reporting to the National Data 
Archives. Wash U is not recruiting participants. 
 
NYU is responsible for all other study activity. 
 
 
Initial version: 2021.09.15 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study number: s21-01486 
 
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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), any other applicable US government research regulations, and 
institutional research policies and procedures. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the study participants. All personnel involved in the conduct of this study have completed 
Human Subjects Protection Training. 
 
 

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Table of Contents 
 
PROTOCOL SUMMARY .............................................................................................................................. 1 
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 2 
1 
KEY ROLES ......................................................................................................................................... 2 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 4 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ................................................................ 4 
2.2 
RATIONALE .................................................................................................................................... 4 
2.3 
POTENTIAL RISKS & BENEFITS ........................................................................................................ 4 
2.3.1 
Known Potential Risks ............................................................................................................. 5 
2.3.2 
Known Potential Benefits ........................................................................................................ 5 
3 
OBJECTIVES AND PURPOSE ........................................................................................................... 5 
3.1 
PRIMARY OBJECTIVE ...................................................................................................................... 5 
3.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ...................................................................................... 5 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 6 
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................... 6 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................... 6 
5.1 
INCLUSION CRITERIA ...................................................................................................................... 6 
5.2 
EXCLUSION CRITERIA ..................................................................................................................... 6 
5.3 
VULNERABLE SUBJECTS ................................................................................................................. 6 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION ............................................................................ 6 
5.5 
DURATION OF STUDY PARTICIPATION .............................................................................................. 6 
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES .................................................................................. 7 
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION .................................................................................. 7 
5.7.1 
Reasons for Withdrawal or Termination .................................................................................. 7 
5.7.2 
Handling of Participant Withdrawals or Termination ............................................................... 7 
5.7.3 
Premature Termination or Suspension of Study ..................................................................... 7 
6 
STUDY SCHEDULE............................................................................................................................. 8 
6.1 
ENROLLMENT/BASELINE ................................................................................................................. 8 
6.2 
INTERMEDIATE VISITS ..................................................................................................................... 8 
6.3 
FINAL STUDY VISIT ......................................................................................................................... 8 
6.4 
WITHDRAWAL VISIT ........................................................................................................................ 8 
7 
STUDY PROCEDURES/EVALUATIONS ............................................................................................ 8 
7.1 
QUESTIONNAIRE ADMINISTRATION .................................................................................................. 8 
SEE THE APPENDIX FOR A COPY OF THE MEASURES. ..................................................................................... 9 
7.2 
PROCEDURES/EVALUATIONS .......................................................................................................... 9 
SEE THE APPENDIX FOR A COPY OF THE MEASURE. ....................................................................................... 9 
8 
SAFETY AND ADVERSE EVENTS ..................................................................................................... 9 
8.1 
DEFINITIONS .................................................................................................................................. 9 
8.2 
RECORDING OF ADVERSE EVENTS ................................................................................................ 10 
8.3 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ................................. 10 
8.3.1 
Investigator reporting: notifying the IRB ................................................................................ 10 
9 
STUDY OVERSIGHT ......................................................................................................................... 11 
10 
STATISTICAL CONSIDERATIONS .................................................................................................. 11 
10.1 
STUDY HYPOTHESES .................................................................................................................... 11 

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10.2 
SAMPLE SIZE DETERMINATION ...................................................................................................... 12 
10.3 
STATISTICAL METHODS ................................................................................................................ 12 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 12 
12 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 12 
12.1 
ETHICAL STANDARD ..................................................................................................................... 12 
12.2 
INSTITUTIONAL REVIEW BOARD ..................................................................................................... 12 
12.3 
INFORMED CONSENT PROCESS .................................................................................................... 13 
12.3.1 
Consent/Assent and Other Informational Documents Provided to Participants ............... 13 
12.3.2 
Consent Procedures and Documentation ......................................................................... 13 
12.4 
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................................... 13 
13 
DATA HANDLING AND RECORD KEEPING ................................................................................... 14 
13.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 14 
13.2 
STUDY RECORDS RETENTION ....................................................................................................... 15 
13.3 
PROTOCOL DEVIATIONS ............................................................................................................... 15 
13.4 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 15 
14 
STUDY FINANCES ............................................................................................................................ 15 
14.1 
FUNDING SOURCE ........................................................................................................................ 15 
14.2 
COSTS TO THE PARTICIPANT ......................................................................................................... 15 
14.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 15 
15 
STUDY ADMINISTRATION ............................................................................................................... 16 
15.1 
STUDY LEADERSHIP ..................................................................................................................... 16 
16 
CONFLICT OF INTEREST POLICY .................................................................................................. 16 
17 
ATTACHMENTS ................................................................................................................................ 17 
 
 

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List of Abbreviations 
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
FFR 
Federal Financial Report 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIH 
National Institutes of Health 
NYC H+H 
New York City Health + Hospitals 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QI 
Quality Improvement 
SAE 
Serious Adverse Event/Serious Adverse Experience 
US 
United States 
 
 
 
 
 
 
 

IMPACT Protocol 
 
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Protocol Summary 
Title 
Examining the Impact of Family Connectors 
Short Title 
Family Connectors 
Brief Summary 
This study will examine the impact of Family Connectors amongst 96 family 
members of adolescents/young adults with first episode psychosis who were 
discharged from OnTrack. 
Objectives 
The study objectives are to examine the association between involvement in 
Family Connectors, a manualized peer-to-peer support and education 
program for family members of adolescents or young adults with symptoms of 
first episode psychosis, and feelings of empowerment, self-efficacy and social 
support. A total of 96 family members will be enrolled in this study, and will be 
enrolled in either Family Connectors + a packet of community resources or 
the community resource alone. Outcomes consist of the family member’s 
feelings of self-efficacy, connection to services and supports, caregiving 
strain, satisfaction, and perceptions of adolescent/young adult functional 
outcomes at school and work. 
Methodology 
RCT with data collection and baseline (T1), follow-up (one-month post-
baseline, T2) and posttest (six months past T2xx). 
Endpoint 
The primary endpoint of the study is when data collection is completed for 96 
participants. 
Study Duration 
Approximately 2 years. 
Participant Duration 
Approximately 9 months from enrollment to completion of posttest data. 
Population 
96 adults who are (1) English speaking, (2) 18 years of age or older, (3) a 
family member of an adolescent/young adult with first episode psychosis who 
was discharged from OnTrack. 
Study Sites 
The participating site is the NYU Langone School of Medicine and 
Washington University.  
Number of participants 
96 family members will be enrolled at NYU Langone School of Medicine  
Statistical Analysis 
Descriptive analyses will be conducted to calculate means and standard 
deviations for continuous data and numbers and percentages for 
dichotomous data. Bivariate and multivariate analyses will examine between 
and within group differences from baseline to posttest. 
 
 
 

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Schematic of Study Design 
 
 
 
 Enrollment 
 
 
 
Consent   
 
 
 
 
 
Baseline 
Assessment  
(T1) 
 
 
 
 
 
Check-in  
Call 
 
 
 
 
 
Follow-up 
Assessment  
(T2) 
 
 
 
  
 
Intervention 
 
 
  
 
 
 
 
 
 
 
Posttest (T3) 
 
 
 
A staff member will read a study script to family members who have a relative 
pending discharge from OnTrack. If a family member signs the provided contact 
form with their information, they will be contacted by a research team member. 
 
A member of the research staff will contact interested potential participants, 
describe the study in greater detail, and secure informed consent via REDCap. 
One-month post-baseline, family members will complete an additional 
assessment via REDCap. Participants will be randomized at the participant level 
to receive the active intervention or comparison condition.  
Active Intervention  
Family members (n=48) 
participate in Connectors by 
phone and receive a packet of 
resources 
Final Assessments 
 Family members complete 
Posttest measures in REDCap at 
seven months post-baseline 
 Comparison Condition 
Family members (n=48) receive 
a packet of resources 
After consenting, family members will complete a baseline assessment via 
REDCap. 
Two weeks post-baseline, family members will receive a check-in call from the 
research team to schedule a follow-up assessment. 

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1 Key Roles 
 
Kimberly Hoagwood, PhD, Cathy and Stephen Graham Professor of Child and Adolescent Psychiatry 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor, Room 310 
New York, NY 10016 
Phone: 646-754-4888 
Email: Kimberly.hoagwood@nyulangone.org 
 
Nicole Davies 
Research Associate  
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 202-669-4540 
Email: Nicole.Davies@nyulangone.org  
 
Priscilla Shorter 
Project Coordinator/Parent Partner 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor, Room 333 
New York, NY 10016 
Phone: 646-754-5129 
Email: Priscilla.Shorter@nyulangone.org 
 
Lawrence A. Palinkas, Ph.D. 
Project Consultant 
Clinical Professor 
Herbert Wertheim School of Public Health and Longevity Science 
University of California, San Diego 
9500 Gilman Drive, M/C 0725 
La Jolla, CA 92093 
Phone: 858-534-8466 
Email: lapalinkas@ucsd.edu 
 
Charlotte Gendler 
Research Associate  
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 424-285-3488 
Email: Charlotte.Gendler@nyulangone.org  
 
Fei Guo 
Associate Research Scientist 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 212-786-2893 
Email: Fei.Guo@nyulangone.org 

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Dana Seag 
Project Coordinator 
NYU Grossman School of Medicine 
One Park Avenue, 7th Floor 
New York, NY 10016 
Phone: 646-754-4917 
Email: Dana.Seag@nyulangone.org 
 
 
2 Introduction, Background Information and Scientific Rationale 
2.1 Background Information and Relevant Literature 
 
This study will observe the impact of the Family Connectors (FC) model on family members who 
participated in OnTrack, a treatment program for adolescents/young adults with symptoms of first episode 
psychosis. The Family Connectors Program is a manualized program that uses a time-limited parent-to 
parent (i.e. peer parent) support and education program delivered by phone to families of youth with 
serious mental health difficulties, assisting family members in becoming fully engaged with provider teams 
who coordinate and provide care. Family Connectors is delivered weekly by phone over the course of 
between three and six months. 
 
This study has potential for significant impact in five ways: (1) it addresses a high-cost, serious, and 
significantly debilitating condition (FEP) with the goal of improving client outcomes; (2) it builds on a major 
national policy initiative and a state-wide priority in NYS; (3) it embeds an intervention tested in prior trials 
into Coordinated Specialty Care (CSC), enhanced with specialized engagement training offered by Co 
Lead Lindsey, a prominent mid-career researcher with expertise in engagement of low-income families of 
color; (4) the model is scalable, as it uses a low-cost, low-intensity enhancement strategy, improving 
potential for broad scaling in other states; and (5) it is nested within publicly-funded mental health (MH) 
sites that disproportionately serve low-income Y/YA. 
 
Family Connectors provides emotional support (i.e., reducing parental stress and social isolation through 
providing emotional support), informational support (i.e., reducing parental stress and social isolation 
through providing emotional support), informational support (e.g., enhancing parental access to resources 
and information), positive attitudes (i.e., helping parents develop positive attitudes toward the importance 
of social support, perceived control, and expected benefits and actions), and caregiver strain. 
 
We are seeking IRB approval to study the impact of Family Connectors upon family member outcomes 
(e.g., self-efficacy, caregiver strain, satisfaction with the program, social supports), and perceptions of 
their relative’s (adolescents/young adults who participated in OnTrack) function and school outcomes. 
 
2.2 Rationale 
 
 
The study seeks to understand the impact of Family Connectors amongst a sample of family members 
who participated in OnTrack with their adolescent/young adult family member. Specifically, we seek to 
examine the impact of FC upon family member outcomes (e.g., self-efficacy, satisfaction with the 
program, engagement in supports), and functional outcomes and service use amongst adolescents/young 
adults. 

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2.3 Potential Risks & Benefits 
2.3.1 Known Potential Risks 
 
There are no physical, social or economic risks associated with participation. The primary risks 
associated with this study is (1) a loss of confidentiality and (2) possible discomfort responding. This risk 
and our actions to protect study participants from the risk are discussed below.  
 
1. To address concerns of breach of confidentiality, all electronic records will be stored on REDCap, 
a HIPAA-compliant electronic data format platform available through NYU Grossman School of 
Medicine. All files and will be kept confidential to the extent permitted by law. Records will only be 
available to research staff, and Federal, State and Institutional regulatory personnel (who may 
view records as part of the routine audits). Privacy will be protected through the use of codes (an 
ID number) rather than with identifying information so that in the unlikely case that materials are 
exposed, the subjects’ identity is not disclosed. REDCap will be used to administer electronic 
questionnaires, with no identifying information appearing on the questionnaires. Participants’ hard 
copy contact forms and ID logs will be kept in a locked cabinet on site. Source documents will be 
shredded in accordance with NYU Grossman Health policy regarding retention of data. All 
electronic data will be kept on password-protected computers. If results are published, only group 
information will be reported and they will not contain any identifying information about any 
individuals.  
 
2. Participants may feel discomfort responding to some of the questions. To mitigate this risk, 
participants will be notified during consenting that they do not have to answer any questions that 
make them uncomfortable.   
 
2.3.2 Known Potential Benefits 
 
The benefits of participation in this study include an opportunity to help to determine the impact of 
Family Connectors as an educational/supportive intervention for family members of individuals with 
first episode psychosis, which in turn is hypothesized to improve adolescent/young adult functioning in 
key domains. 
 
3 Objectives and Purpose 
3.1 Primary Objective 
 
The purpose of this study is to examine the association between involvement in Family Connectors, a 
manualized peer-to-peer support and education program for family members who participated in OnTrack, 
a treatment program for adolescents/young adults with first episode psychosis.  A total of 96 family 
members will be enrolled in this study; of them, 48 will be randomly assigned to Family Connectors + a 
packet of community resources, and 48 will receive the community resource packet alone. Outcomes will 
consist of caregiver self-efficacy, strain, connection to services, satisfaction with the program, and 
functioning of the adolescent/young adult at school and work.   
3.2 Secondary Objectives (if applicable) 
 
N/A 

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4 Study Design and Endpoints 
4.1 Description of Study Design 
 
The study will employ a randomized controlled study design; a total of 96 family members who participated 
in OnTrack with their adolescent/young adult will be randomized to either Family Connectors or a waitlist 
comparison group. Data will be collected at baseline (upon the discharge of the adolescent/young adult 
from OTNY), a follow up (one-month post-baseline) and posttest (seven months post-baseline). For 
participants in the waitlist condition who choose to work with a Family Connector after their posttest, an 
identical posttest will be collected at the end of their 6-month intervention period. Both conditions will receive 
a packet of community resources. 
We will conduct a single qualitative interview with each of the Family Connectors to get feedback on their 
experience as a Family Connector and receive suggestions for further modifications and improvements that 
can be made to the Family Connectors model.  
  
5 Study Enrollment and Withdrawal 
5.1 Inclusion Criteria 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. English speaking or Spanish speaking, 
2. 18 years of age or older, 
3. Family member of adolescents/young adults with first episode psychosis who participated in 
OnTrack.   
 
For the qualitative interviews with our Family Connectors, all individuals working as Family Connectors 
will be eligible to participate.  
 
For the qualitative interviews with family members, all inviduals who worked with a Family Connector, 
either initially or after their time on the waitlist and posttest, will be eligible to participate.  
5.2 Exclusion Criteria 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Does not provide informed consent. 
 
5.3 Vulnerable Subjects 
 
No vulnerable populations will be enrolled.   
5.4 Strategies for Recruitment and Retention 
OnTrack staff inform family members about the study using the recruitment script and recruitment flyer 
which will be distributed as physical flyers and through the OTNY listserv along with study description. If 
interested, secure a document with their contact information and their agreement to be contacted by a 
member of the research team. Potentially eligible participant information will be forwarded to a member of 
the research team, who will provide greater detail about the study, determine eligibility, and answer any 
questions the potential participant may have. If the potential participant meets the eligibility criteria and is 
interested in participating, the research staff will review the consent form with the participant and secure 
informed consent via REDCap. The participant will complete the baseline assessment by phone. 
Retention will be enhanced via gathering multiple phone numbers and having regular contact. Further, to 

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improve enrollment and retention, we will explain to potential subjects that everybody will at some point 
be eligible to get a Family Connector. Participants in the control group will have access to receive a 
Family Connector after the completion of their T3 assessment. 
For the qualitative interviews with our Family Connectors, Family Connectors will be informed about the 
study during their weekly check-in with the research team. If interested in participating, the research staff 
will review the consent form with the Family Connector, titled the “Family Connectors Consent Form,” and 
secure informed consent via REDCap. The participant will complete the interview by zoom.  
For the qualititave interviews with family members, a member of the research team will contact every 
participant who worked with a Family Connector. If interested in participating, the research staff will 
review the consent form with the participant and secure informed consent via REDCap. They will be 
informed that the interview will be used to create a transcript and will choose whether or not they feel 
comfortable having the interview recorded. The participant will also have the choice to complete the 
interview either by Zoom or phone call.  
5.5 Duration of Study Participation 
 
Participants will be enrolled for approximately nine months post-study initiation (baseline to posttest), and 
up to 15 months if they are in the waitlist condition and choose to work with a Family Connector after the 
completion of T3. 
 
The qualitative interview with our Family Connectors will take up to one hour. 
 
The qualitative interview with family members will take up to one hour.  
5.6 Total Number of Participants and Sites  
 
We will aim for a total sample of 96 participants.  
5.7 Participant Withdrawal or Termination 
5.7.1 Reasons for Withdrawal or Termination 
 
Participants are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 
5.7.2 Handling of Participant Withdrawals or Termination 
 
If subjects decline at any time point, they will be considered withdrawn from the study and will no longer 
be contacted for the remainder of the study. 
5.7.3 Premature Termination or Suspension of Study 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 

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by the suspending or terminating party to NYU. If the study is prematurely terminated or suspended, the 
PI will promptly inform the IRB and will provide the reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the sponsor and/or IRB. 
 
6 Study Schedule 
6.1 Enrollment/Baseline 
 
Enrollment/Baseline Visit 1 
• 
Verify eligibility   
• 
Obtain signed informed consent from participants (see the Appendix). 
• 
Collect baseline assessment 
 
Procedures listed are consistent with those included in the Schedule of Events (Appendix A). 
6.2 Intermediate Visits 
Weekly phone calls by a Family Connector for between three and six months. 
 
6.3 Final Study Visit 
Final Study Visit 2 
• 
Complete posttest assessment 
 
Procedures listed are consistent with those included in the Schedule of Events (Appendix A). 
6.4  Withdrawal Visit 
If subject withdraws early or investigator terminates subject participation, the subject will no longer be 
contacted. 
7 Study Procedures/Evaluations 
7.1 Questionnaire Administration 
Study measures include one questionnaire that taps into the following domains: (1) sociodemographic 
characteristics of the family member, (2) family member perceived self-efficacy, (3) family 
member/caregiver social support, caregiver strain, satisfaction with Family Connectors, and (4) the 
adolescent/young adult’s functioning at school and work. The questionnaire will be collected via REDCap 
at three time points (with the exception of the sociodemographic questionnaire, which will be collected at 
T1 only, and satisfaction questions, which will be collected at T3 and T4 only).   

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See the Appendix for a copy of the measures. 
7.2 Procedures/Evaluations 
The measure will be administered at baseline (upon discharge from OTNY), one-month post-baseline 
(prior to intervention) and posttest (following the conclusion of the intervention). For participants in the 
waitlist condition who choose to work with a Family Connector after their posttest, an 
identical posttest will be collected at the end of their 6-month intervention period. 
See the Appendix for a copy of the measure. 
8 Safety and Adverse Events 
8.1 Definitions 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency  (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc) 
• Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 
 
Adverse Event 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• a congenital anomaly or birth defect 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly of major 
clinical significance.   They may jeopardize the subject, and may require intervention to prevent one of the 
other serious outcomes noted above.  For example, drug overdose or abuse, a seizure that did not result 
in in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would 
typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious 
adverse events.  
 

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Preexisting Condition 
A preexisting condition is one that is present at the start of the study.  A preexisting condition should be 
recorded as an adverse event if the frequency, intensity, or the character of the condition worsens during 
the study period. 
 
General Physical Examination Findings 
At screening, any clinically significant abnormality should be recorded as a preexisting condition.  At the 
end of the study, any new clinically significant findings/abnormalities that meet the definition of an 
adverse event must also be recorded and documented as an adverse event.  
 
Post-study Adverse Event 
All unresolved adverse events should be followed by the investigator until the events are resolved, the 
subject is lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the 
investigator should instruct each subject to report any subsequent event(s) that the subject, or the 
subject’s personal physician, believes might reasonably be related to participation in this study.  The 
investigator should notify the study sponsor of any death or adverse event occurring at any time after a 
subject has discontinued or terminated study participation that may reasonably be related to this study.  
The sponsor should also be notified if the investigator should become aware of the development of 
cancer or of a congenital anomaly in a subsequently conceived offspring of a subject that has participated 
in this study.  
 
8.2 Recording of Adverse Events 
At each contact with the subject, the investigator must seek information on adverse events by specific 
questioning and, as appropriate, by examination.  Information on all adverse events should be recorded 
immediately in the source document, and also in the appropriate adverse event module of the case report 
form (CRF).  All clearly related signs, symptoms, and abnormal diagnostic procedures results should 
recorded in the source document, though should be grouped under one diagnosis. 
 
All adverse events occurring during the study period must be recorded.  The clinical course of each event 
should be followed until resolution, stabilization, or until it has been determined that the study treatment or 
participation is not the cause.  Serious adverse events that are still ongoing at the end of the study period 
must be followed up to determine the final outcome.  Any serious adverse event that occurs after the 
study period and is considered to be possibly related to study participation should be recorded and 
reported immediately. 
8.3 Reporting of Serious Adverse Events and Unanticipated Problems 
8.3.1 Investigator reporting: notifying the IRB 
Federal regulations require timely reporting by investigators to their local IRB of unanticipated problems 
posing risks to subjects or others.  The following describes the NYULMC IRB reporting requirements, 
though Investigators at participating sites are responsible for meeting the specific requirements of their 
IRB of record.  
 
Report Promptly, but no later than 5 working days: 
Researchers are required to submit reports of the following problems promptly but no later than 5 working 
days from the time the investigator becomes aware of the event: 
• 
Unanticipated problems including adverse events that are unexpected and related 
– Unexpected: An event is “unexpected” when its specificity and severity are not accurately 
reflected in the protocol-related documents, such as the IRB-approved research protocol, any 
applicable investigator brochure, and the current IRB-approved informed consent document 
and other relevant sources of information, such as product labeling and package inserts.  

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– Related to the research procedures: An event is related to the research procedures if in the 
opinion of the principal investigator or sponsor, the event was more likely than not to be 
caused by the research procedures.  
– Harmful: either caused harm to subjects or others, or placed them at increased risk 
 
Other Reportable events: 
The following events also require prompt reporting to the IRB, though no later than 5 working days: 
• Complaint of a research subject when the complaint indicates unexpected risks or the complaint 
cannot be resolved by the research team. 
• Protocol deviations or violations (includes intentional and accidental/unintentional deviations 
from the IRB approved protocol) for any of the following situations:  
– one or more participants were placed at increased risk of harm  
– the event has the potential to occur again 
– the deviation was necessary to protect a subject from immediate harm 
• Breach of confidentiality 
• Incarceration of a participant when the research was not previously approved under Subpart C 
and the investigator believes it is in the best interest of the subject to remain on the study. 
• New Information indicating a change to the risks or potential benefits of the research, in 
terms of severity or frequency. (e.g. analysis indicates lower-than-expected response rate or a 
more severe or frequent side effect; Other research finds arm of study has no therapeutic value; 
FDA labeling change or withdrawal from market) 
 
Reporting Process 
The reportable events noted above will be reported to the IRB using a Reportable New Information 
submission and will include a description of the event with information regarding its fulfillment of the 
above criteria, follow-up/resolution, and need for revision to consent form and/or other study 
documentation. Copies of each report and documentation of IRB notification and receipt will be kept in the 
Clinical Investigator’s study file. 
9 Study Oversight 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at her site.  This 
safety monitoring will include careful assessment and appropriate reporting of adverse events as noted 
above, as well as the construction and implementation of a site data and safety-monitoring plan. Data 
safety monitoring will occur on an ongoing basis. There will not be any predefined stopping rules for the 
entire study, as it does not pose more than minimal risk for study participants. 
10 Statistical Considerations 
 
10.1 Study Hypotheses 
 
Hypothesis #1: Family members who participate in Family Connectors (i.e., phone-based parent-to-
parent support) will demonstrate improved outcomes at post-test and follow-up as measured by higher 
self-efficacy, greater perceived social support, and lower caregiver strain in comparison to family 
members who receive the comparison condition. 
 
Hypothesis #2: Identified clients whose family members who participate in Family Connectors (i.e., 
phone-based parent-to-parent support) will demonstrate improved outcomes at post-test and follow-up as 
measured by functioning at school and work in comparison to the comparison condition. 

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10.2 Sample Size Determination 
Our sample size was calculated based upon OnTrackNY’s annual enrollment numbers; specifically, there 
are approximately 150 families who graduate each year from Family Connectors; based upon this 
number, we anticipate 96 will participate. 
10.3 Statistical Methods 
 
Univariate statistics will be employed to describe the sample characteristics. Categorical data will be 
presented in percentages; interval and ratio-level data will be presented via measures of central tendency 
and dispersion (e.g., means, standard deviations). Bivariate and multivariate analyses will be conducted in 
order to examine between and within group differences in outcomes. 
11 Source Documents and Access to Source Data/Documents 
 
Source data is all information, original records of clinical findings, observations, or other activities in a 
study necessary for the reconstruction and evaluation of the study.  Source data are contained in source 
documents.  Examples of these original documents, and data records include: hospital records, clinical 
and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy 
dispensing records, recorded data from automated instruments, copies or transcriptions certified after 
verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-
technical departments involved in the study.  
 
The study case report form (CRF) is the primary data collection instrument for the study.  All data 
requested on the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is 
left blank because the procedure was not done or the question was not asked, write “N/D”.  If the item is 
not applicable to the individual case, write “N/A”.  All entries should be printed legibly in black ink.  If any 
entry error has been made, to correct such an error, draw a single straight line through the incorrect entry 
and enter the correct data above it.  All such changes must be initialed and dated.  DO NOT ERASE OR 
WHITE OUT ERRORS.  For clarification of illegible or uncertain entries, print the clarification above the 
item, then initial and date it. 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will 
permit study-related monitoring, audits, and inspections by the IRB/EC, the sponsor, government 
regulatory bodies, and University compliance and quality assurance groups of all study related 
documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities. 
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
 
12 Ethics/Protection of Human Subjects 
12.1 Ethical Standard 
 
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46. 
 
12.2 Institutional Review Board 
 

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The protocol, informed consent documents, recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent document 
must be obtained before any participant is enrolled. Any amendment to the protocol will require review 
and approval by the IRB before the changes are implemented to the study. All changes to the consent 
form will be IRB approved; a determination will be made regarding whether previously consented 
participants need to be re-consented. An IRB reliance agreement will be completed for those sites who 
are not affiliated with NYU. 
 
12.3 Informed Consent Process 
12.3.1 Consent/Assent and Other Informational Documents Provided to Participants 
 
A consent form describing in detail the study intervention, study procedures, and risks are given to the 
participant and documentation of informed consent is required prior to starting intervention. The consent 
form is submitted with this protocol (see the Appendix). 
 
12.3.2 Consent Procedures and Documentation 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Extensive discussion of risks and possible 
benefits of participation will be provided to the participants and their families. Consent forms will be IRB-
approved and the participant will be asked to read and review the document. The investigator will explain 
the research study to the participant and answer any questions that may arise. All participants will receive 
a verbal explanation in terms suited to their comprehension of the purposes, procedures, and potential 
risks of the study and of their rights as research participants. Participants will have the opportunity to 
carefully review the written consent form and ask questions prior to signing. The participants should have 
the opportunity to discuss the study with their surrogates or think about it prior to agreeing to participate. 
The participant will sign the informed consent document prior to any procedures being done specifically 
for the study. The participants may withdraw consent at any time throughout the course of the study. A 
copy of the signed informed consent document will be given to the participants for their records. The 
rights and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
A copy of the signed informed consent document will be stored in REDCap. The consent process, 
including the name of the individual obtaining consent, will be thoroughly documented in the subject’s 
research record. Any alteration to the standard consent process (e.g. use of a translator, consent from a 
legally authorized representative, consent document presented orally, etc.) and the justification for such 
alteration will likewise be documented.  
 
12.4 Participant and Data Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information  
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization. 

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Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to all collected information relating to 
participants. Therefore, the study protocol, documentation, data, and all other information generated will 
be held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, or representatives of the IRB may 
inspect all documents and records required to be maintained by the investigator, including but not limited 
to, medical records (office, clinic, or hospital) and questionnaires for the participants in this study. The 
clinical study site will permit access to such records. 
 
The study participant’s contact information, consent forms, and ID logs will be securely stored for internal 
use during the study in separate locked file cabinets. At the end of the study, all records will continue to 
be kept in a secure location for as long a period as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the Department of Child and Adolescent Psychiatry. This will not include 
the participant’s contact or identifying information. Rather, individual participants and their research data 
will be identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites and by Department of Child and Adolescent Psychiatry research staff will 
be secured and password protected. At the end of the study, all study databases will be de-identified and 
archived at the Department of Child and Adolescent Psychiatry. 
13 Data Handling and Record Keeping 
13.1 Data Collection and Management Responsibilities 
 
Data collection is the responsibility of the study staff at the site under the supervision of the site PI. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of 
data. Black ink is required to ensure clarity of reproduced copies. When making changes or corrections, 
cross out the original entry with a single line, and initial and date the change. 
 
All data will be collected centrally on an ongoing basis by the investigation team electronically on 
REDCap, with no identifying information appearing on the questionnaires. Participants’ name and other 
personal identifying information will be stored in an electronically secure database at NYU 
Langone Medical Center. Privacy will be protected through the use of codes (an ID number) rather than 
with identifying information so that in the unlikely case that materials are exposed, the subjects’ identity 
are not disclosed. All study documents and data will be maintained in password-protected computer files. 
Only the investigation team will have access to the data.  
 
Hard copies of each questionnaire will be kept as records for routine audits. Paper copies of documents 
will be maintained in locked file cabinets. Participant contact forms, consent forms, questionnaires and ID 
logs will be kept in a separate location in a locked cabinet. Source documents will be shredded in 
accordance with NYU Langone Medical Center’s policy regarding retention of data.  
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for 
recording data for each participant enrolled in the study. Data reported in the eCRF derived from source 
documents should be consistent with the source documents or the discrepancies should be explained 
and captured in a progress note and maintained in the participant’s official electronic study record.2 
 

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13.2 Study Records Retention 
 
Study documents will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. These documents should be retained for a longer period, however, if required by 
local regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It 
is the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 
 
13.3 Protocol Deviations 
 
A protocol deviation is any noncompliance with the study protocol or MOP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
 
It is the responsibility of the site to use continuous vigilance to identify and report deviations within 5 
working days of identification of the protocol deviation, or within 5 working days of the scheduled protocol-
required activity. All deviations must be addressed in study source documents. Protocol deviations must 
be reported to the local IRB per their guidelines. The site PI/study staff is responsible for knowing and 
adhering to their IRB requirements. Further details about the handling of protocol deviations will be 
included in the MOP. 
 
13.4 Publication and Data Sharing Policy 
 
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
14 Study Finances 
14.1 Funding Source 
 
This study is financed through a grant from National Institute of Mental Health (NIMH); P50MH113662. 
 
14.2 Costs to the Participant 
 
Subjects will not endure any costs as a result of participating in the study. 
14.3 Participant Reimbursements or Payments 
 
A $50 gift card incentive will be given to participants at each timepoint, for a total of up to $200 per 
participant.     
 
A $50 gift card incentive will also be given to participants upon completion of the qualitative interview, 
meaning each participant could receive up to $250.  

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15 Study Administration 
15.1 Study Leadership 
 
The Study Team will govern the conduct of the study. The Study Team will be composed of the Study 
Chairman, the PI, the study Research Coordinator and Research Assistants. The Study Team will meet 
on a weekly basis. 
 
Dr. Lawrence Palinkas will serve as a consultant in order to assist with the analysis of de-identified 
qualitative data. Dr. Palinkas is a Clinical Professor in the Herbert Wertheim School of Public Health and 
Longevity Science at the University of California, San Diego and an expert in mental health services 
research and implementation science. Dr Palinkas will have no access to PHI or NYULH locations. He 
has no conflicts of interest.  
 
Conflict of Interest Policy 
 
The independence of this study from any actual or perceived influence is critical. Therefore any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this study will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to have such conflicts managed in a way that is appropriate to their participation 
in the study. The study leadership has established policies and procedures for all study group members 
to disclose all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest.  
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Committee with a Committee-sanctioned conflict management plan that has 
been reviewed and approved by the study sponsor prior to participation in this study.  All NYULMC 
investigators will follow the applicable conflict of interest policies. 
 

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16 Attachments 
 
1. Contact form 
2. Consent form 
3. Questionnaire 
4. Farent Connectors manual 
5. Resource Packet 
     

IMPACT Protocol 
 
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Version date: 02.06.2024 
Attachment A 
Schedule of Events 
 
 
 
Activity 
 
Visit 1 (T1) 
 
Visit 2 (T2) 
 
Visit 3 (T3) 
 
Study Team Procedures 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
Assessment 
 
X 
 
X 
 
X