A Pilot Efficacy and Implementation Study of the Patients, Parents and Professionals Partnering to Improve Adolescent Health (P4) Intervention
Phase: NA
Conditions: Adolescent Behavior
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
  
Title: 
A pilot efficacy and implementation study of the Patients, 
Parents and Professionals Partnering to Improve Adolescent 
Health (P4) Intervention 
Short Title: 
P4 
eIRB Number: 
15-011732 
Protocol Date: 
September 16, 2016 
Amendment 1 Date: 9/8/2015 
Amendment 2 Date: 9/28/2015 
Amendment 3 Date: 10/14/2105 
Amendment 4 Date: 11/9/2015 
Amendment 5 Date: 12/22/2015 
Amendment 6 Date: 1/8/2016 
Amendment 7 Date: 2/1/2016 
Amendment 8 Date: 4/11/2016 
Amendment 9 Date: 4/29/2016 
Amendment 10 Date: 5/19/2016 
Amendment 11 Date: 6/3/2016 
Amendment 12 Date: 9/16/2016 
 
Carol Ford, MD 
The Children's Hospital of Philadelphia 
34th & Civic Center Blvd., 11NW10 
Philadelphia, PA 19104 
Phone 215-590-6864 
email: fordc@email.chop.edu 
  
 

 
 
 
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ...............................................................................................................ii 
Abbreviations and Definitions of Terms ..........................................................................iv 
Abstract ..............................................................................................................................v 
Table 1: Schedule of Study Procedures .........................................................................vii 
Figure 1: Study Diagram ....................................................................................................1 
1 
BACKGROUND INFORMATION AND RATIONALE ................................................................ 2 
1.1 
INTRODUCTION ................................................................................................................... 2 
1.2 
RELEVANT LITERATURE AND DATA ........................................................................................ 2 
1.3 
TEEN DRIVING .................................................................................................................... 3 
1.4 
SEXUAL HEALTH ................................................................................................................. 5 
1.5 
ALCOHOL USE / DRINKING ................................................................................................... 6 
1.6 
IMPROVING PARENT-TEEN COMMUNICATION IN PRIMARY CARE ............................................... 6 
1.6.1 
Pilot Data - Acceptability ........................................................................................... 7 
1.7 
COMPLIANCE STATEMENT ............................................................................................................. 7 
2 
STUDY OBJECTIVES .............................................................................................................. 8 
2.1 
PRIMARY OBJECTIVE ........................................................................................................... 8 
2.2 
SECONDARY OBJECTIVES (OR AIM) ....................................................................................... 8 
3 
INVESTIGATIONAL PLAN ...................................................................................................... 9 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................... 9 
3.1.1 
Baseline Screening Phase (T0) ................................................................................. 9 
3.1.2 
Study Intervention Phase (T1) ................................................................................... 9 
3.1.3 
Study Follow-Up Phase ............................................................................................. 9 
3.2 
ALLOCATION TO TREATMENT GROUP .................................................................................. 10 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ...................................................... 10 
3.3.1 
Duration of Study Participation ................................................................................ 10 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected ............................ 10 
3.4 
STUDY POPULATION .......................................................................................................... 10 
3.4.1 
Inclusion Criteria ..................................................................................................... 10 
3.4.2 
Exclusion Criteria .................................................................................................... 11 
4 
STUDY PROCEDURES ......................................................................................................... 12 
4.1 
SCREENING VISIT (T=0) .................................................................................................... 12 
4.2 
STUDY INTERVENTION PHASE ............................................................................................. 12 
4.2.1 
Intervention Materials .............................................................................................. 12 
4.2.2 
Clinic Visit (Intervention subjects only) (T=1) ........................................................... 12 
4.2.3 
Booster Call and T2 Survey (Intervention Parents only) (2 weeks) (T=2) .................. 13 
4.2.4 
Final Follow-Up Survey (approximately 4-6 months) (T=3) ....................................... 14 
4.3 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................. 14 
5 
STUDY EVALUATIONS AND MEASUREMENTS .................................................................. 15 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ........................................ 15 
5.1.1 
Confirmation of eligibility ......................................................................................... 15 
5.1.2 
Contact Information ................................................................................................. 16 
5.1.3 
Baseline Screening Intake Assessment (T0) ............................................................ 16 
5.1.4 
Health Coach Acceptability, Feasibility, and Fidelity Assessment ............................. 17 
5.2 
EFFICACY EVALUATIONS .................................................................................................... 17 
5.2.1 
2 Week Survey [2 weeks post clinic visit (-3 days/+ 2 weeks)] (T2) .......................... 17 
5.2.2 
Final Follow-Up Survey [4-6 months post clinic visit/health coach phone call] (T3) ... 18 
5.3 
SAFETY EVALUATION ......................................................................................................... 19 

 
 
 
 
 
 
 
 
 
 
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6 
STATISTICAL CONSIDERATIONS ....................................................................................... 20 
6.1 
PRIMARY ENDPOINT .......................................................................................................... 20 
6.2 
SECONDARY ENDPOINTS ................................................................................................... 20 
6.3 
STATISTICAL METHODS ..................................................................................................... 20 
6.3.1 
Baseline Data.......................................................................................................... 20 
6.3.2 
Efficacy Analysis ..................................................................................................... 20 
6.3.3 
Safety Analysis ....................................................................................................... 21 
6.4 
SAMPLE SIZE AND POWER ................................................................................................. 21 
7 
PATIENTS, PARENTS AND PROVIDERS PARTNERING TO PROMOTE ADOLESCENT 
HEALTH (P4) INTERVENTION ...................................................................................................... 23 
7.1 
DESCRIPTION ................................................................................................................... 23 
7.1.1 
Trained RA Health Coaches (HC) ............................................................................ 23 
7.1.2 
Intervention Materials .............................................................................................. 23 
7.1.3 
Endorsement by Health Care Provider .................................................................... 23 
7.2 
CLINICAL ADVERSE EVENTS ............................................................................................... 24 
7.3 
ADVERSE EVENT REPORTING ............................................................................................. 24 
8 
STUDY ADMINISTRATION.................................................................................................... 25 
8.1 
TREATMENT ASSIGNMENT METHODS................................................................................... 25 
8.1.1 
Randomization ........................................................................................................ 25 
8.2 
DATA COLLECTION AND MANAGEMENT ................................................................................ 25 
8.3 
CONFIDENTIALITY .............................................................................................................. 25 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS ..................................................................... 25 
8.4.1 
Data and Safety Monitoring Plan ............................................................................. 25 
8.4.2 
Risk Assessment..................................................................................................... 26 
8.4.3 
Potential Benefits of Trial Participation .................................................................... 26 
8.4.4 
Risk-Benefit Assessment......................................................................................... 26 
8.5 
RECRUITMENT STRATEGY .................................................................................................. 26 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ................................................... 26 
8.6.1 
Waiver of Documentation of Consent and Partial Waiver of HIPAA .......................... 27 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................... 27 
9 
PUBLICATION ....................................................................................................................... 28 
10 REFERENCES ....................................................................................................................... 29 
Appendix ..........................................................................................................................31 
 

 
 
 
 
 
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
 
Adverse event 
P4 
 
Patients, Parents, and Professionals Partnering to 
Improve Adolescent Health  
TDP 
 
TeenDrivingPlan 
ALC 
 
Alcohol  
HCP 
 
Health care provider (physician, MD, nurse practitioner, 
NP) 
PeRC 
 
Pediatric Research Consortium 
HC 
 
Health Coach 
RA 
 
Research Assistant 
F/U 
 
Follow-Up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
v
ABSTRACT 
Context:  Primary care provides a means by which to connect evidence-based interventions 
with patients; however, many interventions have been evaluated using RCTs in non-
healthcare settings.  Three adolescent health domains are well-suited to explore delivery of 
evidence-based interventions in the context of primary care: teen driving, sexual health, and 
alcohol use. In each of these three areas effective parent-directed interventions have been 
identified that measurably impact adolescent health and safety (Turrisi, Jaccard, Taki, et al., 
2001; Guillamo-Ramos, Bouris, Jaccard, et al., 2011; Mirman JH, Curry AE, Winston FK, et 
al., 2014).  
Objectives:  
The primary objective is to conduct a pilot study to determine the effectiveness of evidence-
based interventions delivered in primary care clinic settings on adolescent health behaviors 
and health outcomes.  Key secondary objectives include assessing intervention 
implementation fidelity in clinical settings and examining the effect of interventions on 
parent-teen communication. 
Study Design:  
Randomized controlled trial with 2 study arms and 5 possible randomization groups [Arm 1 
(14-15 year olds at well-child visit): Sexual Health, Alcohol, Control; Arm 2 (16-17 year olds 
at well-child visit): Driving, Control]. See Figure 1. 
Setting/Participants: 
The study will take place in primary care practices in the CHOP Network.  Eligible 
participants are CHOP primary care patients that will be 14-17 years of age at their 
upcoming well-child visit OR 16-17 year olds that dropped off their medical certification 
forms for their permit application to be signed by their primary care provider. They must 
have a scheduled well-child visit and a willing parent participant that is planning to attend 
their appointment with them OR have dropped off their medical certification form in the past 
8 weeks. Adolescents that are attending a new patient well-child visit, hold an intermediate 
driver’s license, that are pregnant, or that have pervasive development disorder or a 
developmental delay are excluded from this study. Parents and adolescents must be fluent 
in written and spoken English as the intervention materials and health coaching is only 
available in English. Additionally, health care providers and research assistants (health 
coaches) implementing the intervention will be participants in the research study.  
Study Interventions and Measures:  
The study intervention being examined is called Patients, Parents, and Professionals 
Partnering to Improve Adolescent Health (P4) and includes written materials on adolescent 
health topics (parent-teen communication, sexual health, alcohol, driving – inclusive of The 
TeenDrivingPlan Parent Guide), activity workbooks, tip sheet brochures, in person/phone 
health coaching, and in person or mailed health care provider endorsement and key 
messaging.   Measures will be collected at baseline pre-intervention (T0), in clinic or over 
the phone at the time of the intervention (T1), two weeks post- intervention (T2), and 4 to 6 
months post-intervention (T3) (See Table 1). We will measure feasibility of clinic 
implementation of interventions, as well as influence of interventions on parent-teen 

 
 
 
 
 
 
 
 
 
 
vi
communication, parent and teen knowledge, parent and teen cognitions, and adolescent 
behavioral intentions and behavior. At the conclusion of recruitment, health care providers 
will be asked to complete a Health Care Provider Feedback Survey. 

 
vii  
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES 
Study Phase 
Baseline 
Screening 
Intervention 
Phone Call/ 
Clinic Visit 
 
Intervention  
Booster Call 
and Survey 
Final 
Follow-up 
Survey 
Final Provider 
Feedback Survey  
Visit Number 
T=0 
T=1 
T=2 
T=3  
N/A 
Study Days 
 
0 
2 weeks 
4-5 months (Arm 1); 
6 months (Arm 2) 
 
Study Letter to Families 
X 
 
 
 
 
Verbal Consent to Screen 
X 
 
 
 
 
Informed Consent/Assent 
X 
 
 
 
 
Demographic/Intake survey 
X 
 
 
 
 
Randomization  
X 
 
 
 
 
Distribute Intervention 
Materials  
X 
X 
 
X 
 
Clinic Orientation Session 
 
X 
 
 
 
HCP Endorsement 
 
X 
 
 
 
Booster Call and Survey 
 
 
X 
 
 
Final Follow-Up Survey 
 
 
 
X 
 
Adverse Event Assessment 
 
X 
X 
X 
 
Quality Improvement 
Survey with HCPs 
 
 
 
 
X 
 
 

 
  
 
 
 
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FIGURE 1: STUDY DIAGRAM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*P = Parent; T = Teen 
Population: CHOP Primary Care Patients  
Arm 1  
(14 – 15 yrs) 
Randomize 
Arm 2 
(16 – 17 yrs) 
Randomize 
Usual 
Practice 
Teen 
Driving 
Booster 
Call & Survey 
(P) 
Usual 
Practice 
Sexual 
Health 
Alcohol 
Prevention 
Screen 
Screen 
Out 
Clinic 
Intervention 
(P + T) 
Final F/U 
Survey 
(P + T) 
 
Intake Survey  
(P + T) 
Intake 
Survey  
(P + T) 
 
Intake Survey  
(P + T) 
Intake 
Survey  
(P + T) 
Final F/U 
Survey 
(P + T) 
Final F/U 
Survey 
(P + T) 
Final F/U 
Survey 
(P + T) 
Clinic or Phone 
Intervention 
(P + T) 
Booster 
Call & Survey 
(P) 

 
  
 
 
 
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1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 
Introduction 
Prior research has found that relationships between health care professionals (HCP)’s, 
parents and adolescent patients can be enhanced directly and indirectly (Ford et al., 2011). 
Direct strategies involve strengthening relationships and/or communication between 
parents and HCPs in both practice and community settings. Indirect strategies involve 
opportunities for HCPs to influence parent–adolescent relationships and/or communication 
within the context of adolescent visits. For example, HCPs can discuss the importance of 
parental involvement and monitoring with adolescents, encourage and facilitate parent–
adolescent communication, and deliver tailored parental guidance (Ford et al., 2011).  
Primary care practices provide a means by which to connect evidence-based interventions 
with patients and parents; however, many interventions have been evaluated using RCTs in 
non-healthcare settings. Implementing (and/or disseminating) and studying these 
interventions in health care settings, such as primary care, will require additional research 
concerning implementation fidelity and efficacy.  
1.2 
Relevant Literature and Data 
An evidence-informed conceptual model for intervening with HCPs and parents is 
presented in Figure 2. As depicted in this figure, HCPs can provide general and 
individualized (i.e., tailored information) to parents in order to improve adolescent health. 
More specifically, HCPs can endorse evidence-based interventions and provide a pathway 
to obtain evidence-based interventions for parents and teenagers. Coupled with the 
endorsement of the HCPs, parent-directed interventions to improve adolescent health might 
gain potency. As depicted in Figure 2, armed with their new knowledge and skills, parents 
can alter the content and nature of their communications with their adolescent, provide 
novel resources and domain-specific support, and continue to monitor with warmth, and 
encourage autonomy to promote overall health and safety. 
Many adolescent health domains are well-suited to explore delivery of evidence-based 
interventions in the context of primary care. In the current study we will examine three topic 
areas: teen driving, sexual health, and alcohol use. In each of these three areas effective 
parent-directed interventions have been identified that measurably impact adolescent 
health and safety (Turrisi, Jaccard, Taki, et al., 2001; Guillamo-Ramos, Bouris, Jaccard, et 
al., 2011; Mirman JH, Curry AE, Winston FK, et al., 2014). Pathways for delivery of these 
interventions in health care settings that ensures implementation fidelity are lacking.  
Additionally, these interventions do not contain administrative content directed specifically 
to HCPs. Developing and evaluating this new content for implementation and efficacy will 
be critical for effective deployment.  

 
  
 
 
 
3 
 
1.3 
Teen Driving 
Motor vehicle crashes remain the leading cause of death among teens in the United States. 
Teen drivers (ages 16 to 19) are in fatal crashes at four times the rate of adult drivers (ages 
25 to 69). Inexperience is a fundamental factor in the high crash rate for novice teens. 
Studies have shown that novice drivers are at highest risk for crashing within the first six 
months post-licensure; by contrast, the lowest lifetime risk of crashing occurs when the teen 
is driving while accompanied by an adult as a “learner driver” (Mayhew, Simpson, & Pak, 
2003; McCartt, Shabanova, & Leaf, 2003). During the learner period, teens ride with both 
family members and instructors. Many but not all teens learn driving skills through a 
minimal amount (on average, six hours) of behind-the-wheel lessons with instructors. 
Nearly all teens learn to drive with adult family members (usually parents). The learner 
period provides an opportunity to teach, practice and evaluate whether the teen has the 
behaviors and skills necessary to ride without adult supervisions. Unfortunately, the 
quantity, quality and diversity of practice driving is very limited and many teens start 
unsupervised, post-licensure driving without sufficient preparation. 
Safe and skilled driving is a complex task that involves behaviors (e.g., skills and actions) 
that may vary by driving environment. Scanning, for example, is such a behavior. On 
neighborhood roads, the driver needs to learn how to scan for other road users (e.g., 
bicyclists) or unexpected hazards (e.g., a child darting out in the street). In contrast, 
highway driving requires the driver to learn how to scan far ahead in order to detect 
changes in driving conditions in sufficient time to slow or stop from a high speed. These 
behaviors are learned through instruction and a considerable amount of experience. Ideally, 
the behaviors are first taught by a professional (e.g., a driving instructor) while families 
provide the necessary hours of practice. Varied, high quality practice driving with an adult 
family member for a sufficient number of hours can provide teens with a safe way to gain 
needed experience that will prepare him/her to ride safely without supervision once 
licensed. 
The TeenDrivingPlan.org (TDP) has been designed to help improve the quantity and quality 
of parent facilitated-practice driving through guided learning, planning and logging of 
practice drives. More specifically, the program encourages parents to increase the number 
Figure 2. General framework for parent-HCP partnerships to improve adolescent health  

 
  
 
 
 
4 
of hours of behind-the-wheel (BTW) practice and to increase the range of environmental 
conditions and driving behaviors explicitly practiced during those hours. The program 
provides targeted on-line education and tools for planning and logging. All choices and 
plans for practice driving activities are made by the families.  
 
The program integrates practical information for parents and teens with evidence-based 
intervention components to promote practice driving. It includes text-based information; 
videos, graphical and audio materials; and interactive planning and logging tools. TDP is a 
tool to provide families with a structure for facilitating practice drives by grouping road types 
into progressively complex environments in which teens will practice specific driving 
behaviors and skills. It presents information organized around driving environments, which 
include a large empty parking lot, residential neighborhoods, commercial roads, 
intermediate and rural roads and highways, as well as challenging driving situations such 
as driving at night and in inclement weather. 
 
Content was identified using a variety of research methods including literature review, 
parent and teen focus groups, a 2010 process evaluation study (IRB 10-007530) of an 
early, limited version of TDP, interviews with international scientific driving experts, and 
interviews with a panel of expert driver education instructors. Creative content was 
developed and refined using input from parents, teens, and driver education instructors. 
Usability testing informed the design and functionality of the web application. Results from a 
randomized controlled trial are shown in Table 2 (IRB 11-008203) (Mirman, Curry, Winston, 
et al., 2014; Mirman, Albert, Curry, et al., in press; Winston, Mirman, Curry et al., 2014). 
Stemming from this success, a novel implementation of  an adapted version of TDP in the 
primary care setting in conjunction with providers’ completion of the state of Pennsylvania’s 
driver’s license permit form (DL-180 (3-14)) could offer several advantages. This form 
requires qualified health care providers to affirm that there are no medical or psychiatric 
conditions (e.g., uncontrolled diabetes, alcohol or drug abuse, other cognitive impairment) 
that preclude the teenager from safely pursuing licensure. Completion of this form could be 
Table 2.  Key Results of the TDP Evaluation (Randomized Controlled Trial)  
(1) Driving Skill: Teenagers in the TDP group were 65% less likely to fail a rigorous on-
road driving assessment. The Hazard Ratio for exposure to TDP was 0.35 (95% CI, 
0.12-1.03; log-rank p = 0.05). Six percent of teenagers that used TDP had their on-
road driving assessment terminated due to unsafe driving performance as compared 
to 15 percent of those not given TDP (risk difference [TDP-control]: -9% (-21%, 2%), 
p = 0.06).  
(2) Parent Supervision: TDP parents were more engaged supervisors (e.g., regularly 
logged drives, gave feedback) (parent and teen report), p = 0.03 and TDP teens 
reported greater instrumental and socioemotional support from parents related to 
practice driving (teen report), p = 0.01. 
(3) Practice Variety: TDP dyads practiced at least 1-2 hours in a greater variety of 
driving environments than control dyads, p = 0.01 (parent and teen report). This 
increase in variety mediated the effect of TDP on driver performance. 
(4) TDP Use: The estimated relative rate (RR) of TDP use (valid log-ins) was three times 
higher (3.08, 95% CI 1.67 to 5.69) during the first week among dyads who achieved 
high practice diversity compared to dyads who practiced in fewer environments. At 
week 3, the RR was 1.55 times higher (95% CI 0.99 to 2.43); use was similar by week 
5. 

 
  
 
 
 
5 
leveraged to support the provision of evidence-based tools and interventions for all families. 
However, there are no best-practice guidelines that support completion of this form, which 
is supposed to be signed by the applicant in the presence of the provider and no 
interventions directly connected to supporting this critical provider-patient-parent interaction 
at the outset of adolescent patients entering their highest lifetime risk for a MVC.  
1.4 
Sexual Health 
According to the Youth Risk Behavior Surveillance (CDC, 2013) 46.8% high school 
students reported previously having sexual intercourse and 34.0% had intercourse in the 
previous 3 months (i.e., were “currently” sexually active). Nearly 41% of students who had 
sex in the prior 3 months did not use a condom the last time they had sex, 15.0% had at 
least four or more sexual partners, 19% reported that they (or their partner) used birth 
control pills to prevent pregnancy at the time of last sexual intercourse, while 14% reported 
using no form of birth control.   Further, almost 23% had used drugs or alcohol before their 
last time of sexual intercourse. Collectively, these behaviors increase adolescents’ risk for 
sexually transmitted infections (STIs) and unintended pregnancy (CDC, 2009; Weinstock, 
Berman & Cates, 2004; Hamilton, Martin & Ventura, 2009). Delaying the time of first sexual 
intercourse and promoting safe sexual practices including using birth control and regular 
STI testing among sexually active youth is paramount for preventing STIs and unintended 
pregnancies.  
A variety of methodologies have been employed to encourage adolescents to adopt safe 
and responsible sexual practices to youth of varying levels of risk. Parent-directed 
approaches offer several unique benefits compared to group-based or school-delivered 
programs including the opportunity for parents to communicate information consistent with 
their personal values, tailor information to be responsive to the child’s life circumstances 
and contexts and their child’s developmental level (e.g., cognitive, social and emotional), 
and bundle these communications into a broader set of parent-child interactions related to 
monitoring and surveillance (Jaccard, Dodge, Dittus, 2002).   
A clinic-based RCT (n=264 dyads) was conducted to evaluate the efficacy of Families 
Talking Together, a parent-based intervention to prevent sexual risk behavior, among 
Latino and African American male and female teenagers between the ages of 11 to 14 
years and their mothers, compared to a standard care control condition (Guillamo-Ramos, 
Bouris, Jaccard et al., 2011). Intervention components were delivered to mothers in waiting 
rooms during their teenagers’ clinic visits. Dyads completed a brief baseline survey in the 
clinic, were randomized and then completed a follow-up survey nine months later in the 
home. Primary outcomes included whether the adolescent had ever engaged in vaginal 
sexual intercourse (yes or no), and among the sexually active respondents, the frequency 
of sexual intercourse, and the frequency of oral sex were ascertained. The parent-directed 
intervention consisted of 4 key components: (1) a 30 minute face-to-face meeting with a 
social worker; (2) a written informational “manual” on effective communication and 
parenting strategies for reducing adolescent sexual risk behavior with two activity guides; 
(3) booster phone calls to direct parents to the intervention materials and 4) provider 
endorsement of the materials.  Findings from the RCT found that sexual activity was 
attenuated in the intervention group (6%) and increased from 6% to 22% for young adults in 
the control condition. Incorporating this effective intervention into the workflow of a busy 
primary practice requires considering how to repackage successful intervention 
components and materials in a cost-effective and scalable way.  

 
  
 
 
 
6 
1.5 
Alcohol Use / Drinking 
According to the Youth Risk Behavior Surveillance (CDC, 2013), 66.2% of high school 
students nationwide had at least one drink of alcohol on at least 1 day during their life and 
34.9% of high school students had drunk alcohol in the previous 30 days.  21.9% of 
students nationwide had ridden in a car driven by someone who had been drinking alcohol 
and 10.0% (of the 64.3% of youth who drove in the last 30 days) had driven when they had 
been drinking alcohol.  Nationwide, 20.8% of students had had five or more drinks of 
alcohol in a row.  
Data from the National Longitudinal Study of Adolescent Health indicates that problem 
drinking occurs in youth as early as seventh grade and that young people are more likely to 
exhibit binge drinking behaviors if they report poor parental communication and monitoring 
(Guilamo-Ramos, Jaccard, Turrisi et al., 2005).  Thus, one potential strategy for dealing 
with alcohol problems in youth is by improving parental communication about and 
monitoring of alcohol related behaviors.  A particularly promising parent-based intervention 
attempted to influence students before they start college through their parents (Turrisi, 
Jaccard, Taki, et al., 2001). Specifically, parents received informational materials about the 
prevalence and risks associated with binge drinking and how to convey information about 
drinking to their teens.  Parents were encouraged to talk with their teens prior to leaving for 
college.  Teens whose parents implemented the intervention materials exhibited reduced 
drinking tendencies and experienced fewer drinking-related consequences. 
 
1.6 
Improving Parent-Teen Communication in Primary Care 
Research shows that parents play an important role in their child’s health.  In particular, 
parent-based interventions that seek to improve parent-teen communication have been 
shown to be effective at reducing adolescent risk taking and improving adolescent healthy 
decision making.  According to Jaccard, Dodge and Dittus (2002) parent-based approaches 
allow parents to: (1) discuss information in a way that is consistent with their values, (2) 
alter the presentation of information to fit social and familial contexts, and (3) increase 
supervision of teenagers’ activities. Additionally, previous studies have shown parent-teen 
communication to be an important factor in reducing adolescent risk taking behaviors. One 
clinic-based RCT that evaluated a parent-based intervention to reduce sexual risk behavior 
in early adolescence found that sexual activity remained at 6% among adolescents in the 
intervention condition, but increased from 6% to 22% for adolescents in the “standard of 
care” control condition (Guillamo-Ramos, Bouris, Jaccard et al., 2011). Similarly, a parent-
based intervention designed to influence college drinking behaviors was shown to reduce 
drinking and tendencies toward drunkenness, increase negative perceptions toward 
drinking activities, reduce peer and parental approval of drinking, and decrease drinking-
related consequences (Turrisi, Jaccard, Taki, et al., 2001). Additionally, parents identified 
parent-teen communication as an important factor in keeping teens healthy in a small, 
exploratory study examining the partnership between parents and health care providers. 
Parents were asked: What can parents do to keep teens healthy and address health 
problems? 47% of parents mentioned parent-teen communication, citing the importance of 
talking, listening and giving encouragement (Ford, Davenport, Meier et al., 2009). Our own 
pilot work confirmed that parents are interested in getting information from their child’s 
primary health care provider about how to communicate with their child about a range of 
health behaviors (Ford et al., manuscript in preparation).  Primary care is an ideal location 
to intervene on parent-teen communication as it is protected time for discussing important 
teen health issues and it involves a trusted expert, who can highlight the importance of 

 
  
 
 
 
7 
parent-teen communication about teen health issues and endorse evidence-based 
interventions for parents to continue discussions at home.   
1.6.1 Pilot Data - Acceptability 
During qualitative pilot work (IRB # 14-010850), we investigated adolescent and parent 
interest in receiving information about health topics and parent-teen communication from 
clinicians (Ford et al., manuscript in preparation). 91 parent-adolescent dyads completed 
individual interviews assessing their levels of interest in receiving health and health 
communication information from the adolescent’s doctor about a variety of topics, including 
routine, mental health, sexual health, substance use, and injury prevention issues.  The 
sample consisted of mostly female parents (84%) and adolescents that were evenly divided 
by gender and age; 36 were 12-13, 35 were 14-15, and 20 were 16-17 years of age. 
Adolescent race reflected the practice population (60% black; 35% white). Results indicated 
that the majority of parents and adolescents reported moderate or high levels of interest in 
receiving information about all health issues, inclusive of information to increase parent-
teen communication.  From this preliminary work, it is clear that both parents and 
adolescents want health care professionals to help them learn, and talk about, a wide range 
of adolescent health topics. Thus, primary care interventions that effectively improve 
parent-teen health communication and specific adolescent health outcomes would be of 
value to parent and teens.  
 
Additional pilot work was conducted to determine acceptability of the intervention materials 
prior to trialing them (IRB #15-011780). We recruited 68 parents of adolescent CHOP 
PBRN patients to review and provide feedback on intervention materials (parent-teen 
communication, targeted health topics) and study procedures. The study sample primarily 
consisted of caregivers who were mothers (90%), had a 4-year degree or more (64%), were 
married (65%) and had an average of 2 children. About half (54%) of the caregivers were 
African American followed by white (43%); few caregivers were Hispanic (2%). 92% 
regularly wear a seatbelt when they drive a vehicle and 78% regularly use the internet or 
check email several times a day from home.  In general, participants liked the materials and 
cited several benefits including: “opening the door to having a dialogue with your teen”, 
“getting on the same page as their teen’s doctor”, and “sending a consistent message to the 
teen.”  Parents reported a strong likelihood that they would use the materials and 
expressed a strong desire to participate in a related research study (unpublished results; 
contact Jessica Mirman for more details). 
1.7 
Compliance Statement 
This study will be conducted in full accordance with all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures. All episodes of noncompliance will be 
documented. 
The investigators will perform the study in accordance with this protocol, will obtain consent 
and assent, and will report unanticipated problems involving risks to subjects or others in 
accordance with The Children’s Hospital of Philadelphia IRB Policies and Procedures and 
all federal requirements. Collection, recording, and reporting of data will be accurate and 
will ensure the privacy, health, and welfare of research subjects during and after the study.  

 
  
 
 
 
8 
2 
STUDY OBJECTIVES 
The purpose of the pilot study is to determine implementation fidelity and efficacy of parent-
based interventions conducted in a primary care practice. 
2.1 
Primary Objective   
The primary objective of the study is to determine if the intervention(s) affect teen health 
behaviors and cognitions. 
2.2 
Secondary Objectives (or Aim) 
The secondary objectives are to: (1) assess the impact of the interventions on the quality of 
parent-teen communication and their knowledge about important teen health behaviors; (2) 
assess the fidelity of implementation of the interventions in clinic settings; and (3) to 
conduct exploratory analyses to refine the theoretical model on which the interventions are 
based. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  
 
 
 
9 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
This is a pilot randomized controlled trial to assess efficacy, estimate clinic-level effect sizes 
on key outcomes, and assess the implementation of the P4 intervention. See Figure 1 and 
Table 1 for overviews. 
3.1.1 Baseline Screening Phase (T0) 
Potential subjects will be identified using EPIC as all will come from participating PeRC 
primary care practices. Additionally, 16-17 year old patients will be identified by the 
participating primary care practice when patients drop off their medical certification form for 
the permit application to be signed by their CHOP primary care provider.  A letter will be 
given or sent in the mail to all eligible families to describe the study and give them the 
opportunity to call or email the study team for more information about participating. They 
will be verbally screened and consented using the protocol inclusion and exclusion criteria 
into two strata based on age at upcoming well-child visit (Arm 1: 14 to 15 years and Arm 2: 
16 to 17 years) OR current age (16-17) if teen recently had medical certification form 
signed. We are requesting a waiver of assent for screening procedures, however parental 
consent and child assent will be obtained over the phone for the main study procedures. 
We are also requesting a waiver of written documentation (see Section 8.6.1). After 
randomization into a study group, a demographic and baseline intake survey will be 
completed with the parent and teen over the phone and the educational materials will be 
sent electronically (Arm 2 only), mailed (Arm 2 only), and/or given in person to the 
intervention group parents after enrollment. For a full list of assessment instruments see 
section 5.0. 
3.1.2 Study Intervention Phase (T1) 
The study intervention involves educational materials for parents to read, an in person or 
phone orientation to the intervention materials delivered by a trained Research Assistant 
(RA), as well as a brief endorsement of the materials by the health care provider (HCP) 
during the teen’s well-child care appointment or via a provider “prescription” mailed to the 
parent, and a booster health coach call delivered by a trained RA. The RA will complete a 
fidelity assessment after the health coaching clinic visit or phone call, and booster call to 
document the components of the intervention that were delivered.   
3.1.3 Study Follow-Up Phase 
3.1.3.1 T2 
A survey will be administered to parents in the intervention groups via phone or a secure 
web survey platform within 2 weeks (- 3 days/ + 2 weeks) of the health coaching clinic visit 
or health coaching phone call.  Surveys can be conducted at the end of the booster call or 
will be scheduled for another date depending on parent availability. For a full list of 
assessment instruments see section 5.0. 
3.1.3.2 T3 
Electronic and/or phone follow-up surveys will be collected with all parents and teens in 
Arm 1 approximately 4-5 months after the well-child appointment and with all parents and 
teens in Arm 2 approximately 6 months after the well-child appointment or health coach 
phone call.  For a full list of assessment instruments see section 5.0. 

 
  
 
 
 
10
3.2 
Allocation to Treatment Group 
Randomization will be performed using a table of random numbers generated at the outset 
of the study. Neither the RA enrolling the dyad or the parent/teen dyad who agrees to 
participate will be blind to the dyads’ allocations.  During screening, participants will be 
allocated into two strata based on age at upcoming well-child visit (Arm 1: 14 to 15 years 
and Arm 2: 16 to 17 years) (See Figure 1). 16-17 years old who drop of their medical 
certification forms for the permit application will automatically be allocated into Arm 2. 
Participants in Arm 1 will be randomly assigned to receive usual care (control), the alcohol 
intervention, or the sexual health intervention.  Participants in Arm 2 will be randomly 
assigned to receive either usual care (control) or the teen driving intervention.  
3.3 
Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
Arm 1 – Approximately 4-5 months from the time of enrollment. 
Arm 2 - Approximately 6-7 months from the time of enrollment. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted within participating clinical sites in the CHOP PeRC network. 
Approximately 900 total subjects will be enrolled to produce 375 evaluable subject dyads 
(375 adolescents and 375 parents). Additionally, approximately 15 health care providers will 
be enrolled to produce 10 evaluable health care provider subjects.  Finally, approximately 
10 research assistants (health coaches) will be enrolled to produce 5 evaluable subjects. 
3.4 
Study Population 
3.4.1 Inclusion Criteria 
Adolescents 
1) Males or females age 14 to 17 years at the time of their upcoming well-child visit OR  
at the time their medical certification form for the permit application is completed. 
2) CHOP primary care patient. 
3) Scheduled for a well-child visit that parent and teen both plan to attend OR had their 
medical certification completed in the past 8 weeks by a health care provider at a 
CHOP Primary Care Practice 
4) [For Arm 2 only] Planning on having the medical certification for the permit 
application completed at their next well child visit OR had their medical certification 
completed in the past 8 weeks by a health care provider at a CHOP Primary Care 
Practice and planning on taking their driving permit test in the next 8 weeks.  
Parents 
1) Parent or legal guardian of a male or female age 14 to 17 years at their upcoming 
well-child visit at a CHOP primary care practice or at the time the teen’s medical 
certification form for the permit application was completed. 
 
Health Care Providers 

 
  
 
 
 
11
 
1) Health care provider employed at a CHOP PBRN primary care site participating in 
the study (IRB 15-011732) 
 
Research Assistant / Health Coach 
 
1) Research staff member listed on the protocol (IRB 15-011732) 
 
2) Trained by PI to participate in health coach activities 
 
3.4.2 Exclusion Criteria 
Adolescents 
1) Not fluent in written or spoken English. 
2) Attending a new patient well-child visit. 
3) Developmental Delay or Pervasive Developmental Disorder. 
4) Pregnant female. 
5) Already has driving permit (has taken and passed the knowledge test). 
Parents 
1) Not fluent in written or spoken English. 
Health Care Providers 
 
None 
 
Research Assistant / Health Coach 
 
None 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of 
these criteria must be reported in accordance with IRB Policies and Procedures.  
It is possible that more than one eligible teen from a given family will be eligible to enroll, as 
families often schedule appointments back to back.  In these instances, only one parent-
teen dyad per household will be enrolled.  The decision on who to enroll will be selected 
based on the following criteria: 1) If there is an adolescent aged 16-17 that is eligible for 
Arm 2, we will prioritize recruitment of this dyad; 2) If we are unable to recruit this dyad, 
then we will randomly select from the remaining eligible adolescents.   
 
 
 

 
  
 
 
 
12
 
 
 
4 
STUDY PROCEDURES 
4.1 
Screening Visit (T=0) 
The study screening phase involves a letter being given or mailed home to describe the 
study to all eligible participants, verbal consent to screen (waiver of assent is requested), 
verbal informed consent and assent over the phone.  After participants are enrolled, they 
will be randomized into a study group. Then we will administer a brief baseline intake 
survey to parents and teens separately over the phone and/or we will send it electronically 
to collect sociodemographic information, baseline parenting and parent-teen 
communication and relationship variables, baseline cognition variables, and baseline 
assessment of health behavioral variables.   
The following procedures will take place during the phone screening visit: 
 
Verbal Consent to Screen (Waiver of Assent Requested) 
 
Informed Consent and Assent 
 
Randomization 
 
Administration of Baseline Screening Intake Assessment with parent and teen  
 
Email electronic versions of the intervention materials to intervention group parents 
(Arm 2 only) 
 
4.2 
Study Intervention Phase 
The study intervention phase consists of written materials for parental review, an RA 
orientation at the child’s well-child visit or over the phone, a physician endorsement given 
during the child’s well-child clinic appointment or mailed to the home, and a booster phone 
call from the RA approximately 2 weeks after the initial orientation of the intervention 
materials.  
4.2.1 Intervention Materials  
Intervention materials are shown in Appendix A-D.  Arm 1 participants in the intervention 
groups will receive a parenting handbook (Appendix A) that focuses on how to 
communicate effectively and respectfully with teenagers. It contains written information and 
activities. Depending on which group the patient is randomized to, parents will also receive 
an additional module and tip sheet on one of three health behaviors: (1) sexual health 
(Appendix B); (2) alcohol prevention (Appendix C); and (3) teen driving (Appendix D). 
Materials will be sent electronically to intervention group parents (Arm 2 only) after 
enrollment and will be provided in hardcopy to intervention group parents at the teen’s well-
child appointment if applicable.  Parents in the control group will be emailed or mailed 
intervention materials at the end of the study when all surveys are complete. 
4.2.2 Clinic Visit (Intervention subjects only) (T=1) 
Intervention group parents will be greeted at the clinic prior to their child’s well-child 
appointment by a member of the research team. In a private location the parent will receive 

 
  
 
 
 
13
a brief orientation to the materials by a trained RA health coach on the topic to which 
they’ve been assigned. This discussion will typically happen while the teen is having their 
well-child visit. At the end of the well-child examination the parent and teen will meet briefly 
with the HCP who will endorse the materials and provide key health and safety messages 
using a brief Provider Endorsement Sheet (see Appendix E). The parent will leave the 
appointment/visit with an agreed-upon date scheduled to talk to the teen about the health 
topic (driving, sexual health, alcohol) and with a “prescription” for reading/using the 
materials and talking with the teen provided by the HCP (see Appendix E). Arm 2 
intervention group parents whose teens do not have a scheduled well-child visit and are a 
part of the study because they had their medical certification form completed by a health 
care provider at a CHOP Primary Care Practice in the last 8 weeks will receive the 
intervention materials and provider “prescription” via mail and will receive an orientation of 
the materials by a trained RA health coach over the phone.  
 
Parent and teen participants randomized to the control groups will receive care as usual at 
their well-child visit. RAs will conduct a chart review to document whether or not the well-
child visit was completed (date/time).   
4.2.2.1 RA Orientation 
 
Greet family, move with parent to confidential/quiet location 
 
Confirm Assignment Status 
 
Provide orientation to intervention materials with parent, including discussion of “The 
Basics” materials  
 
Give parent hardcopy of materials  
 
Bring parent to the exam room with teen and HCP 
 
Give HCP indication of assignment status (color coded file folder) 
 
Complete clinic implementation fidelity checklist (Appendix F) 
 
4.2.2.2 Health Care Provider Endorsement 
 
Provide key messages (Appendix E) to parent and teen 
 
Provide intervention prescription (Appendix E) to parent 
 
4.2.3 Booster Call and T2 Survey (Intervention Parents only) (2 weeks) (T=2) 
4.2.3.1 Booster Call 
Approximately 2 weeks (-3 days/ + 2 weeks) after the well-child visit or health coaching 
phone call (arm 2), a trained RA health coach will place a “booster” phone call to the 
intervention group parents to finish reviewing materials / content that might not have been 
completed at the clinic visit and to discuss questions and concerns that the parent might 
have. Much of the flow of conversation will be guided by the individual parent.  If parents 
have not talked to the teen, the RA will discuss barriers to this happening and will initiate 
another booster call in approximately 2 weeks. This process will be repeated up to 3 times 
(i.e., booster calls will be repeated every 2 weeks for a total of 3 possible calls). 
The following procedures will take place during the Booster call: 
 
RA places call to parent and has discussion about materials and the status of the 
parent-teen talk 

 
  
 
 
 
14
 
If parent has NOT talked to the teen, RA will discuss strategies to overcome barriers 
and continue to place calls every 2 weeks, up to 3 total calls 
 
Complete booster call implementation fidelity checklist (Appendix F). 
 
4.2.3.2 T2 Survey 
The 2 week survey will be given to the parents in the intervention groups and can be 
administered at the time of the booster call or can be scheduled for another date to be 
completed via phone or via secure web-survey. 
 
4.2.4 Final Follow-Up Survey (approximately 4-6 months) (T=3) 
Approximately 4-5 months after the well-child visit, we will administer a parent and teen 
follow-up survey to all Arm 1 participants over the phone or via secure web-survey.   
 
Approximately 6 months after the well-child visit or health coach phone call (for Arm 2 form 
drop off group), we will administer a parent and teen follow-up survey to all Arm 2 
participants over the phone or via secure web-survey. 
 
4.2.5 Health Care Provider Feedback Survey  
After recruitment has ended, HCPs enrolled in the project will be asked to provide feedback 
about their “P4 Study” experience via an anonymous survey. HCPs will be made aware that 
the survey is part of the research study and by completing the survey they are giving their 
consent. It’s important that the surveys are completed anonymously so the HCPs feel 
comfortable sharing any negative feedback about research personnel and/or practice 
leadership. 
HCPs will have the option to complete the survey electronically (REDCap) or via hard copy 
(paper and pencil). Providers who choose to complete the paper and pencil version of the 
survey will be asked to place their completed surveys in a lock box/bin at the practice. 
Surveys will then be transferred via lockbox to 3535 Market Street where they will be 
entered into REDCap and stored in a locked filing cabinet.  
 
4.3 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They may 
also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to study treatment or visit schedules, or AEs. The Investigator may also 
withdraw subjects who violate the study plan, or to protect the subject for reasons of safety 
or for administrative reasons.  It will be documented whether or not each subject completes 
the clinical study. If the Investigator becomes aware of any serious, related adverse events 
after the subject completes or withdraws from the study, they will be recorded in the source 
documents and on the CRF. 

 
  
 
 
 
15
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 
Screening and Monitoring Evaluations and Measurements 
See Table 3 for a summary of T0-T3 measures. All assessment materials for all study arms 
and groups can be found in Appendices H-K. 
Table 3: Measure Summary for T0-T3 Surveys 
 
T0 
Baseline 
Intake  
T1 
Clinic/Phone 
Intervention 
T2 
2 Week  
Follow Up 
T3  
Long-Term  
Follow Up  
Measures 
T0 
Parent 
(I + C) 
T0 Teen 
(I+C) 
T1 RA 
T2 RA 
T2 Parent  
(I) 
T3 Parent 
(I+C) 
T3 Teen 
(I+C) 
Intervention Fidelity Assessment 
 
 
x 
x 
x 
 
 
Intervention Acceptability 
 
 
x 
x 
x 
x 
 
Intervention Feasibility 
 
 
x 
x 
 
 
 
Sociodemographics 
x 
x 
 
 
 
 
 
Social Desirability (Crowne Marlow) 
x 
x 
 
 
 
 
 
Relationship Characteristics 
 
 
 
 
 
 
 
   Child disclosure 
x 
+ 
 
 
 
 
 
   Parental Solicitation 
x 
+ 
 
 
 
 
 
   Parental Control 
x 
+ 
 
 
 
 
 
   Feeling Controlled 
 
x 
 
 
 
 
 
   Quality of Relationship 
x 
x 
 
 
 
 
 
   Perceived Trustworthiness (general) 
x 
x 
 
 
 
 
 
   Parenting  Style 
 
x 
 
 
 
 
 
   Parental Knowledge (general) 
 
x 
 
 
 
 
 
   Perceived Family Support 
 
 
 
 
 
 
^ 
Cognitive variables 
 
 
 
 
 
 
 
   Perceived HCP norms 
 
 
 
 
 
^ 
^ 
   Attitudes/Beliefs 
 
 
 
 
 
 
 
      Communication 
 
 
 
 
 
^ 
x 
      Parental Approval (ALC; Sex; TD) 
x 
x 
 
 
 
^ 
x 
   Knowledge 
 
 
 
 
 
X 
x 
   Self-efficacy 
 
 
 
 
 
^ 
X 
Communication 
 
 
 
 
 
 
 
   General (PACS) (Olsen) 
x 
x 
 
 
 
^ 
^ 
   PACS-STD/HIV (Sales 2008) 
 
 
 
 
 
 
^ 
   Strengths 
x 
x 
 
 
 
x 
X 
   Topic Specific-Quantity (ALC, Sex) 
 
 
 
 
 
^ 
x1 
   Topic-Specific Content (ALC, Sex) 
 
 
 
 
 
^ 
X 
   Communication Intentions 
 
 
 
 
 
^ 
 
Behavior 
 
 
 
 
 
 
 
   Parent (TD, ALC, Sex) 
x 
 
 
 
 
+ 
 
   Parental perception of teen (TD,ALC, 
Sex) 
x 
 
 
 
 
X 
 
   Teen (TD, ALC, Sex) 
 
x 
 
 
 
 
X1 
Behavioral Intentions (ALC, Sex) 
 
 
 
 
 
 
^ 
HCP Relationship 
 
 
 
 
 
 
 
   Future Visits 
 
 
 
 
 
^ 
^ 
*Note:  ALC=alcohol use; C= control; HCP= healthcare provider; I=intervention; PACS= Parent Adolescent Communication Scale; TD= 
teen driving; sex=sexual behaviors; ^=Arm 1 only; +=Arm 2 only; x=both Arm 1 and Arm 2 
1selected alcohol/sex questions will be asked of Arm 2 for exploratory purposes 
 
 
5.1.1 Confirmation of eligibility 
Members of the research team will securely document eligibility and consent for all subjects 
on hardcopies and retain the data directly in the REDCap electronic data capture system 
and/or locked filing cabinet. 

 
  
 
 
 
16
5.1.2 Contact Information 
The following contact information will be collected from both parents and teens (unless 
otherwise specified) (Appendix H): 
• 
First Name 
• 
Last Name 
• 
Home Address 
• 
Zip Code 
• 
Primary Phone Number 
• 
Secondary Phone Number  
• 
Additional Phone Number, if available 
• 
Email Address  
• 
Additional Email address, if available 
• 
Contact preferences (e.g., time of day and mode) 
• 
Date of Birth 
• 
Learner Permit Number, if applicable (teens only) 
After collecting the information, the research team will assign each subject a unique 
identification (UID) number. This UID will serve to code all subsequent data collection tools. 
5.1.3 Baseline Screening Intake Assessment (T0) 
The below information will be collected from parents and teens at the baseline assessment 
(see Appendix I). 
Parents will be asked to complete a secure web-survey or phone interview 
assessing: 
 
Parent Socio-demographics: Relationship to patient; Gender; Ethnicity; Race; 
Current marital status; Highest degree of education obtained. 
 
Relationship Characteristics (Stattin & Kerr, 2000; Kerr & Stattin, 2000): Child 
disclosure; Parental solicitation; Parental control; Quality of relationship with teen; 
Perceived general trustworthiness. 
 
Cognitive variables: Parental approval of adolescent behaviors. 
 
Communication Variables (Olsen; Crosby) General parent-teen communication; 
Communication about strengths. 
 
Parent behaviors: Driving; Alcohol. 
 
Parent perceptions of adolescent behaviors: Alcohol; Sexual behaviors; Driving. 
 
Social Desirability (Crowne-Marlow). 
Teens will be asked to complete a secure web-survey or phone interview assessing: 
 
Adolescent Socio-demographics: Sex; Ethnicity; Race; Grade in school. 
 
Relationship Characteristics (Stattin & Kerr, 2000; Kerr & Stattin, 2000): Feeling 
controlled; Quality of relationship with parent; Perceived general trustworthiness; 
Parenting style; Parental general knowledge. Child disclosure; Parental solicitation; 
Parental Control (Arm 2). 
 
Cognitive variables: Perceived parental approval of adolescent sexual/alcohol 
adolescent behaviors. 
 
Communication Variables (Olsen) General parent-teen communication; 
Communication about strengths. 

 
  
 
 
 
17
 
Adolescent behaviors: Driving; Alcohol; Sexual behaviors. 
 
Social Desirability (Crowne-Marlow). 
 
5.1.4 Health Coach Acceptability, Feasibility, and Fidelity Assessment 
A fidelity checklist will be completed by the RA Health Coach at the clinic visit (T1) and 
booster call (T2) (see Appendix F).  Items covered in the Health Coach Fidelity Assessment 
are listed below.  All data is collected by RA report, unless otherwise indicated. 
 
Health Coach sociodemographics: age, gender, ethnicity, race, degree of 
education (T1 and T2) (collected via HC survey) 
 
Health Care Provider sociodemographics:  age, gender, ethnicity, race, 
role/type, years in practice (collected via HCP survey) 
 
Health Care Provider familiarity with patient (# of visits between HCP and patient 
in past 5 years), # of patients seen per hour day of visit (T1) (collected via chart 
review by RA) 
 
Participant ID (T1 and  T2) 
 
Visit date/time/length (T1) 
 
Checklist of intervention materials distributed in clinic (T1) 
 
Checklist of intervention items distributed by health care provider during clinic 
visit (T1) 
 
Checklist of intervention items covered by health coach in clinic (T1) 
 
Checklist of intervention items covered by health coach in booster call (T2) 
Of note, further information to assess intervention fidelity will be collected from parents in 
the T2 Survey to confirm RA reports of intervention fidelity. 
In addition, all RAs will keep a running journal while at the clinic recording comments by 
clinic staff about intervention implementation issues, and all observations related to 
acceptability and feasibility of intervention implementation (T1). RAs will also record 
comments made by parents related to acceptability and feasibility of intervention during the 
2-week booster call / survey (T2). 
5.2 
Efficacy Evaluations 
5.2.1 2 Week Survey [2 weeks post clinic visit (- 3 days/ + 2 weeks)] (T2) 
Parents in the intervention groups will be administered a 2 week follow up survey containing 
the below items (Appendix J): 
 
Intervention Fidelity: Query about which materials parents received at the clinic 
 
Topic-specific Communication: how much did parent talk with the teen about the 
target behavior; when/how did talk take place and how did it go; Barriers to 
talking and methods for overcoming barriers; reasons for not having the talk and 
plans for having the talk in the future  
 
Intervention Acceptability: did parent use materials; helpfulness of materials  
 
Parent perceptions of adolescent participation and disengagement in their 
recent well-child visit  

 
  
 
 
 
18
5.2.2 Final Follow-Up Survey [4-6 months post clinic visit/health coach phone call] 
(T3) 
The below items will be assessed at the final follow-up with all parents and teens (see 
Appendix K).   
Parents will be asked to complete a secure web-survey or phone interview 
assessing: 
 
Cognitive Variables: Attitudes about parent-teen communication (Arm 1); Parental 
approval of adolescent sexual/alcohol behaviors (Arm 1); Parent knowledge of 
sexual health/alcohol related information (Arm 1) or teen driving safety information 
(Arm 2); Communication self-efficacy (Arm 1);  Perceive HCP norm  regarding 
parent-teen communication about sexual/alcohol behaviors (Arm 1).  
 
Communication Variables: General parent-teen communication (Arm 1); 
Communication about strengths; Parent-teen communication quantity and content 
about sexual health/alcohol (Arm 1) or teen driving (Arm 2); Communication 
intentions (Arm 1). 
 
Behavior: Parental perceptions of teen behavior; Parent practice driving behaviors 
(Arm 2) 
 
Communication Intentions. Intentions to communicate about sex/alcohol (Arm1). 
 
HCP Relationship: Likelihood of future visit to HCP for routine, sexual health, 
alcohol-related issues (Arm 1). 
 
Intervention Acceptability. 
 
Teens will be asked to complete a secure web-survey or phone interview about: 
 
Relationship Characteristics: Perceived family support (Arm 1). 
 
Cognitive Variables: Perceived parental approval of adolescent sexual/alcohol 
adolescent behaviors (Arm 1) and driving safety (Arm 2); Teen knowledge of sexual 
health/alcohol related information (Arm 1) or teen driving safety information (Arm 2); 
Self-efficacy related to sexual/alcohol behaviors (Arm 1); Perceived HCP norm -
communication about sexual/alcohol behaviors (Arm 1).  
 
Communication Variables: General parent-teen communication (Arm 1); 
Communication about strengths; Parent-teen communication quantity and content 
about sexual health/alcohol (Arm 1 and selected sexual/alcohol questions for Arm 2) 
or teen driving (Arm 2).  
 
Behavior: Teen behavior sexual/alcohol (Arm 1 and selected sexual/alcohol 
questions for Arm 2) or driving (Arm 2). 
 
Behavioral Intentions. For teens not engaging in target sexual/alcohol behaviors, 
intentions will be assessed (Arm1). 
HCP Relationship: Likelihood of future visit to HCP for routine, sexual health, 
alcohol-related issues (Arm 1). 
 
5.2.3 Healthcare Provider Feedback Survey 
The below items will be assessed at the Health Care Provider Feedback Survey with all 
HCPs who opt to complete the survey (see Appendix N).   
 
How things went during the study 
 
Suggestions for changes/future studies 

 
  
 
 
 
19
 
Impact on value of pediatric primary health care 
 
How to implement interventions like these in real life practice  
 
Any other helpful feedback  
 
5.3 
Safety Evaluation 
This is a minimal risk, behavioral intervention study. There are no expected serious adverse 
events related to the intervention or participation in this study. Any psycho-social risks are 
minimal and unlikely and will be monitored by reviewing and evaluating parent and teen 
periodic reports and by the timely reporting of any adverse events.  As with any research 
project, there is a risk to loss of confidentiality.  There are safeguards in place to protect 
confidential information including maintaining the master list in REDCap due to the internal 
controls already in place, keeping PHI separate from study data, and entering data directly 
into a secure database.  The study team has received a Certificate of Confidentiality from 
the National Institutes of Health to further protect subject confidentiality.   
As this study involves questionnaires related to sexual behavior, it is possible that research 
subjects will spontaneously disclose information related to statutory sexual assault. In this 
unlikely instance, the RA will immediately notify the PI.  If it is a teen that made the 
disclosure, the PI will make an assessment of the situation in collaboration with CHOP’s 
social work department in order to determine appropriate next steps and reporting 
requirements.  If it is a parent that made the disclosure, the RA will immediately notify the PI 
who will make an assessment and direct the parent to their child’s primary care physician 
for follow-up.  The PI will educate the RAs on Pennsylvania’s mandatory reporting 
requirements prior to conducting the trial.  

 
  
 
 
 
20
6 
STATISTICAL CONSIDERATIONS 
This is a pilot efficacy and implementation study. As such, some analyses may be 
underpowered and all analyses can be considered exploratory.  
6.1 
Primary Endpoint 
The primary endpoints are evaluating the difference between the intervention and control 
groups on adolescent health behaviors (alcohol, sexual, driving behaviors) and behavioral 
intentions (alcohol/sexual behavioral intentions). 
6.2 
Secondary Endpoints 
Secondary endpoints:  
 
Reach:  The proportion of eligible participants who agreed to participate in the 
intervention; of those that participated: the proportion of participants who read the 
materials, and talked with their teen about the indicated health topic. 
 
 
Feasibility of delivery in high volume clinic practice: Determine implementation 
quality (% of intervention components delivered with fidelity) and determine their 
association with clinic-level (e.g., patient volume) and provider-level factors (e.g., 
years of experience). These endpoints will be assessed via process measures. 
 
 
Evaluate the difference between the treatment and control conditions on: 
 
 
Parent-Teen Communication: General parent-teen communication; Topic-
specific quantity and content of parent-teen communication (sexual/alcohol/ 
driving/strengths); Parents’ communication self-efficacy; Parents’ 
communication intentions) 
 
Parent and Teen Topic-Specific Knowledge: Teen driving/sexual health/alcohol) 
 
Adolescent Perceptions of Parental Attitudes: Perceived parental disapproval of 
the teen having sex, drinking, and engaging in risky driving; Perceptions of the 
parent as a trustworthy source of information on sex, drinking/alcohol use, and 
teen driving 
 
HCP Relationship: Parent and teen  perception of  the importance HCP places 
on parent-teen communication; Parent and teen perception of HCP as resource 
for future routine, sexual health, and alcohol-related issues 
6.3 
Statistical Methods 
6.3.1 Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 
6.3.2 Efficacy Analysis 
The primary analysis will be based on an intention to treat approach. We will use 
descriptive and inferential statistical techniques. We will conduct preliminary analyses to 
make sure that the data are reasonable and to identify outliers. 

 
  
 
 
 
21
Descriptive statistics, such as means, standard deviations, medians and range for 
continuous variables and percentages for categorical variables will be generated for all 
quantitative data of the overall sample and by condition (treatment vs. control). Relevant 
continuous measures will be evaluated for normality and those differing markedly from 
normality will be summarized by using medians, interquartile ranges, and box-plots. 
Histograms will be the graphical measure used to complement descriptive analyses of 
categorical data.  
For statistical inference, we will employ a variety of parametric and non-parametric 
statistical techniques such as t-test, chi-square, Fisher’s exact test, linear and non-linear 
regression analysis, random effects models, generalized estimating equations structural 
equation modeling, will be used as needed. Some of the regressions may have to be run in 
the stepwise mode, with regression used in some steps to perform covariate adjustments of 
between-group comparisons. In other analyses, the regressions would be used as part of 
propensity analysis. Missing data approaches will be used. Statistical tests will be two tailed 
with an alpha = 0.05.  
Note that as this is a pilot study, we realize that we may be underpowered for some 
analyses. The conduct of these analyses remain important so that we can identify practice-
level effect sizes for the variables of interest. 
6.3.3 Safety Analysis 
All subjects randomized to receive an intervention (sexual health; alcohol; driving) will be 
included in the safety analysis. This is a minimal risk study and as such AEs and SAEs are 
not expected. However, AE incidence will be monitored and reported as necessary. 
6.4 
Sample Size and Power 
This is a pilot efficacy and implementation study. With this in mind we conducted an initial 
power analysis using observed effect sizes from prior RCTs of intervention materials (in 
non-clinic settings). Effect size estimates were taken from the TeenDrivingPlan RCT; 
treatment (n=86) vs control (n=65) (See Mirman et al., 2014 JAMA Peds) and from the 
Families Talking Together RCT; treatment (n=124) vs control (n=126) (see Guilamo-Ramos 
et al., 2010). 
Teen Driving Behavioral Outcomes 
 
The average amount of practice quantity (0 hrs. = 1; <1 hr = 2; 1 to 2hrs = 3; 3 to 5 
hours = 4; 6 to 10 hours = 5; > 10hrs = 6) across environments/conditions (parking 
lot, residential, highway, intermediate roads, rural roads, night, and bad weather). 
Effect sizes ranged from: (d=.50 to d=.34)  
 
The number of environments and conditions where the teen practiced for at least 1 
to 2 hours: TX: Med(IQR) = 6 (5,6) vs. Control: 5 (4,6).  
 
Teen-perceived support (5 pt scale), mean (SD): TX: 4.11 (.73) vs. Control: 3.78 
(.79);  (d=.43)  
 
Parent engagement (5 pt scale), mean (SD): TX: 3.51 (.54) vs. Control: 3.32 (.55); 
(d=.34)  
*The initial TDP trial found a 9% absolute risk reduction in the termination of on-road 
driving assessments, but we will not be administering on road driving assessment in the 
pilot study. 

 
  
 
 
 
22
Sexual Health Behavioral Outcomes 
 
Vaginal sex: TX 7% to 7% vs Control 6% to 22% (risk difference -15%) 
 
Freq of vaginal sex in past 30 days ((1 = never, 2 = once, 3 two or three times, and 
4 = once a week or more): TX 1.00 to 1.08 vs Control 1.00 to 1.53; (d=.5)  
 
Engaged in oral sex (proportion y/n): TX 3% to 4% vs Control 3% to 10% (risk 
difference -6%) 
 
Assuming a medium effect size (d=.5), desire to evaluate a difference between two 
independent means (two groups), an alpha of .05, power = .80, we will need 64 evaluable 
participants in each group. Assuming a smaller effect size of d=.34 the sample size 
increases to 137 in each group. To evaluate the difference in proportions (e.g., a 15% 
reduction in vaginal sex) using fisher’s exact test, an alpha of .05, power = .80 we need 94 
evaluable participants in each group.  
Given the pilot nature of this project these are acceptable in terms of establishing initial 
feasibility and proof of concept. 

 
  
 
 
 
23
7 
PATIENTS, PARENTS AND PROVIDERS PARTNERING TO PROMOTE 
ADOLESCENT HEALTH (P4) INTERVENTION  
7.1 
Description 
This is a clinic based psychoeducational intervention for adolescent patients and their 
parents to improve parent-teen communication about important health topics. The 
intervention is designed, if possible, to coincide with the adolescent patients’ well-child visits 
or providers’ completion of adolescent patients’ driver’s license medical certification form 
and consists of the following components: (1) In-person or over the phone orientation 
session with a trained RA Health Coach (HC) and parent, (2) Distribution of 
psychoeducational materials to the parent, (3) Endorsement and delivery of key messages 
from the health care provider, and (4) “Booster” phone call placed by the RA HC. 
7.1.1 Trained RA Health Coaches (HC) 
HCs will be members of the study team trained by the PI and Project Director. They will 
meet with parents of teens at the time of the teen’s well-child visit or over the phone to 
provide an orientation of the materials. HCs will provide hardcopies of the 
psychoeducational materials (section 7.1.2), deliver key messages, and work with the 
parent to identify a date and time to talk with the teen about the targeted health behavior 
using the “Basics” (see section 7.1.2 below) as a guide. The HC will place a booster phone 
call to the parent approximately 2 weeks after the clinic visit to re-deliver key messages, 
cover additional content as applicable, and discuss how the conversation with the teen 
went, providing support as needed. 
The goal of the HC conversations (face-to-face and phone calls) is to provide parents with 
the knowledge and skills to have meaningful and accurate information on important 
adolescent health topics and to motivate parents to speak with their teen about these topics 
by increasing self-efficacy and decreasing perceived barriers. 
7.1.2 Intervention Materials 
The materials consist of a Parent-Teen Communication Handbook that includes 7 modules 
on cultivating a positive parent-teen relationship and information on adolescent health and 
development. It also includes a workbook for structured communication activities “Things to 
do and things to talk about”. This is intended to serve as a “desk reference” for parents and 
is not necessarily something that they would be expected to read cover-to-cover. 
This information is complemented by stand-alone content specific modules on sexual 
health, alcohol prevention, and teen driving. Each behavior specific module has a brochure-
style handout called “The Basics”. The Basics provide parents with the essential information 
that they need to have a productive discussion with their teen about these important health 
behaviors. For the teen driving module we will use the TeenDrivingPlan Parent Guide in lieu 
of creating a new “Basics” brochure for teen driving. See Appendices A-D. 
7.1.3 Endorsement by Health Care Provider 
If intervention coincides with well-child visit, the health care provider will deliver key 
messages to the parents and teens and endorse the materials verbally, as well as 
document it on the health care provider endorsement sheet, and in the form of a written 
“prescription” (Appendix E). The written prescription can be mailed if intervention takes 
place over the phone. 

 
  
 
 
 
24
SAFETY MANAGEMENT 
7.2 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study by the PI.  
7.3 
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  
  

 
  
 
 
 
25
8 
STUDY ADMINISTRATION 
8.1 
Treatment Assignment Methods 
8.1.1 Randomization 
A table of random numbers will be used to allocate subjects into each arm of the study. At 
screening/enrollment research staff will access an electronic database with the allocation 
information for each Arm. 
8.2 
Data Collection and Management 
We will use REDCap for direct and secondary data entry and electronic survey data 
distribution and collection. REDCap will also be used for tracking of study procedures (e.g. 
consent/assent and eligibility) after having been documented on paper forms. Secondary 
data entry in REDCap will take place if HCPs chose to complete a paper and pencil version 
of the Health Care Provider Feedback Survey. HCPs will be asked to place their completed 
anonymous surveys in a lock box/bin at the practice. Only members of the study team will 
be able to access the completed Provider Feedback Surveys in the lock box. Surveys will 
then be transferred via lockbox to 3535 Market Street where they will be entered into 
REDCap and stored in a locked filing cabinet. REDCap has security features in place to 
protect the confidentiality of subject data.  Datasets will be stored on a secure shared drive 
that only members listed on the protocol can access. All data exports for analysis will be 
completely de-identified as the study data will not be collected with any identifying 
information. All identifying information will be stored in a separate REDCap tracking 
database and will not be exported with the study data being used for analysis. Any paper 
forms will be stored in a locked file cabinet in the PI’s administrative offices. 
We will protect subject confidentiality and ensure the data are secure in the following ways: 
1) 
Each subject will be assigned a unique identifier (UID) used in all data collection. 
2) 
Subject contact information will be stored in a secure REDCap database.  
Access to the identifiable data in REDCap will be limited to study team 
members. 
3) 
All files, forms, databases, and printouts will be available only to staff working on 
the study. All research staff will be CITI certified. 
8.3 
Confidentiality 
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers (including others at CHOP) before sharing a limited dataset. 
8.4 
Regulatory and Ethical Considerations 
8.4.1 Data and Safety Monitoring Plan 
This is a minimal risk study. Dr. Carol Ford, as the Principal Investigator, will be responsible 
for monitoring the safety of study subjects and complying with all reporting requirements. 
She will report any adverse events immediately to the CHOP IRB and to the sponsoring 
agency, if indicated by the IRB. 

 
  
 
 
 
26
8.4.2 Risk Assessment 
This is a minimal risk study consisting of the completion of self-report surveys, and 
receiving individualized coaching on topics that parents have previously identified as 
important and valued (Ford et al., unpublished data). Further, prior evaluations of these 
materials have demonstrated effectiveness in other settings. The control condition is usual 
practice / standard care with which there are no known risks (i.e., adolescents in the control 
group will receive the usual care typically provided to adolescent patients at the well-child 
visit). There are no physical or economic risks. The learning-to-drive period is the safest 
period for new drivers and no safety negative outcomes have ever been observed in our 
prior research with this population of learner drivers. 
8.4.3 Potential Benefits of Trial Participation 
We will not guarantee direct benefits associated with this study.  However, we are utilizing 
evidenced-based interventions that have been shown to improve parent-teen 
communication and impact teen health behaviors.  Therefore, participants may benefit from 
increases in parent communication skills, improved parent-teen-provider relationship 
dynamics, and positive health outcomes for the adolescent. Indirect benefits include 
participating to the development of effective adolescent healthcare materials. 
8.4.4 Risk-Benefit Assessment 
Because the study is minimal risk and there are potentially both direct and indirect benefits 
associated with participation, the benefits outweigh the risks.  
8.5 
Recruitment Strategy 
Prospective participants will be identified via EPIC. Parents of adolescent patients that will 
be 14-17 years of age at their upcoming scheduled well-child visit at a participating CHOP 
Primary care site will receive a letter in the mail describing the study. Additionally, 16-17 
year old patients will be identified by the participating primary care practice when patients 
drop off their medical certification form for the permit application to be signed by their 
CHOP primary care provider. A letter inviting the family to participate in the project will be 
given to the family when their completed medical certification form is returned. The letter 
will include study contact information and if a family is interested in getting more information 
or in participating they can call or email to inquire. All participants that do not reach out after 
receiving the study letter will be called by a member of the study team to describe the study 
and gauge interest in participating.  
8.6 
Verbal Consent to Screen & Informed Consent/Assent and HIPAA Authorization 
All interested parental participants will be asked to complete a brief verbal consent to 
screen for eligibility over the phone. We have requested a waiver of assent for the verbal 
consent to screen, as we will be able to obtain all relevant information from the parent 
directly. However, we will still collect verbal assent from the teens for the main study 
procedures.  
If participants are interested and meet all eligibility criteria, a member of the research team 
will collect parental consent and teen assent, as well as HIPAA Authorization over the 
phone prior to their well-child visit appointment. The study team member will speak to 
parents first, followed by teens. After speaking with parents we will ask that the teen to 
move to a quiet and private location in the home. Potential participants will be given as 
much time as they need to ask questions.   

 
  
 
 
 
27
It is possible that subjects who are 17 years of age at the time of enrollment could turn 18 
during the 6-7 months of study participation.  Because we are collecting DOB, subjects that 
will turn 18 over the course of the study will be identified during the baseline data collection 
visit.  At this time, the RA will schedule a follow-up phone call to re-consent these subjects 
when they turn 18.  During the re-consent call, the RA will explain that because the subject 
has turned 18 years old he/she is able to consent to participation in the research study for 
him/herself. The RA will proceed with the informed consent process as outlined above.  
8.6.1 Waiver of Documentation of Consent and Partial Waiver of HIPAA 
This research study meets the criteria for wavier of documentation of consent/assent under 
#46.117(c) (2). The research presents minimal risk to participants and involves no 
procedures for which written consent is normally required outside of the research context. 
All subjects will be given a study information letter (Appendix L); letters will be given in 
person at their well-child visit, mailed home, or emailed based on the families’ preference 
after enrollment.  As we are randomizing prior to the clinic visit it is too late to screen and 
consent at the time of the visit. We have kept research procedures (consent, surveys) 
separate from in office procedures so as not to disrupt the flow of the clinic and to gauge 
whether or not the intervention can be implemented with fidelity during normal clinical 
operations (see Secondary Aim section 6.2). 
Additionally, a waiver of documentation of consent is requested for the completion of the 
Health Care Provider Feedback Survey. The survey introduction contains language 
denoting that by proceeding with the survey the health care provider is giving their consent 
to participate.  
8.7 
Payment to Subjects/Families 
All parents will be compensated $10 for completing the Intake Survey and $20 for 
completing the final follow-up survey.  Intervention group parents will be compensated $5 
for completing the 2 week survey.   
All adolescents will be compensated $10 for completing the Intake Survey and $20 for 
completing the final follow-up survey. 
If subjects do not complete all study procedures, they will be compensated less in 
proportion to the number of activities completed. 
 
 
 
 
 
 
 
 

 
  
 
 
 
28
 
 
 
 
 
 
 
9 
PUBLICATION 
CHOP investigators will have complete access to all study data and will publish results of 
the study in the form of manuscripts which will be submitted to the peer-reviewed scientific 
literature in journals relevant to the topic area. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  
 
 
 
29
 
 
 
 
 
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APPENDIX 
A: Parenting Educational Materials  
B: Sexual Health Educational Materials 
C: Alcohol Prevention Educational Materials 
D: Teen Driving Educational Materials 
E: Provider Endorsement & Prescription  
F: Health Coach Fidelity Assessment 
H: Contact Surveys 
I: Intake Baseline Surveys 
J: 2 Week Follow-Up Survey 
K:  Final Follow-Up Survey  
L:  Study Information Letter 
M: Resource List 
N: Health Care Provider Feedback Survey