Making Friends With Yourself: a Depression Prevention Program for Adolescents
Phase: NA
Conditions: Depression Mild, Resilience, Psychological, Adolescent Behavior
Sponsor: University of North Carolina, Chapel Hill

 
 
Making Friends with Yourself: A Depression Prevention Program for 
Adolescents 
 
 
 
NCT number NCT03270943 
Document Date 03/01/2021 
 

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STUDY PROTOCOL  
Making Friends With Yourself: A Depression Prevention 
Program For Adolescents 
Short Name: The S.M.A.R.T. Project:  Stress Management and Resilience Training for Teens  
 
UNC Program on Integrative Medicine 
UNC Department of Physical Medicine & Rehabilitation 
Email: smartstudy@med.unc.edu | Phone: (919) 445-6105 

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STUDY PROTOCOL 
Making Friends with Yourself: A Depression Prevention 
Program for Adolescents 
Short Name: The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens 
A trial designed to refine and feasibility-test a mindfulness-based self-compassion intervention and an 
attention-control intervention with 80 adolescents with subsyndromal depression.  
Principal Investigator:  
Susan Gaylord, PhD 
Director of the UNC Program on Integrative Medicine, Associate Professor, Department of 
Physical Medicine & Rehabilitation 
Supported by:  
The National Center of Complementary and Integrative Health 
Grant Number: 1 R34 AT008822-01A1 
Study Intervention Provided by:  
Not applicable 
Sponsor of IND (IDE):  
Not applicable 
 
 
 
 
 
 
 
 
 
 
 

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TOOL REVISION HISTORY 
Version 1.1 
Version Date:  1 March 2021 
Summary of Revisions Made:    
 
The PROMIS Pediatric Depression Scale was used as the measure in the time-to-event analysis 
because it was collected weekly rather than only 5 times at irregular intervals like the SMFQ.  
 
Christine Lathren added as a Research Associate to supervise the Project Manager. 
 
Version 1.0 
Version Date:  3 January 2020 
Summary of Revisions Made:    
 
Section __: Inclusion/Exclusion 
a. Removed lower limit for QIDS due to QIDS, DISC-IV, clinical assessment, SMFQ, and 
PROMIS not all measuring the same levels of depression. 
 
The team decided not to hold an orientation session, so as to reduce burden on the parents and 
adolescent participants. The content of the control group curricula was updated.  Study Pages 
site was added. The name of the study was changed to ensure that participants are blinded to 
what the investigators consider the active intervention. The two programs will be described as 
two different programs to reduce stress and enhance well-being in high school students. 
Updated consents and measures are added. 
 
Changes to the Safety Plan necessitated an update to the protocol. Chloe Brown is added as a 
research assistant. 
 
Version 0.1 
Version Date: 1 July 2015 
Summary of Revisions Made:  
 
Initial master protocol 
 
 

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TABLE OF CONTENTS 
TOOL REVISION HISTORY ....................................................................................................................3 
Version 1.0 ................................................................................................................................................ 3 
Version 0.1 ................................................................................................................................................ 3 
TABLE OF CONTENTS ..........................................................................................................................4 
TABLE OF TABLES ...............................................................................................................................8 
STUDY TEAM ROSTER ....................................................................................................................... 10 
Principal Investigator .............................................................................................................................. 10 
Co-Investigators ...................................................................................................................................... 10 
Project Manager, Study Coordinator, and Research Assistants ................ Error! Bookmark not defined. 
Consultants ................................................................................................ Error! Bookmark not defined. 
PARTICIPATING STUDY SITES ............................................................................................................ 11 
PRÉCIS ............................................................................................................................................. 11 
Study Title ............................................................................................................................................... 11 
Objectives ............................................................................................................................................... 11 
Design and Outcomes ............................................................................................................................. 11 
Interventions and Duration .................................................................................................................... 11 
Sample Size and Population ................................................................................................................... 12 
1. STUDY OBJECTIVES ....................................................................................................................... 12 
1.1: Primary Objective ............................................................................................................................ 12 
Specific Aim 1 ..................................................................................................................................... 12 
1.2: Secondary Objectives ...................................................................................................................... 12 
Specific Aim 2 ..................................................................................................................................... 12 
Specific Aim 3 ..................................................................................................................................... 13 
2. BACKGROUND AND RATIONALE ................................................................................................... 13 
2.1: Background on Condition, Primary Study Focus ............................................................................. 13 
2.2: Study Rationale ................................................................................................................................ 13 
The Impact of Depression in Adolescence ........................................................................................ 13 

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Changes in Adolescence and the Onset of Depression. ................................................................... 14 
Theoretical Explanations for Depression and Mechanisms of Change............................................ 14 
Behavioral Programs for Depression Prevention in Adolescents .................................................... 15 
Mindfulness-based Self-Compassion: An Antidote for Depression? ............................................... 15 
Development of a Mindfulness-based Self-Compassion Program for Adolescents with 
Subsyndromal Depression: “Making Friends with Yourself” ........................................................... 16 
Rationale for use of an active comparison group as an attention control ...................................... 17 
Preliminary Studies ............................................................................................................................ 17 
3. STUDY DESIGN ............................................................................................................................. 19 
3.1: Recruitment, screening and consent ............................................................................................... 20 
Recruitment ....................................................................................................................................... 20 
Screening ............................................................................................................................................ 20 
4. Selection and Enrollment of Participants ....................................................................................... 21 
4.1: Inclusion Criteria .............................................................................................................................. 21 
4.2: Exclusion Criteria ............................................................................................................................. 22 
4.3: Study Enrollment Procedures .......................................................................................................... 22 
4.3.1: Phone Screening and Psychological Exam .............................................................................. 23 
4.3.2: Consenting ............................................................................................................................... 23 
4.3.3: Documentation ........................................................................................................................ 23 
4.3.4: Randomization......................................................................................................................... 23 
5. STUDY INTERVENTIONS ................................................................................................................ 23 
5.1: Interventions, Administration, and Duration .................................................................................. 23 
5.1.1: Prevention Programs ............................................................................................................... 23 
5.1.2: Measurement Time Points ...................................................................................................... 25 
5.1.3: Measures ................................................................................................................................. 25 
5.1.3 Modifications after First Two Cohorts ........................................................................................... 29 
5.2: Handling of Study Interventions ...................................................................................................... 29 
5.2.1: Masking ........................................................................................................................................ 29 
5.3: Concomitant Interventions .............................................................................................................. 29 
5.3.1: Allowable Interventions ............................................................................................................... 29 

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5.3.2: Required Interventions ................................................................................................................. 29 
5.3.3: Prohibited Interventions .............................................................................................................. 30 
5.4: Adherence Assessment ................................................................................................................... 30 
6. STUDY PROCEDURES .................................................................................................................... 30 
6.1: Schedule of Evaluations ................................................................................................................... 30 
6.2: Description of Evaluations ............................................................................................................... 30 
6.2.1 
Screening Evaluation .......................................................................................................... 30 
6.2.2: Enrollment, Baseline, and/or Randomization .......................................................................... 31 
6.2.3: Follow-up Visits ........................................................................................................................ 31 
6.2.5: Completion/Final Evaluation .................................................................................................... 32 
7. SAFETY ASSESSMENTS .................................................................................................................. 33 
7.1: Specification of Safety Parameters .................................................................................................. 33 
7.2: Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ......................... 33 
7.3: Adverse Events and Serious Adverse Events ................................................................................... 33 
7.3.1: Definitions ............................................................................................................................... 33 
7.3.2: Classification of AE Severity .................................................................................................... 34 
7.3.3: AE Attribution Scale ................................................................................................................ 34 
7.4: Reporting Procedures ...................................................................................................................... 34 
Detection of increased depression. .................................................................................................. 36 
7.5: Follow-up for Adverse Events .......................................................................................................... 36 
7.6: Safety Monitoring (See DSMP) ........................................................................................................ 36 
7.6.1: Frequency of Review ............................................................................................................... 36 
7.6.2: Review Materials ..................................................................................................................... 36 
7.6.3: Summary report ...................................................................................................................... 37 
8. INTERVENTION DISCONTINUATION............................................................................................... 37 
8.1:  Discontinuation of Intervention for a Participant .......................................................................... 37 
8.2: Possible reasons for discontinuation of the whole study ............................................................... 37 
8.3: Early discontinuation ....................................................................................................................... 37 
8.4: Normal end to the study ................................................................................................................. 37 
9. STATISTICAL CONSIDERATIONS ..................................................................................................... 37 

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9.1: General Design Issues ...................................................................................................................... 37 
9.2: Sample Size and Randomization ...................................................................................................... 38 
9.2.1: Treatment Assignment Procedures ........................................................................................ 38 
9.3: Definition of Populations ................................................................................................................. 38 
9.4: Interim Analyses and Stopping Rules .............................................................................................. 38 
9.4.1: Study-wide stopping rules ...................................................................................................... 38 
9.4.2: Individual stopping rules ......................................................................................................... 38 
9.4.3: Additional Reasons for Withdrawal of a Participant ............................................................. 39 
9.5: Outcomes ........................................................................................................................................ 39 
9.5.1: Primary Outcome  ................................................................................................................... 39 
9.5.2: Secondary Outcomes............................................................................................................... 39 
9.6: Data Analyses .................................................................................................................................. 40 
9.6.1 Exploratory analyses of outcomes and mediators. ................................................................. 40 
9.6.2:  Feasibility Analyses ................................................................................................................ 40 
10. DATA COLLECTION AND QUALITY ASSURANCE ............................................................................ 42 
10.1: Data Collection: Data Type, Personnel Collecting Data ................................................................. 42 
10.2: Data Management ......................................................................................................................... 42 
10.3: Quality Assurance .......................................................................................................................... 42 
10.3.1: Training .................................................................................................................................. 42 
10.3.2: Quality Control Committee ................................................................................................... 43 
10.3.3: Metrics ................................................................................................................................... 43 
10.3.4: Protocol Deviations ............................................................................................................... 43 
10.3.5: Monitoring ............................................................................................................................. 43 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY .............................................................................. 44 
11.1: Institutional Review Board (IRB) Review ....................................................................................... 44 
11.2: Informed Consent Forms ............................................................................................................... 44 
11.3: Participant Confidentiality ............................................................................................................. 44 
11.4: Study Discontinuation ................................................................................................................... 44 
12. COMMITTEES ............................................................................................................................. 44 
13. PUBLICATION OF RESEARCH FINDINGS ................................................ Error! Bookmark not defined. 

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14. REFERENCES ............................................................................................................................... 44 
Appendices ...................................................................................................................................... 55 
Appendix I.a: Phone Consent (version 0.3, 7 June 2017) ....................................................................... 56 
Appendix I.b: Parent Consent (version 0.3, 1 June 2017) ...................................................................... 61 
Appendix I.c: Child Assent (ages 14-17) (version 0.3, 1 June 2017) ....................................................... 64 
Appendix I.d: Adult Consent (version 0.3, 1 June 2017)......................................................................... 67 
Appendix II.a: QIDS-SR ............................................................................................................................ 70 
Appendix II.b: Diagnostic Interview Schedule for Children- Version IV (DISC-IV) .................................. 74 
Appendix II.c: Adolescent Survey Measures ......................................................................................... 102 
Short Mood and Feelings Questionnaire (SMFQ-C) ......................................................................... 102 
Brief Resiliency Scale (BRS) .............................................................................................................. 103 
Adolescent Cognitive Style Questionnaire (ACSQ) ........................................................................... 104 
Ruminative Response Style scale-brooding factor (RRS-B) .............................................................. 110 
Test for Self-Conscious Affect for Adolescents (TOSCA-A) ............................................................... 111 
Self-Compassion Scale (SCS) ............................................................................................................. 117 
Child and Adolescent Mindfulness Measure (CAMM) ..................................................................... 119 
Adolescent Demographic Questions ................................................................................................ 120 
Appendix II.d: Parent Survey ................................................................................................................ 121 
Short Mood and Feelings Questionnaire (SMFQ-P) ......................................................................... 121 
Parent Demographics Questions ...................................................................................................... 122 
Appendix II.e: PROMIS Pediatric Short Form (version 1.1) .................................................................. 125 
Appendix II.f: Expectation of Benefit / Credibility ................................................................................ 126 
Appendix II.g: Daily Diary ...................................................................................................................... 127 
Appendix III: Recruitment ..................................................................................................................... 128 
Flyer .................................................................................................................................................. 128 
Email Announcement ....................................................................................................................... 129 
Appendix IV: Data Safety Monitoring Plan (version 0.3, 23 May 2017) ............................................... 130 
TABLE OF TABLES 
Table 1. Results for mean differences of low and high self-compassion on indicators of wellbeing ......... 17 
Table 2. Study measures ............................................................................................................................. 28 

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Table 3. Schedule of Evaluations ................................................................................................................ 30 
 
 

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STUDY TEAM ROSTER  
Principal Investigator 
 
Susan A. Gaylord, PI,  Department of Physical Medicine and Rehabilitation, 183 Wing D, 
C.B.#7200, 170 Manning Drive, UNC School of Medicine, Chapel Hill, N.C.  27599-7025. Phone: 
919-966-8586, email:   gaylords@med.unc.edu 
Co-Investigators 
 
Keturah R. Faurot, Co-I,  Department of Physical Medicine and Rehabilitation, 173 Wing D, 
C.B.#7200, 170 Manning Drive, UNC School of Medicine, Chapel Hill, N.C.  27599-7025. Phone: 
919-966-8586, email:   faurot@med.unc.edu 
 
Chirayath M. Suchindran, Co-I, Department of Biostatistics , CB # 7420, 3103-A, McGavran-
Greenberg Hall,  Gillings School of Global Public Health, Chapel Hill, NC 27599-7420. Phone: 919-
966-7258, Fax: 919-966-3804, email: suchi@bios.unc.edu 
Project Manager, Study Coordinator, and Research Assistants 
 
Nandie Elhadidy, Research Assistant, Project Manager as of June 19th, 2020  Department of 
Physical Medicine and Rehabilitation, 184 Wing D, C.B.#7200, 170 Manning Drive, UNC School of 
Medicine, Chapel Hill, N.C.  27599-7025. Phone: 919-966-8586, email: nandie98@email.unc.edu  
 
Chanee Lynch, Project Manager until June 18, 2020, Department of Physical Medicine and 
Rehabilitation, 183 Wing D, C.B.#7200, 170 Manning Drive, UNC School of Medicine, Chapel Hill, 
N.C.  27599-7025. Phone: 919-966-8586, email:   chanee_lynch@med.unc.edu 
 
Christine Lathren, Research Associate,  Department of Physical Medicine and Rehabilitation, 184 
Wing D, C.B.#7200, 170 Manning Drive, UNC School of Medicine, Chapel Hill, N.C.  27599-7025. 
Phone: 919-966-8586, email: nandie98@email.unc.edu  
Consultants 
 
John F. Curry, Co-I, Department of Psychology and Neuroscience, Box 90086, 417 Chapel Drive, 
Duke University, Durham, NC 27708-0086. Duke University, Durham, NC. Phone: (919) 681-
0020, email: john.curry@duke.edu  
 
April Harris-Britt, Co-I, AHB Center for Behavioral Health and Wellness, 3326 Durham Chapel Hill 
Blvd, Suite D, Durham, North Carolina 27707 
(919) 586-8018 x1001 Email: ahb@ahbpsych.com  
 
 
 
 

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PARTICIPATING STUDY SITES 
Primary Site: University of North Carolina, School of Medicine and Health Care System, 101 
Manning Drive, Chapel Hill, North Carolina, 27599. 
PRÉCIS  
Study Title  
Making Friends with Yourself: A Depression Prevention Program for Adolescents (aka The S.M.A.R.T. 
Project: Stress Management and Resilience Training for Teens) 
Objectives  
The primary objective of this research project is to refine, manualize, and test the feasibility of the a 
mindfulness-based self-compassion program and an attention control program focused on developing 
healthy behaviors known to reduce depressive symptoms (e.g., exercise, healthy food choices, sleep 
hygiene, relationship skills) for 14-17 year-old adolescents with subsyndromal depression. Refinement of 
procedure manuals for adolescent participants and instructors will ensure that future interventions are 
delivered in a consistent and reproducible fashion. 
A secondary objective is to test the feasibility of randomizing participants to the two educational 
programs. Results will guide the development of an adequately powered clinical trial in terms of 
recruitment needs and logistics; subjects’ acceptance of the treatment and control programs; 
equivalence of the credibility of the two programs; and subjects’ willingness to complete assessment 
instruments, adhere to study protocols, and complete the study.    
Another secondary objective is to explore primary and secondary outcomes and mediators in response 
to the mindfulness-based program, including incident depression (primary outcome), change in 
depressive symptoms and resilience (secondary outcomes) and rumination, negative cognitive style, and 
shame (potential mediators). 
Design and Outcomes   
Four cohorts of adolescents, each with 20 participants, will be recruited. In each cohort, twenty 
individuals will be randomized with 10 each in the mindful self-compassion group (Making Friends with 
Yourself) and the healthy behavior skills group. In addition, each adolescent will be accompanied by a 
parent (n=80).  Adolescents complete brief weekly questionnaires to assess depressive symptoms as 
well as a longer set of online questionnaires at baseline, weeks 4 and 8 of the intervention, and 3 and 36 
weeks post-intervention. Parents complete a questionnaire at baseline, 3 and 36 weeks post-
intervention. 
Interventions and Duration  
Both education intervention groups meet once a week for 1 hour and 45 minutes for 8 weeks. After 
completion of the program, there will be monthly sessions in the continuation phase (90 minutes per 
session) for 36 weeks.  

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Sample Size and Population  
The sample will include 80 adolescent high school students with subsyndromal depression, defined as 
having symptoms of major depression that are not of sufficient severity to meet diagnostic criteria of 
major depression disorder (MDD).  
1. STUDY OBJECTIVES 
1.1: Primary Objective 
The primary goal of this research project is to refine and test the feasibility of the “Making Friends with 
Yourself” program, as well as a credible attention control program, involving education and discussion 
on healthy behaviors, for 14-17 year-old adolescents with subsyndromal depression and to compare the 
feasibility of the two interventions1.  
The proposed study will randomize high school aged adolescents (aged 14-17, participants may turn 18 
after enrollment) with subsyndromal depression to an eight-week program of the proposed prevention 
program, entitled “Making Friends with Yourself” (MFY), or an attention-control group that focuses on 
healthy behaviors. 
Specific Aim 1 
Refine and manualize the mindful self-compassion program, “Making Friends with Yourself” (MFY), and 
a credible attention control program among adolescents. Refinement of procedure manuals for 
adolescent participants and instructors will ensure that future interventions are delivered in a consistent 
and reproducible fashion. 
Purpose 1 
Refinement of procedure manuals for adolescent participants and instructors will ensure that future 
interventions are delivered in a consistent and reproducible fashion. 
Our group has developed the MFY program as a developmentally-appropriate adaptation of Neff 
and Germer’s Mindful Self-compassion program. The MFY program has been piloted with healthy 
adolescents and showed promise as an intervention for reducing depressive symptoms. Further 
adaptation will target an adolescent population with subsyndromal depression.  
1.2: Secondary Objectives 
Specific Aim 2  
To test the feasibility of an exploratory clinical trial involving a mindful self-compassion intervention, the 
MFY program (treatment group), and a comparison attention-control among 14-17 year old adolescents 
(participants may turn 18 after enrollment) with subsyndomal depression. Study results will guide the 
development of an adequately powered clinical trial in terms of recruitment needs and logistics, 
equivalence of credibility of the two programs, and participants’ willingness to complete assessment 
instruments, adhere to study protocols, and complete the study.    
Purpose 2 
Study results will guide the development of an adequately powered clinical trial in terms of 
recruitment needs and logistics; subjects’ acceptance of the treatment and control programs; 

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equivalence of credibility of the two programs; and subjects’ willingness to complete assessment 
instruments, adhere to study protocols, and complete the study.    
Specific Aim 3 
With feasibility being tested in Aim 2, we will explore primary and secondary outcomes and mediators in 
response to the MFY program in Aim 3, including time to incident depression by the time of the 36-week 
follow-up (i.e., MDD-major depressive disorder) (primary outcome); resilience, change in depressive 
symptoms (secondary outcomes); and rumination, negative cognitive style, and shame (potential 
mediators). 
Purpose 3  
This study intends to analyze, in an exploratory fashion, the following:  incident depression (primary 
outcome); change in depressive symptoms and resilience (secondary outcomes); and rumination, 
negative cognitive style, and shame (potential mediators). 
Measures are collected at baseline, halfway through the 8-week course, after completion of each 8-
week program, at 22 weeks post-program, and at 36 weeks post-program. Analyses are conducted 
to inform the planning of an adequately powered randomized controlled trial.   
2. BACKGROUND AND RATIONALE  
2.1: Background on Condition, Primary Study Focus 
The rate of depression increases markedly over the course of adolescence3. Currently 20-25% of 
adolescents experience a depressive episode before they graduate high school. In 2012 alone, 14% of 
girls and 5% of boys age 12-17 experienced a major depressive disorder, with only a third of those 
seeking treatment28. Due to the number of adolescents untreated for symptoms, and the ability of these 
symptoms to interfere with developmental processes2 and lead to other clinical disorders29, depression 
in adolescence increases the risk for maladaptive behaviors5,6. Since depression often first appears in 
adolescence and unsuccessful treatment of adolescent depression increases the risk of chronic or 
recurrent depression in adulthood, managing depression symptoms at this critical stage of development 
can benefit mental health and functioning throughout the lifespan9.    
2.2: Study Rationale 
 
The Impact of Depression in Adolescence 
Adolescents struggling with depression are often set on a maladaptive behavior trajectory which may 
lead to academic challenges, substance abuse, risky sexual behavior, impairment in relationship 
building, and suicidality30-34. They are also more likely to experience negative somatic health outcomes 
such as migraine headaches35 and obesity36. Depressive symptoms are associated with sleep 
disturbances (e.g. insomnia and hypersomnia), exacerbating the negative impacts on health and social 
domains37. These difficulties often persist into adulthood34,38,39. Adolescent depression was shown to 
predict poorer health, higher health-care utilization, low levels of social support, and increased work 
impairment due to physical health over the subsequent decade35,40. Adolescent depression may also 
result in an altered educational trajectory (i.e., dropping out of high school, change of type of post-
secondary school) 41. Those who experienced even subsyndromal depression, defined as evidencing 

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symptoms of major depression, but not of the severity to meet a diagnosis of major depression42, have a 
higher risk of developing major depressive disorder (MDD) as adolescents 43and are two to three times 
more likely to experience depression as adults39,44,45;  depression in adults has been associated with 
lower lifetime income and socioeconomic status, welfare dependency, and fewer occupation 
options33,46-48.   
Changes in Adolescence and the Onset of Depression 
During adolescence, individuals undergo rapid physiological growth49-51 including changes in both 
structure and function of the brain52. Coupled with these physiological changes are new cognitive 
abilities including the capacity for metacognition and the ability to think abstractly, which promote 
adolescents’ increasingly complex and sophisticated ways of relating to their world53. Taken together, 
such changes often have dramatic effects on the ways in which adolescents perceive, understand, and 
interpret their daily experiences, particularly those that occur in social and emotional domains. Identity 
exploration, characteristic of this stage of development54, may lead adolescents to self-reflect and to 
consider their relationship with others and their role in society. As they compare themselves with their 
peers, adolescents often engage in self-doubt and self-criticism55, which may contribute to a negative 
self-image and self-consciousness56,57. Additionally, due to these physical and cognitive changes, 
reflected in peer evaluation and greater awareness of gender roles, adolescents often experience 
increased shame58,, as well as increased stress and poor coping skills. 
Theoretical Explanations for Depression and Mechanisms of Change 
Theoretical underpinnings 
of depression in 
adolescence explain that 
cognitive vulnerability, and 
specifically negative 
cognitive style, predicts 
depression through an 
interaction with stressful 
events. According to 
hopelessness theory59, 
individuals with negative 
attribution styles perceive 
stressful events as due to 
persistent and immutable causes, as having further stressful consequences, and as being precipitated by 
their own lack of worthiness. Therefore, when an individual with a negative cognitive style experiences a 
painful or challenging event, he s/he tends to hold him/herself responsible for the cause, assumes that 
this negative experience will recur repeatedly, and that this same experience will generalize to multiple 
situations60. Numerous studies provide evidence that negative cognitive style predicts depression in 
adolescents61-63. Personality types prone to self-criticism or in need of others’ approval are also 
predisposed to depression64. Additionally, self-critics have less of an ability to self-soothe in times of 
stress65, and this inability has been linked to depression66-69.  In addition, shame has been linked to 
depressive symptoms in various adolescent populations58,70-75.  At times emerging from repeated self-
criticism, shame is defined as a global negative evaluation of the self, resulting in a sense of a shrinking, 

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small, powerless and worthless self75, and a concern that the self will be exposed as defective76. Shame 
is experienced as stable and unremitting over time, and shame-prone individuals often exhibit a 
negative cognitive style70,77-79. 
Rumination, a method of coping with negative mood, has been described as having two components: 
reflection and brooding. Brooding is characterized by repetitive focus on negative emotions and has 
been linked to depressive symptoms80. In addition, rumination, in general, has consistently predicted 
increases in depressive symptoms in children and adolescents81-84. Finally, resilience, or the ability to 
bounce back from stress85, has been negatively associated with depression in numerous studies85,86 and 
can serve as a protective factor from depression87. 
Behavioral Programs for Depression Prevention in Adolescents 
Several depression-prevention programs have been developed for youth. These have included cognitive 
behavioral therapy (CBT)88-98, psycho-educational interventions99-101, problem solving102,103, and 
behavioral skills training interventions (e.g., interpersonal relationship building and social skills)94,99,104-
106. A meta-analysis of depression-prevention programs for youth reported that only 41% of the 
programs included in the study had significant reductions in depressive symptoms post intervention and 
the effect sizes were small (r = .15 pre to post; r = .11 pre to follow-up)9. Additionally, many of the trials 
had either waitlist or assessment-only control conditions, which are likely to overestimate effect sizes 
(e.g., one study that compared a CBT treatment group with four active control groups and a waitlist 
control found that all active controls and CBT outperformed the waitlist control107). Furthermore, only 4 
of 47 trials produced significant reductions in future depression onset9. 
The lessons learned from these depression-prevention programs have implications for future program 
design. For example, the most effective programs utilized professional interventionists (rather than 
classroom teachers), assigned homework, and were relatively short in length9. Also, the developmental 
appropriateness of CBT for adolescents has been questioned, as these youth may not be able to fully 
grasp the concepts foundational to CBT. Third-wave therapies such as Acceptance and Commitment 
Therapy and Dialectical Behavior Therapy, although popular in clinical practice, have few well-controlled 
clinical trials108. Based on the mixed success of well-studied behavioral interventions, there is a need to 
investigate new approaches to depression prevention that are tailored to the developmental needs of 
the adolescent population.  
Mindfulness-based Self-Compassion: An Antidote for Depression?   
One promising approach is mindfulness-based self-compassion training. Mindfulness has been defined 
as paying attention to the present moment with nonjudgmental awareness109. It includes recognition of 
thoughts or emotions that are in one’s momentary experience and subsequently “letting go” of those 
emotions or thoughts, acknowledging that they are transitory110. Mindfulness-training interventions, 
most notably Mindfulness-Based Stress Reduction (MBSR)25,teaches skills that increase one’s ability to 
be more mindful in everyday life. In adults, these studies are conclusively shown to lower depression111-
116 and in one meta-analysis, a robust effect size was reported for mindfulness interventions on 
improving mood in individuals with diagnosed depression (Hedges g = .95)117. 
Although mindfulness research with adolescents is nascent, studies show that greater mindfulness is 
indicative of improved psychological wellbeing. A recent meta-analysis on mindfulness interventions 
with youth reported a moderate effect size (Cohen’s d=.37) for psychological symptoms, and a large 

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effect size for studies that used a clinical sample (Cohen’s d=.50)118.  Specifically, post-intervention, 
depression was shown to decrease in a clinical sample17 and rumination decreased in 4th and 5th grade 
public school students119. Mindfulness was correlated negatively with perceived stress in one study15, 
and mindfulness training resulted in decreased stress in clinic-referred adolescents in another study17. 
Other studies found significantly improved overall wellbeing120 and decreased depressive symptoms121.  
Both mindfulness and self-compassion independently contribute to improvements in psychological 
health122. Self-compassion, as defined by Neff26, is described as being open and present to one’s own 
suffering, to actively heal oneself with kindness, and to understand that one’s suffering is inherent in the 
human experience and as such is shared among others. Neff defines three components of self-
compassion: mindfulness, or maintaining perspective amidst challenging circumstances; common 
humanity, or recognizing that one is integrally connected to a network of imperfect human beings, and 
self-kindness, or treating oneself with tenderness when one is suffering26.  Greater self-compassion is 
associated with lower depression, anxiety, and stress in both adults13,123-133 and adolescents22-24 and self-
compassion is lower in high school females than both high school males and middle school females24.  
Self-compassion has also been shown to predict lower depression symptomology over a 5-month 
interval13, supporting the theory that "self-compassion represents a potentially important protective 
factor for emotional problems such as depression." (p. 33).  
Neff and Germer developed the Mindful Self-compassion program (MSC) for both clinical and non-
clinical applications14. MSC meets weekly for 8 weeks, and involves didactic instruction as well as 
practice of self-compassion exercises. A clinical trial of this program has demonstrated significant 
decreases in anxiety, depression (large effect size compared to wait-list control), and stress that were 
maintained at both 6 and 12 month follow-up14.  A similar program, developed for patients with mood 
disorders, resulted in marked decreases in depression134. At UNC, in collaboration with our colleagues at 
University of California-San Diego (UCSD), we have developed a mindfulness-based self-compassion 
program for adolescents and tested it in a non-clinical, teen population.   
Development of a Mindfulness-based Self-Compassion Program for Adolescents with 
Subsyndromal Depression: “Making Friends with Yourself”  
This R-34 proposes to refine and test the feasibility of a mindfulness-based self-compassion training 
program for adolescents who are experiencing subsyndromal depression, comparing it with a “healthy 
lifestyles” group program, which is based on a program developed by our group as a control condition 
for mindfulness studies with adolescents, and which will be adapted in length and content as a 
comparison attention-control for the treatment intervention. Our mindfulness-based self-compassion 
program, “Making Friends with Yourself”, adapts the MSC format and contains elements of it. It is 
guided by the three components of self-compassion26: self-kindness, common humanity, and 
mindfulness. It differs from the adult program in that classes will be shorter, developmentally 
appropriate (e.g., more activity-based such as games and role-plays), includes a component about the 
adolescent brain, a mindful movement segment halfway through each class, and shorter meditations. 
Treating oneself kindly and experiencing oneself as part of a common humanity is posited to shift 
negative cognitive style so that inferences related to self are less negative. Developing these qualities is 
also hypothesized to decrease shame. Keeping perspective in the midst of difficult moments 
(mindfulness) is posited to also shift negative cognitive style, as well as decrease brooding (negative 
rumination). Further, both shame and rumination are known to correlate with negative cognitive 

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style70,77-79,135-137. These changes in negative cognitive style, shame, and brooding are hypothesized to 
decrease depression and increase resilience.  
Rationale for use of an active comparison group as an attention control  
This healthy behaviors control group, identical to the mindful self-compassion group in form and 
structure, was first piloted in an adolescent mindfulness study by this group and was found to be both 
credible and acceptable among participants (see preliminary studies). It has been tested as a 6-session 
course with community adolescents, and results from the Borkovec and Nau credibility scale138 indicated 
no difference in adolescents’ perceived credibility between the control and intervention programs. We 
are now proposing to expand it to eight sessions and test it with a different population, specifically 
adolescents with subsyndromal depression. For this project, with our clinician coinvestigators, we will 
expand and refine this program, in order to develop a suitable control condition for a future RCT. The 
program is similar to lifestyle group programs offered to at-risk adolescents by Co-I April Harris-Britt, 
PhD.   
Preliminary Studies                                                                               
In the past two years, our group has investigated outcomes associated with mindfulness training for 
adolescents and has developed and piloted a prototype of a mindfulness-based self-compassion 
program for adolescents. In the first study, one aim was to determine how a self-report measure of self-
compassion correlated with self-reported emotional wellbeing and impacted response to a lab social 
stressor.  Male and female adolescents (n=28) ages 13 to 18 were randomized to a six-week mindfulness 
program adapted for teens entitled “Learning to Breathe” or an attention-control intervention, “Healthy 
Lifestyles”, which involved education and discussion about ways in which they might make more healthy 
choices in relation to behavior (e.g. nutrition, sleep, exercise). Participants completed a teen-adapted 
Trier Social Stress Test (TSST) in a lab setting, with physiological stress assessed via salivary cortisol, 
heart rate, blood pressure, and heart rate variability at baseline, during the TSST, and during recovery 
along with measures of perceived stress, life satisfaction, positive and negative affect. We analyzed the 
TSST for induction of a significant stress response, and assessed meaningful differences (Hedges’ g > .20) 
between the groups. Those in the high self-compassion group (equal to or above the median) self-
reported greater emotional wellbeing across all measures than those in the low self-compassion group 
(below the median) (Table 1).  
Table 1. Results for mean differences of low and high self-compassion on indicators of wellbeing 
Mean (SD)
LSC
(n = 12) 
HSC
(n = 16) 
Hedge’s g (95% CI)
Anxiety
36.50 (8.25)
31.75 (6.38)
0.64 [-0.11, 1.38]
Perceived Stress
32.08 (5.66)
27.50 (7.76)
0.64 [0.11, 1.39]
Negative Affect
24.50 (7.72)
20.62 (6.67)
0.53 [0.21, 1.27]
Positive Affect
29.67 (6.02)
31.19 (8.19)
-0.20 [-0.91, 0.53]
Life Satisfaction
2.33 (0.38)
2.72 (0.65)
-1.18 [-0.93, 0.53]

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In addition, those in the high self-compassion group had a lower physiologic stress response when 
exposed to the TSST than those in the low self-compassion group. Figure 2 depicts differences between 
high and low self-compassion groups in change in systolic blood pressure in response to the TSST.   
In our second study, we developed and 
pilot-tested a prototype of Making Friends 
with Yourself, adapted from the Neff & 
Germer Mindful Self-Compassion program 
for adults. We used a mixed-methods 
wait-list control in which participants 
completed online measures of 
mindfulness, self-compassion, and 
dimensions of emotional wellbeing 
measures before and after the course. 
Most notably, we found a 25% decrease in 
depressive symptoms in the intervention 
group, in addition to statistically significant 
changes in all measures except life 
satisfaction, social connectedness, and positive affect. In the waitlist control condition, no significant 
pre-post differences were present in any of the measures (Figure 3). Together, changes in mindfulness 
and self-compassion  significantly predicted changes in depression, perceived stress, anxiety, and life 
satisfaction post-intervention (p<.05).    
Interestingly, at baseline, the link between stress and depression was stronger in those with low self-
compassion compared to those with high self-compassion (β = -.31, p = .02), indicating that these low 
self-compassionate adolescents may more easily become depressed when faced with stress. This 
finding, linked with findings from the first study, indicate that adolescents with low self-compassion are 
likely to be more easily stressed and therefore more easily depressed.    
Impact 
Depression among 
adolescents is a prevalent 
and growing public health 
problem, the consequences 
of which have significant, 
long-term negative impacts 
for the individual, their 
families, and society. This 
innovative project, in a 
high-priority NCCIH area, 
will test the feasibility of a 
promising, novel, 
depression-prevention 
program adapted from a 
Note. CI = Confidence interval; LSC = Low Self-Compassion; HSC = High Self-Compassion * p < 0.1
 
Figure 2. Change in Systolic Blood Pressure during 
Trier Tasks 
 
Figure 3. Change in Measures of Mindfulness, Self-compassion, and 
Dimensions of Emotional Wellbeing Measures 

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successful adult Mindful Self-Compassion program.  “Making Friends with Yourself” (MFY) will be refined 
and manualized, as well as feasibility-tested in an exploratory clinical trial, in adolescents who 
experience subsyndromal depression. It will also refine and test the comparative feasibility of an 
attention-control condition, piloted by our team in a mindfulness intervention for adolescents, to be 
adapted as a control intervention for this study. The measures selected for feasibility testing are 
theoretically meaningful and likely able to elucidate mechanisms by which either program impacts 
depressive symptoms. This information can be used to plan a future randomized trial. Reinforcing the 
potential impact is the collective extensive experience of the investigative team, including their 
experience with this population and in designing, implementing, and evaluating similar studies, as well 
as the supportive research environment of the University of North Carolina at Chapel Hill.  If this 
manualized program proves acceptable, feasible and efficacious, there is great potential for its use in 
schools and other adolescent settings, thus amplifying its potential impact on reducing depression by 
enhancing the lives of adolescents and those who care for them.  
3. STUDY DESIGN 
In this study, we will refine and feasibility-test our mindful self-compassion program and an attention 
control program with a focus on adolescents who are experiencing subsyndromal depression. 
Subsyndromal to mild depression is defined as a score of at least 6 and 10 on the Quick Inventory of 
Depressive Symptoms (QIDS). The intervention program, called “Making Friends with Yourself” (MFY), 
implements mindfulness and self-compassion training. The control condition is a healthy lifestyle 
program for high-school aged adolescents. The control condition was developed by our team as an 
attention control group for our pilot adolescent mindfulness program and will be adapted for 
comparison with the MFY intervention. The 8-week programs will be piloted with a total of 80 
adolescents. After completion of the 8-week program, the teens will participate in a post-group meeting 
to give feedback about program contents. Feedback will take place in the form of a focus group. 
Following the 8-week program, adolescents will be invited to participate in 6 monthly continuation 
sessions, designed to strengthen understanding of the topics presented in the 8-week course. Measures 
of depression, resilience, brooding, shame, mindfulness, and self-compassion will be obtained before 
the 8-week program, halfway through the program, after the 8-week program (intervention phase), and 
3 and 36 weeks after program completion (continuation phase). Feedback from program participants 
will inform modifications and refinement of both programs.  
Our primary goal is to examine the feasibility of implementing the program. After feasibility, the primary 
outcome to be explored will be the occurrence of incident major depressive disorder (MDD) with a 
secondary outcome to be explored being the trajectory of depressive symptoms over time (measured at 
baseline, program end and at 3 and 36 weeks post program) using the Short Mood and Feelings 
Questionnaire (SMFQ) administered to both the adolescent and a parent. Studies indicate high 
predictive validity in adolescent self-report of depression139,140. The study psychologist will contact 
parents of teens with incident major depression, captured by the SMFQ at any of the scheduled time-
points during the study, for referral to appropriate mental health care.  
Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, 
they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer 
program which utilizes a random number generator with a permuted block design to ensure that the 

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number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will 
continue through 4 cohorts of adolescents (n=80). During participation, adolescents will keep a daily 
online diary, accessible from a cell phone, to document homework practice. Their engagement in the 
program will be captured by audiotaping program sessions. After each program’s completion, 
adolescents will participate in a focus group to 
give feedback about program contents. The 
adolescents will be invited to participate in 6 
monthly continuation sessions, designed to 
strengthen understanding of the topics presented 
in the 8-week course. After the first two cohorts, a 
post-participation interview and questionnaire will 
capture additional feedback about the program.   
The research assistant will transcribe audio-taped 
data from sessions and focus groups. The team 
will combine this data with feedback provided in 
diaries, interviews, and post-participation 
questionnaires. This will be analyzed using 
qualitative methods to inform revision of specific 
program components and the revision of detailed 
program manuals for future programs. 
3.1: Recruitment, screening and consent  
Recruitment 
We will recruit adolescents who are experiencing 
subsyndromal depression in three ways:   
1) Discussions with local guidance counselors and school personnel;  
2) University-wide emails to the University community; and  
3) Flyers posted in local high schools/community boards (a successful strategy in our preliminary 
studies).  
Members of our study team have established relationships with personnel in several of the local school 
systems. This has been successful in meeting targeted recruitment numbers in previous research 
studies.  
Screening 
If an adolescent or parent is interested in the study, they can begin the screening process through the 
following ways: 
1) Phone: interested participants can initially contact the study team by calling the contact number 
directly; 
2) Email: interested participants can initially contact the study team through the study’s email 
(smartstudy@med.unc.edu); 

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3) Study Website: parents of interested participants can initially contact the study team through 
the study website (http://smartstudy.web.unc.edu/parent-survey/);  
The study team will explain the study to interested parents and, with permission, arrange for the 
adolescent to complete the online screening, which includes the Quick Inventory for Depressive 
Symptomology (QIDS). Adolescents who meet pre-screen eligibility criteria (see Section 4. Selection and 
Enrollment of Participants) and their parent will then meet with a study team member to review study 
procedures in detail and provide informed consent and assent (see Section 4.3: Study Enrollment 
Procedures and Section 6.2: Description of Evaluations). Potentially eligible adolescents and a parent will 
then meet with the Study Psychologist for a clinical mental health assessment. 
4. Selection and Enrollment of Participants 
4.1: Inclusion Criteria 
Participants must meet all of the inclusion criteria to participate in this study. Inclusion criteria for the 
study includes: 
 
Adolescents between ages 14-17. Adolescents may turn 18 after enrollment. 
 
Adolescents who are in high school. 
 
Adolescents with access to a smartphone or internet-enabled device. 
 
Adolescents and parent willing for their adolescent to be randomized to one of the two groups. 
 
Adolescent able to attend group sessions (8 weekly, 1.75 hour sessions; 6 monthly, 1.5 hour 
sessions) and complete study assessments. 
 
Adolescents experiencing subsyndromal depression assessed by: 
o Completion of screening questions by parent (see Parent Screening Survey and 
Telephone Consent); 
o Completion of QIDS by adolescent (see ; 
o Completion of clinical mental health assessment based on Diagnostic Interview Schedule 
for Children for Children (DISC-IV) by a study provider. The clinical mental health 
Figure 5. Flow of Interested Participants through the Screening Process
Interested Person
Participants recruited 
through  schools or self-
referrals
Permission to 
Contact
Participants can provide 
permission online via 
StudyPages or verbally, if 
the participant contacts the 
study directly.
Telephone 
Screen
A study team member 
provides info about the 
study and conducts a brief 
eligibility review with 
parent and teen.
QIDS 
Depression 
Screen
A study team member 
sends QIDS  survey to 
participant. After 
completed, it is 
reviewed and baseline 
appointment is set up if 
criteria met.

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assessment will screen for serious psychiatric illness, including major depression (MDD), 
suicidality, and other exclusion criteria. 
Preliminary identification of subsyndromal depression will occur through screening questions completed by 
the parent (see Telephone Consent for details) and completion of QIDS by adolescent.  
Adolescent and parent willing to receive a clinical mental health assessment, administered by a study 
provider, based on the Diagnostic Interview Schedule for Children-IV (DISC-IV) to screen for serious 
psychiatric illness, including major depression (MDD) and suicidality.  
4.2: Exclusion Criteria 
All candidates meeting any of the exclusion criteria at baseline will be excluded from study 
participation. Exclusion Criteria include: 
 
Adolescent and parent unable to speak, write, and read in English. 
 
Adolescents who have received prior mindfulness training (such as a mindfulness course).  
 
Adolescent unable or unwilling to attend or  participate in group sessions and/or self-report 
assessments. 
 
Adolescents with the presence of suicidality or MDD as determined by clinical exam. 
Adolescents who have experienced MDD in the past will not automatically be excluded from the 
study. 
 
Adolescents with active substance abuse, defined as active treatment for substance abuse, legal 
consequences/school suspensions associated with substance use, or ongoing family conflict 
associated with substance use. 
 
Adolescents with a history of bipolar disorder, schizophrenia, severe autism/intellectual 
disability, or psychiatric hospitalization within the past 36 weeks. Milder forms of mental health 
and/or developmental disorders will not automatically constitute exclusion. The Study 
Psychologist will recommend exclusion only if the disorder would lead to disruption of the group 
process. 
 
Adolescents who currently or previously participated in a research intervention to address 
depression or psychiatric conditions. Adolescents are allowed to see their mental health 
provider while participating in the study. 
4.3: Study Enrollment Procedures  
We will recruit teens, ages 14-17, who are in high school and have subsyndromal depression, in several 
ways including:  
 
Emails with study information sent to the University community; 
 
Local guidance counselors made aware of the study;  
 
Flyers posted in the community and at local schools; 
 
In-person recruitment at local teen community organizations, churches, and school events 
(such as parent-teacher associations or parent-teacher organizations). 

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4.3.1: Phone Screening and Psychological Exam  
The study staff will contact interested parents and, with consent and assent, conduct an initial 
telephone screen with the adolescent. If still interested, materials will be sent to the parent to share 
with the adolescent, describing the study as two programs to help teens to reduce stress and feel more 
positive about themselves. Candidates will be given the QIDS assessment and if their score is at least 6, 
the teen and a parent will be eligible for a visit with the Study Psychologist for a clinical mental health 
assessment.  
4.3.2: Consenting  
If a teen is eligible to participate based on the QIDS, the parent and teen will meet with a study team 
member to review study procedures in detail and provide written informed consent and assent.  Any 
questions asked by the parent and or teen will be answered accordingly. They may decline, sign, or take 
the consent home with them to be signed later. The adolescent will considered to be a subject after 
both the Informed consent is signed by the parent and the assent is signed by the teen.  
At that time, if consented, the teen and parent will meet with the Study Psychologist for a psychological 
exam, including a face-to-face administration of the Diagnostic Interview Schedule for Children (DISC-
IV). The clinical mental health assessment will determine continued eligibility. 
4.3.3: Documentation 
The study team will maintain a screening log on REDCap (a secure, web-based research database) 
throughout the study. This will include names, dates of contact, and outcomes of the recruiting effort 
for each candidate. At all stages of the recruitment process, the study team will store any written 
documentation securely in locked study cabinets.  
4.3.4: Randomization 
Although the study is not designed as an RCT, we do plan to test our randomization system. In all but the 
first two cohorts, as soon as 14-20 eligible adolescents qualify for enrollment, they will be allocated to 
one of the educational groups, using a specially-designed computer program (in REDCap). This program 
requires the operator to check off inclusion/exclusion criterion for each subject and confirm that 
subjects have been consented. The program utilizes a random-numbers generator with a permuted 
block design (blocks of 2 to 4) to ensure that the numbers of subjects allocated to the two arms over 
time are equal and to conceal the allocation. Randomization is stratified by gender. 
5. STUDY INTERVENTIONS  
5.1: Interventions, Administration, and Duration  
5.1.1: Prevention Programs 
Each program will be 8 weeks in length and meet weekly for 1.75 hours per session. The week before 
the programs begin, each subject and parent will complete baseline measures through an electronic 
interface (REDap survey). A trained instructor, assisted by a mental health provider (including mentored 
psychologist/social work interns or school counselors) who work with adolescents will lead each 
program. Mental health providers or their supervised students will identify any behaviors that may 
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Making Friends with Yourself Program undergo extensive training through the Center for Mindful Self-
Compassion and the University of California, San Diego. Instructors of the control program are 
experienced health behavior specialists, preventive medicine physicians, health teachers in the schools, 
or school counselors. Continuation sessions, 90-minutes in length, will occur monthly through the first 
six months to review the skills taught in the sessions and to encourage continued practice of techniques 
learned in the program. Each program session will be audio-recorded to ensure program fidelity and to 
enable assessment of the value of specific study components. The study curriculum will include in-class 
didactic training and exercises, group discussion, hands-on class activities that reinforce the ideas 
presented, and homework assignments designed to encourage participants to practice what they have 
learned. 
Making Friends with Yourself Curriculum 
The MFY program will be led by an experienced mindful self-compassion instructor trained in teaching 
the teen program and assisted by a mental health provider who works with teens. The curriculum will be 
adapted from the adult program in that it will be developmentally appropriate for adolescents. The 
team has developed a Chatbot for the study to reinforce concepts that are learned in class. For example, 
participants can choose emotion words to express how they are feeling in a given moment; the chatbot 
will then provide them with a short practice to help them be mindful and self-compassionate.  
The MFY curriculum will contain the following:  
 
Session 1: Discovering Mindful Self-Compassion: Definitions of mindfulness and self-
compassion will be provided. Guided meditation is presented. Through a hands-on exercise, 
students become familiar with the concept that we treat ourselves more harshly than we 
treat our friends in time of difficulty. 
 
Session 2: Paying Attention on Purpose: Mindfulness concept is presented. Sound 
meditation, eating meditation, and a body scan are introduced. 
 
Session 3: Lovingkindness: Concept of lovingkindness is introduced, along with 
lovingkindness practices. Included is how to tailor lovingkindness practices to meet one’s 
own personal needs. 
 
Session 4:  Self-Compassion: Definition of self-compassion is articulated through guided 
meditations and exercises. Music meditation is introduced. 
 
Session 5:  Self-Compassion vs. Self-Esteem: The similarity and differences of these two 
ways of relating to oneself are presented.  
 
Session 6:  Living Deeply: The compassionate voice is contrasted with the voice of the Inner 
Critic. An art and writing activity is incorporated into the lesson. 
 
Session 7:  Managing Difficult Emotions: Adolescents are taught specific tools to deal with 
particularly emotionally challenging situations, i.e., those that potentially could increase 
anxiety or depression.  
 
Session 8:  Embracing Your Life: Focus is on how to integrate gratitude and self-appreciation 
practices into daily life. 
 
Continuation sessions, 90-minutes in length, will be held monthly and revisit aspects of the class 
content.  

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Healthy Lifestyles Group (HLG) 
An experienced facilitator will lead the HLG curriculum and will be assisted by a mental health provider. 
The program focuses on the development of healthy lifestyles for adolescents. Each session involves the 
introduction of the weekly topic by the facilitator followed by hands-on activities and discussion. A 
mobile friendly website will be explored to help reinforce concepts learned in this class and participants 
will complete homework related to the class content. The HLG curriculum will contain the following 
topics, adjusted with feedback from the participants:  
 
Session 1: Sleep hygiene: The science behind sleep and its effects on the brain   
 
Session 2: Nutrition: Eating well for a healthy body and healthy mind 
 
Session 3: Exercise: Getting moving to feel better 
 
Session 4: Academic Stress: Overcoming School Stress 
 
Session 5: Social media—Instagram, Twitter and beyond: How to manage this in your life 
without it overtaking your life  
 
Session 6: Creativity: Shaping your Environment 
 
Session 7: Diversity: Exploring your Identity 
 
Session 8: Community service: Engaged Citizenship 
Continuation sessions, 90-minutes in length, will be held monthly and revisit aspects of the class 
content. 
5.1.2: Measurement Time Points 
Adolescents will be evaluated at baseline (Visit 2), halfway through the intervention (Visit 6), after the 
intervention (Visit 10), in the middle of the continuation phase (Visit 13), and after the continuation 
phase (Visit 16). Parents complete the SMFQ-P evaluating their perception of their child’s depressive 
symptoms at baseline (Visit 2), post-program (Visit 10), and the continuation visits (Visit 13 and Visit 16). 
The PROMIS Pediatric Depression Scale, originally designed as a safety measure, is employed as the 
time-to-event measure. 
5.1.3: Measures 
Several measures will be used for the study. Table 2 lists each measure, the construct(s) it assesses, and 
the timepoint it is administered in the study. 
Measures Used For Pre-Screening 
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)141: Adolescents will complete 
the QIDS self-report as a screening measure for depression. The sixteen-item QIDS is highly correlated 
with the full Inventory of Depressive Symptomatology and is limited to the nine DSM-IV domains: 1) sad 
mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep 
disturbance; 8) appetite change; 9) psychomotor changes. The QIDS is a reliable (α=.86) measure141 that 
compares favorably with other depression measures142 and has been investigated in adolescents143. A 
score of 6-10 is consistent with subsyndromal to mild depression. The QIDS will be completed following 
the telephone screen to determine eligibility to come in for an enrollment visit. 
Diagnostic Interview Schedule for Children- Version IV (DISC-IV)144: The DISC-IV assesses psychiatric 
diagnoses of children and adolescents by eliciting the diagnostic criteria specified in the Diagnostic and 
Statistical Manual of Mental Disorders – Fourth Edition (DSM-IV) and the WHO International 
Classification of Diseases, Version 10 (IDC-10). The DISC is a highly structured interview for children and 

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adolescents aged 6 to 18, or their parents. The DISC was designed to be administered by lay interviewers 
following a training manual. Questions are worded so that they can be answered “yes”, “no”, and 
“somewhat” or “sometimes”. The DISC-IV is used as a guide by study clinicians  to assess study eligibility 
at the enrollment (baseline) visit.  
PROMIS Pediatric Depression Scale.  The Patient Reported Outcomes Mesurement Information System 
was funded and promulgated by the National Institutes of Health as a way to harmonize across 
measures.  They included measures specifically for pediatric populations, including adolescents.  One 
such measure is the pediatric depression short form.   The short form was chosen as a safety measure 
for this study because of its simplicity, its brevity (8 questions), and its ability to be administered and 
scored electronically using REDCap.  Because it was administered weekly, it also serves as an excellent 
measure to use for a time-to-event analysis. 
Short Mood and Feelings Questionnaire (SMFQ)145: The SMFQ is a depression scale created for children 
and adolescents. There is a 13-item youth version (SMFQ-C) and 13-item parent version (SMFQ-P). 
Items are symptoms of depression experienced over the past 2 weeks which the child or parent would 
endorse as “not true”, “sometimes true” or “true”. Internal reliability has been reported as α=.85 
(SMFQ-C) and α=.87 (SMFQ-P)146,147.  
Brief Resiliency Scale (BRS)85: This scale defines resiliency as the ability to “bounce back” and recover 
from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly 
disagree) to 5 (strongly agree). Convergent and discriminant validity have been established, and 
Cronbach’s alpha is between .80 and .91. Test-retest reliability over one month has been reported as .69 
and >22 weeks as .62.  
Adolescent Cognitive Style Questionnaire (ACSQ)148: The ACSQ assesses the extent to which 
adolescents utilize a negative cognitive style. Twelve hypothetical negative event scenarios are 
presented that are relevant to teens, and the participant is asked to write down one potential cause for 
the event. Participants then rate the degree to which the cause is 1) internal, 2) stable, and 3) global, the 
likelihood for future negative consequences to occur as a result, and the degree to which the result 
implies that the self is flawed. Construct validity was supported through correlations with other 
attributional style measures and depressive symptoms, and the scale demonstrated internal consistency 
(α =.95) and test-retest reliability (.73 over 2 weeks). Reliability and validity remain consistent with using 
as few as four scenarios. This study uses six of the twelve scenarios (items 1, 2, 3, 6, 8, and 12) that are 
relevant to the study population. Items not as relevant (e.g. attending college, having a boss) or that 
were redundant (e.g. questions dealing with boyfriends/girlfriends or grades) were not included for this 
study to reduce participant burden with answering questions.  
Ruminative Response Style scale – brooding factor (RRS-B)80,149: Five items from the 22 original items of 
the Ruminative Response Style questionnaire will be used in this study reflecting the tendency to dwell 
on negative emotions and potential consequences. Brooding is the component of rumination that 
correlates most strongly with depression. On a scale from 1 (never/almost never) to 4 (always/almost 
always), participants are asked to indicate how often they would initiate a specific response when they 
were upset. The 5-item scale has been used previously in a study with adolescents and correlate highly 
with the full rumination scale (r=.93); internal consistency for this shortened scale was good (α=.82) and 
test-retest reliability was good150. 

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Test for Self-Conscious Affect for Adolescents (TOSCA-A)151: This scale was developed to assess 
proneness to shame, proneness to guilt, externalization of blame, detachment-unconcern, and pride in 
self and pride in behavior. The scale is comprised of 15 scenarios (10 negative, 5 positive) that might 
occur in the everyday life of an adolescent. Participants are asked to indicate on a 5-point scale their 
likelihood of reacting with each response. TOSCA is correlated with measures of anger, empathy, and 
psychological symptoms, and internal consistency was good (shame, α =.77; guilt, α =.81) 
Self-Compassion Scale (SCS)124 (26 items): The self-compassion subscales are self-kindness, common 
humanity, and mindfulness. Participants indicated their responses to each item using a 5-point scale 
ranging from 1 (almost never) to 5 (almost always). Construct validity was established through expected 
correlations with the self-criticism subscale of the Depression Experience Questionnaire, the Social 
Connectedness scale, and the attention, clarity, and repair subscales of the Trait-Meta Mood Scale. 
Internal consistency for this scale was found to be excellent (α = .93).   
Child and Adolescent Mindfulness Measure (CAMM)16: CAMM assesses mindful awareness and 
acceptance. Participants indicate their responses to 10 items using a 5-point scale ranging from 0 (never 
true) to 4 (always true). Construct validity was established through positive correlations with measures 
of quality of life, academic competence, and social skills and negative correlations with measures of 
somatic complaints, and internalizing and externalizing behavior problems; adequate internal 
consistency also was found (α = .80). 
Expectations of Benefit / Credibility (CRED)138,152: This instrument, administered at the end of the first 
class,  provides an assessment of expectation of benefit and credibility of each intervention using an 
adaptation of a validated scale previously developed for psychological studies for purposes of comparing 
two treatment arms. Participants respond to 6 items on a 9-point scale ranging from 1 (not at all) to 9 
(very much). Psychometric testing supported high internal consistency within each factor (expectation, α 
= .90; credibility, α = .86) and good test-retest reliability (.83). 
Feelings About the Class: This is a process questionnaire developed for Gregory Clarke’s “Coping with 
Stress” program to assess subjects’ feelings about the instructors and other class participants as well as 
satisfaction with the program.  It will be administered at the end of the intervention phase (at the last 
class) for both programs with permission of the author. 
Home Practice Completion (Daily Diary): Adolescents in the intervention program will be expected to 
practice concepts taught in the class. Each day, they will receive a text message (or email) from the 
study team.  Embedded in the text or email will be a link to the diary website. The daily diary will consist 
of no more than 5 short questions about skills they practiced, number of minutes they practiced, and 
any barriers to practice. 
Patient-Reported Outcomes Measurement Information System Pediatric Short Form (PROMIS 
Pediatric Short Form): The PROMIS Pediatric Short Form is a short 12-item survey designed to screen for 
depression. The PROMIS Pediatric Short Form will be used as a safety measure once participants are in 
the 8-week course to assess any changes in depressive symptoms. See 7. Safety Assessments for more 
details about the PROMIS Pediatric Short Form being used as a safety measure for the study. A T score 
of 70 on the PROMIS depression measure will generate a referral to the study psychologist. 

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Demographics: The study is limited to adolescents experiencing subsyndromal depression. The 
demographic survey, administered at baseline, will collect data about each teen’s age, gender, 
race/ethnicity, years of education, and parental educational attainment. 
Qualitative measures: We will collect two types of formal qualitative data: 1) Evaluation (focus) groups 
following each 8-week set of classes at the end of the last class; 2) Transcriptions of audio-recorded 
classes. The focus groups will address the following topics related to the teens’ experience with the 
programs, including:  
1) Most memorable aspects of program (e.g. most favorite and least favorite aspects); 
2) Whether they would recommend it to a friend;  
3) Usefulness, challenges and recommended changes including in-class and out-of-class 
assignments;  
4) Usefulness of the program for management of stress, mood, and well-being in daily life;  
5) Tools that might help them maintain practices; and  
6) Unfulfilled expectations of the program.  
 Each focus group will be audio-recorded and transcribed. 
Table 2. Study measures
 
 
MEASURE 
CONSTRUCT 
TIMING 
Inclusion/Exclusion Criteria 
QIDS-SR 
Depression screening 
Pre-screening 
Diagnostic Interview Schedule for Children (DISC-
IV) 
Screening for serious 
psychopathology 
Screening visit 
Primary Outcomes 
PROMIS Pediatric Depression Short Form v1.1 
Incident major depression 
Weekly from the beginning of the 
intervention 
Secondary Outcomes 
Short Mood and Feelings Questionnaire (SMFQ-C) 
Depression scores change 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 
Brief Resiliency Scale (BRS) 
Resiliency 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 
Exploratory Mediating Measures 
Adolescent Cognitive Style Questionnaire (ASCSQ) 
Cognitive Style 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 
Rumination Response Style-brooding factor (RRS-B) 
Brooding 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 
Test of Self-conscious affect-adolescence (TOSCA-A) 
Shame 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 
Process Measures 
Home-practice (HW) 
Homework completion 
Daily during program, then weekly 
Pediatric Depressive Symptoms Short Form (PDS) 
Safety assessment for depression 
Weekly during program 
Self-Compassion Scale (SCS) 
Self-compassion 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 
Child and Adolescent Mindfulness Measure 
(CAMM) 
Mindfulness 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 
Credibility Scale (CRED) 
Expectation of benefit 
Following first class 
Feelings about the class 
Post-participation evaluation 
Visit 16 
Post-participation focus group 
Program evaluation 
Visit 10, Visit 16 

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5.1.3 Modifications to the interventions 
After the programs, adolescents will participate in a focus group to give feedback about program 
contents. The adolescents will be invited to participate in 6 monthly continuation sessions, designed to 
strengthen understanding of the topics presented in the 8-week course. Measures of depression, 
resilience, brooding, shame, mindfulness, and self-compassion will be obtained before, halfway through, 
and after the program as well as at 22 weeks and 36 weeks after the program.  
Feedback from program participants and their parents will inform modifications and refinement of both 
programs. Once this has been completed and program manuals updated, an additional 2 cohorts will be 
recruited. 
5.2: Handling of Study Interventions  
A Manual of Operations will be actively maintained to document subject participation in all aspects of 
the project including, for examples, attendance at weekly session visits, completion of homework and 
online assessments, and follow up questionnaires. 
5.2.1: Masking  
The nature of the interventions tested in this study does not allow for masking of subjects, instructors, 
or other personnel involved in program delivery. To preserve unbiased outcome assessments, study 
personnel involved in clinical assessments or data analysis will be masked with respect to group 
assignment. To minimize differences in subject expectancy, the programs will be described to 
participants as two programs, both of which have been previously found to be beneficial to teens. 
Participants will not know the name of the group: Making Friends with Yourself or Healthy Lifestyle 
Group. The intent is to prevent the participant from knowing which program the investigators believe is 
most likely to prevent depression. To verify that adolescents assigned to either group have the same 
expectation of benefit, participants will be asked to complete a Credibility Scale138 at the end of Session 
1. 
5.3: Concomitant Interventions  
5.3.1: Allowable Interventions  
Participating adolescents may continue to receive medical care from their primary care provider.   
5.3.2: Required Interventions 
Participants are expected to attend baseline visits, 8 weekly classes, and 6 continuation classes. In 
addition, they are encouraged to complete homework diaries (daily during the intervention, then weekly 
during the continuation sessions), weekly depression screens, and questionnaires at Visits 2, 6, 10, 13, 
and 16. 
Parent Measures 
Demographics  
 
Visit 2 
Short Mood and Feelings Questionnaire (SMFQ-P) 
Parent perception of adolescent’s 
depression 
Visit 2, Visit 6, Visit 10, Visit 13, Visit 16 

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5.3.3: Prohibited Interventions  
Participants will be excluded from enrolling in the program if they have participated in a mindfulness-
training program. They will be asked not to participate in any other mental health intervention study 
during their participation in this study, which includes a study on medications or other group 
interventions. Participants who do not develop major depression may follow the advice of their 
physicians and primary care providers and may take any prescribed medication. Participants who 
develop major depression during the study will be referred to a mental health provider. 
5.4: Adherence Assessment  
We will define study adherence as 80% compliance with the home practice and self-report assessments   
and attendance at 6 out of 8 weekly sessions and 4 out of 6 continuation sessions. 
6. STUDY PROCEDURES  
6.1: Schedule of Evaluations  
Participants will follow the schedule in Table 3 to complete consenting and assessments: 
Table 3. Schedule of Evaluations 
Assessment 
Visit 1 
Screen 
and 
Baseline 
Before 
Visit 2
(online)
Visit 2
(W0) 
Daily 
(W0-8)
Visits 
3-5 
(W1-3) 
Visit 6 
(W4) 
Visits 
7-9 
(W5-7) 
Visit 
10 
(W8) 
Visit 
11-12 
(W13, 
17) 
Visit 
13 
(W22) 
Visit 
14-15 
(W27, 
32) 
Visit 
16 
FINAL 
(W36) 
Informed Consent 
X
Demographics
X
Enrollment
X
Psychological 
X
Inclusion/Exclusio
X
Questionnaires
X
X
X
X
X
Randomization
X
Credibility 
X
Daily practice diary
X
Weekly practice 
X
X
X
X
Weekly depression 
X
X
X
X
X
X
X
X
X
Focus Group
X
X
Parent measures
X
X
X
X
6.2: Description of Evaluations 
6.2.1 Screening Evaluation 
Screening 
The screening process will consist of the following: 
 
Potentially eligible participants will be identified and referred to the study by guidance 

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counselors. Parents may also respond to study advertisements (e.g., UNC campus-wide email, 
posted flyers). 
 
Study staff will contact the candidate’s parents and, with permission, conduct an initial 
telephone screen with the adolescent. 
 
Information describing the study will be sent to the parent for sharing with the adolescent. 
 
Adolescents will be sent a link to the QIDS-SR assessment through REDCap. Study staff will 
review QIDS-SR scores. Participants with scores of at least 6 are considered eligible for a 
baseline psychological evaluation. 
 
A baseline psychological evaluation will occur within 5 weeks of screening. If the baseline 
psychological evaluation cannot be scheduled within this timeframe, the adolescent should 
retake the screening questionnaire to assure continued eligibility. 
 
After consenting, a parent and the adolescent will meet with the study psychologist for the 
baseline psychological evaluation using the in-person Diagnostic Interview Schedule for 
Children (DISC-IV), including assessment of eligibility criteria. 
 
The Study Psychologist notifies the study team of the adolescent’s eligibility for the class.  
Eligible participants will start the class within 6 weeks of the baseline visit. If the adolescent 
cannot start the class prior to the six weeks, the adolescent will participate in a review of 
eligibility criteria with the Study Psychologist. 
6.2.2: Enrollment, Baseline, and/or Randomization 
The enrollment procedures and baseline assessments will constitute Visit 1. 
Enrollment 
Study enrollment will occur at the time the parent signs the informed consent and the adolescent signs 
the assent form. Section 4.3.2 describes the consenting procedure. 
Baseline Assessments 
The adolescent and a parent participate in the baseline visit. At this visit, the adolescent and parent 
review the study consents and study procedures in detail with designated study personnel. If the parent 
signs the parental permission form and the adolescent signs the assent, they will see the Study 
Psychologist or a member of her staff that has been trained in administering the DISC-IV. The Study 
Psychologist will evaluate the adolescent’s eligibility for the program and notify study team personnel of 
eligibility. 
Randomization 
After the first two groups (one each of MFY and HLG),  randomization occurs one week before the first 
class. A designated study team member will use the randomization feature of REDCap to randomize 
participants. The procedure involves a review of eligibility followed by an assignment to one of the 
groups.  
6.2.3: Follow-up Visits 
Following the eight-week program, participants will have self-report assessments 22 weeks after the 
program (Visit 13) and 36 weeks after the program (Visit 16, final evaluation). 

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Visit 1 
Section 6.2.2, Enrollment and Baseline Assessments, provides a description of Visit 1.   
Visit 2 
Study staff will send the study questionnaires via a link to parents and adolescents one week before the 
start of classes. Parents and adolescents will complete the online measures. Once measures are 
completed, study staff will notify the participants of their group assignment and logistics of participation 
(time, place, etc.) 
Visits 3-10 (8 weeks of Classes) 
Adolescents attend the 8 weeks of classes. Classes will be audio recorded to evaluate the fidelity of the 
instructor to the program.   
Visit 6 (Week 4 of Classes) 
At week 4 of the intervention (Visit 6), adolescents complete a set of questionnaires online.  
Visit 10 (Week 8 of Classes) 
At week 8, adolescents participate in a focus group designed to obtain feedback about the 
program. The focus group will be audio recorded.   
In addition, adolescents complete another set of online questionnaires. Study staff will send a 
link to the study questionnaires to the adolescents and parent one week following completion 
of the 8-week class. See schedule of evaluations and list of measures above.  
Visits 11-16 (Continuation Classes—see 6.2.5 for final visit) 
At each continuation class, adolescents will review and practice what they learned in the 8-week classes.  
Both the adolescents and their parents will complete questionnaires 22 weeks post-intervention (Visit 
13) and 36 weeks post-intervention (Visit 16). At Visit 16, adolescents will participate in a brief post-
participation interview.  See schedule of evaluations and list of measures above. 
6.2.5: Completion/Final Evaluation 
At the end of the continuation phase, participants will complete the final on-line questionnaires.   
Early Discontinuation from Study Intervention 
Potential reasons for early termination include:  
1) Subject no longer interested 
2) Adverse events 
3) Subject not able or willing to follow the protocol 
4) Subject moved away from the area.   
If subjects withdraw early, the PI or a designee will follow-up by telephone to inquire about health 
status as it relates to adverse events experienced by the subject leading to early discontinuation of 
participation.  

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7. SAFETY ASSESSMENTS  
Participant safety is monitored through daily diaries (monitored by study staff), weekly depression 
assessments (PROMIS Pediatric Depression short form), and contact with program instructors (weekly 
during program, monthly during continuation phase). Participants exhibiting increased symptoms of 
depression are evaluated by the Study Psychologist and referred for further evaluation. Further details 
on safety are found in the study’s Data Safety Monitoring Plan (DSMP, Appendix IV). 
7.1: Specification of Safety Parameters 
Combined SMFQ-C / SMFQ-P scores of 12 is the recommended cut-off value for MDD; this value or 
greater will generate follow-up with the study psychologist. In addition, a T score of 70 or an increase 
of 3 standard deviations from the baseline score on the PROMIS depression measure will generate a 
referral to the study psychologist. 
7.2: Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
1) Timing: every contact with the participant will be an opportunity to capture adverse events.  
2) Recording: each incidence of an adverse event will be recorded in REDCap. 
3) Analyzing: the PI will be informed of all adverse events and will forward the information to the 
IRB and the Independent Safety Monitoring Committee (ISMC) (See DSMP). 
7.3: Adverse Events and Serious Adverse Events  
Adherence to current definitions and submission guidelines for identification and reporting to the IRB of 
Adverse Events (AEs), including Serious AEs (SAEs), and Unanticipated Problems (UPs) is planned. 
Reporting of all adverse events will be the responsibility of the PI (Dr. Susan Gaylord). The project 
manager and research assistant will assist the PI with summarizing, recording, and reporting all AEs. The 
PI will be informed of each AE by direct subject communication or by members of the research team. 
Subjects will be encouraged to report, in a timely fashion, any incidents of discomfort, or a change in 
health status for any reason, to the research personnel.  
It will be the responsibility of the PI, with assistance from the project manager and research assistant, to 
respond to IRB directives growing out of adverse events, including but not limited to, development and 
implementation of corrective action plans. The reporting process has recently been streamlined and 
made available online to investigators. It is also the responsibility of the PI to implement corrective 
action for SAEs, at times, in advance of IRB review of the incident.  
7.3.1: Definitions 
An adverse event (AE) is any untoward medical occurrence in a subject during participation in a clinical 
study or with use of the experimental agent being studied. An adverse finding can include a sign, 
symptom, abnormal assessment (laboratory test value, vital signs, electrocardiogram finding, etc.), or 
any combination of these regardless of relationship to participation in the study. 
A serious adverse event (SAE) is any AE that results in one or more of the following outcomes: 

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 
Death 
 
A life-threatening event 
 
Inpatient hospitalization or prolongation of existing hospitalization  
 
A persistent or significant disability/incapacity 
 
A congenital anomaly or birth defect 
 
An important medical event based upon appropriate medical judgment 
7.3.2: Classification of AE Severity 
Classification of AEs will be based on the Common Terminology Criteria for Adverse Events (CTCAE) 
Version 4, 2009. AEs will be described by symptom or condition/diagnosis, and graded for severity (mild, 
moderate, or severe) ― depending on the intensity of the event.  Two additional categories will be used 
based on the CTCAE system, “life threatening” and “death”.  
Grade 1.  Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; minimal impact 
on subject’s life; intervention not indicated.  
Grade 2. Moderate: medical care sought; significant but limited inconvenience on Activities of Daily 
Living (ADL) or lifestyle; local or noninvasive intervention indicated. 
Grade 3. Severe: medically significant but not immediately life-threatening; disabling; limiting self-care; 
substantial disruption to the subject’s well-being; hospitalization or prolongation of hospitalization 
indicated. 
Grade 4. SAE. Life-threatening consequences; urgent medical intervention indicated.  
Grade 5. SAE. Death: related to AE.  
An AE that is graded as severe (Grade 3) can be distinct from an SAE (Grades 4 and 5). A subject could 
experience a severe AE (Grade 3) that does not meet the definition of an SAE (see above). Alternatively, 
a subject could experience a moderate AE (fever, mild confusion) that meets the SAE definition 
(example - need for antibiotics to combat a life threatening infection).  
7.3.3: AE Attribution Scale  
AEs will also be classified on an assessment of relatedness to the study intervention. AEs will be 
categorized according to the likelihood that they are related to the study intervention. They will be 
labeled as: 1) definitely related, 2) definitely unrelated, 3) probably related, or 4) possibly related to the 
study intervention in the opinion of the PI and Study Psychologist after review of the circumstances and 
relevant records.  
7.4: Reporting Procedures 
No events will be solicited.  Unsolicited events will be captured by query at each subject contact after 
enrollment and through the diaries.  
A dated log of AEs, UPs, and SAEs will be kept in the study database. Data captured will include a 
detailed description of each incident, experience, or outcome.  In addition, staff will include an 
explanation of why the AE, incident, experience, or outcome is considered a UP.  The PI will determine 
and the project manager will document any changes to the protocol or corrective action taken or 

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proposed in response to a UP. 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported using the 
following timeline:   
 
Unanticipated problems that are serious adverse events will be reported to NCCIH within 7 days 
of the investigator becoming aware of the event.  
 
The PI, within 24 hours, will report all related or possibly-related AND serious adverse events 
(SAE) occurring in subjects to the IRB. This will be accomplished by submitting an adverse event 
report to the IRB and to the ISMC. Serious adverse events will be reported even if the PIs and 
Study Psychologist believe that the adverse events are unrelated to the protocol. 
 
 
Unexpected (but not serious) adverse events occurring in subjects which, in the opinion of the 
Study Psychologist, are possibly related to participation AND place subjects or others at a 
greater risk of harm than was previously known or recognized in the protocol will be reported by 
the PI within 24 hours of discovery by email or phone to the IRB and the ISMC. A follow-up 
written report within 5 business days to the IRB and the ISMC will be submitted by the PI. 
 
 
Unanticipated problems involving risks to subjects or others (UPIRTSOs) will be reported to the 
IRB and DSMB via email or telephone within 24 hours of discovery and a written follow up 
report within 5 business days. 
 
 
Any other unanticipated problem will be reported to the IRB, Independent Safety Monitor(s), 
and NCCIH within 14 days of the investigator becoming aware of the problem.  
 
 
When a protocol deviation occurs, the investigator will report the occurrence to the IRB. The 
investigator will make the determination whether the deviation meets the criteria for an 
unanticipated problem involving risks to subjects or others. The IRB Chair or IRB staff member 
will also make the determination if the protocol deviation meets the definition of an 
unanticipated problem involving risks to participants or others. 
 
All unanticipated problems will be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or designee), and OHRP within 
one month of the IRB’s receipt of the report of the problem from the investigator. 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be reported to 
the Independent Safety Monitor(s), IRB, and NCCIH in accordance with requirements.   
 
Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Office, and ISMC within 3 days of the investigator becoming aware of the 
event.  Other serious and unexpected AEs related to the intervention will be reported within 
7 days. 
 
Anticipated or unrelated SAEs will be handled in a less urgent manner but will be reported 
to the Independent Safety Monitor(s), IRB, and other oversight organizations in accordance 
with their requirements and will be reported to NCCIH on an annual basis.    

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 
All other AEs documented during the course of the trial will be reported to NCCIH on an 
annual basis by way of inclusion in the annual report and in the annual AE summary which 
will be provided to NCCIH and to the Independent Monitors.  The Independent Safety 
Monitor(s) Report will state that all AEs have been reviewed. 
 
All AEs documented during the course of the trial will be reviewed by the Independent 
Safety Monitoring Committee (ISMC) on a regular basis.  The ISMC will meet initially after 
the first cohort (20) subjects have completed the intervention and are in the continuation 
phase of the study.  The ISMC will meet every 36 weeks thereafter. 
Detection of increased depression.  
A major activity of the Board will be to determine if subjects are developing depression at an unusual 
rate during their time in the project.  Removal of subjects from the study is included in the 
responsibilities of the PI.  Study continuation is the duty of the ISMC and rests, in part, on the collected 
data pertaining to incidence of new depression in this subject population.   
7.5: Follow-up for Adverse Events 
The Study Psychologist will investigate AEs related to participant mental health and make appropriate 
referrals for further care. The Study Psychologist will follow-up with the parent to assess follow-through 
within one week of the reported event. The Project Manager will investigate all other AEs and follow up 
with the participant until stable. 
7.6: Safety Monitoring (See DSMP) 
An Independent Safety Monitoring Committee (ISMC) will be constituted with a charter describing 
membership, meeting frequency, review process, report generation, liaison with the PI and research 
team, range of recommendations and criteria for subject removal and program suspension.  
ISMC membership should include: a psychologist with expertise in depression, a 
psychologist/psychiatrist with a research/statistical background, and an individual with expertise in 
mindfulness.  None of these individuals will be directly associated with the study other than through the 
ISMC.  
7.6.1: Frequency of Review   
The ISMC will meet prior to the first group trainings, and within one month after the first full cohort of 
20 subjects (10 in each group) have completed the 8 week training period. They will meet every six 
months thereafter or whenever the PI requests a review outside of those times. Meetings will be 
facilitated by the PI and project manager by providing a private meeting location and all requested 
materials on the day of the review. The PI and project manager will also provide a summary of the 
project dating from the time of the last review. The PI and other research personnel will be available to 
meet with the Board as requested. The ISMC will continue to meet through data collection. 
7.6.2: Review Materials  
The ISMC will review all available data sets, AEs, SAEs and UPs, operational manuals, focus group 
reports, IRB submissions and renewal documentation, IRB notifications and all other materials 
generated by the study.  

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7.6.3: Summary report   
A member of the ISMC will be designated by consensus as chairperson and will be responsible for 
conducting the meetings and for preparing a report after each meeting, summarizing the review along 
with recommendations for changes, if any, and continuation of the project. The report will be 
transmitted to the PI within 2 weeks of the meeting unless there is urgency, as determined by the 
Board, requiring action.   
8. INTERVENTION DISCONTINUATION  
8.1:  Discontinuation of Intervention for a Participant 
Subject may stop their participation for any reason, e.g., the subject is non-compliant with the protocol; 
subject develops unacceptable side effects; or psychosocial circumstances prevent continuation.    
8.2: Possible reasons for discontinuation of the whole study   
Possible reasons for discontinuation of the whole study include the following:   
 
Study closure by NIH institute 
 
Research environment is no longer supportive 
 
Multiple Unexpected Problems (UP) 
 
Insufficient recruitment 
 
ISMC or Study Monitor find evidence of serious safety issues. If greater than 3 enrolled and 
randomized subjects develop a grade 3 or greater adverse event due to the intervention, the 
entire study would be stopped and the ISMC will reevaluate. 
8.3: Early discontinuation  
Participants will continue to be followed, with their permission, for another 6 weeks if study 
interventions are discontinued for reasons other than the normal end of the study. Permission will be 
sought for questionnaire completion at stopping.    
8.4: Normal end to the study  
At the end of the 8-week intervention, subjects completing that part of the study will be followed for 
another 36 weeks with encouragement to maintain their assigned home practice. Questionnaires will be 
completed at 22 weeks post-intervention (Visit 13) and 36 weeks post intervention (Visit 16). 
9. STATISTICAL CONSIDERATIONS  
9.1: General Design Issues  
This study is a planning grant for development of an adequately powered clinical trial. Statistical 
hypotheses are not considered relevant to this mechanism. Randomization is designed to assess 
feasibility of our randomization plan, in addition to general feasibility issues of the delivery of the 
educational programs. 

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In our third aim, we proposed exploratory analysis of clinical outcomes (see below). 
9.2: Sample Size and Randomization 
9.2.1: Treatment Assignment Procedures 
Participants are randomized to treatment assignments to test the acceptability of randomization in the 
population. Random allocation, stratified by gender, is assured by a computer-generated assignment 
accessible to the REDCap administrator, but group assignment cannot be masked, except to quantitative 
data analysts.   
Power and sample size. Untreated, >30% of adolescents are expected to develop incident depression. 
Power is calculated for time to incident MDD. With a sample size of 80, we expect to have 80% power to 
detect a hazard ratio of 0.52 for time to MDD between the groups. It is anticipated that we will screen 
160 with the QIDS and 120 with the DISC to achieve a sample of 80 eligible teens (with 80 parents). Our 
target recruitment estimate is 53 females and 27 males, based on research demonstrating that there are 
twice as many female teens with subsyndromal depression as males. Note that all enrollment figures 
refer to teens. Each will have the involvement of one parent. 
9.3: Definition of Populations 
The ITT (Intent to treat) population is any participant randomized to an intervention group, whether or 
not he/she participates. “Per protocol” populations (“Completers”) are participants who do not formally 
withdraw. 
9.4: Interim Analyses and Stopping Rules 
9.4.1: Study-wide stopping rules 
These include the occurrence of a serious adverse event, CTCAE Grade 3 or higher, possibly related to 
the study protocol, occurring in 5 or more randomized adolescents. If these conditions occur, the ISMC 
will review and make recommendations on the advisability of continuing the study 
9.4.2: Individual stopping rules   
If a participant scores above 12 on the combined parent and child SMFQ at any point in the study, s/he 
will be referred to the study psychologist (Dr. Harris-Britt) within 24 hours. The study psychologist will 
then contact the parent of the teen (within 24 hours) to inform the parent of the depression status of 
the teen. Dr. Harris-Britt will make an evaluation to determine if s/he can continue in the study and will 
refer the family for appropriate psychological care. 
We have added a safety depression screening measure, the PROMIS pediatric depression scale, which 
will be administered weekly via REDCap. The Assessment Center at NIH provides a scoring algorithm 
with REDCap software, enabling use of the measure for safety monitoring. The Project Manager or 
trained designee will monitor these measures weekly and will alert the team (including the Study 
Psychologist) to sharp increases in depressive symptoms and depressive symptoms meeting criteria for 
major depression. If the Study Psychologist confirms the development of major depression, the 
adolescent will be withdrawn from the study and referred for further care. 

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9.4.3: Additional Reasons for Withdrawal of a Participant  
Additional reasons a participant may withdraw from the study include: 
 
The adolescent wishes to withdraw from the study; 
 
Loss of study eligibility (development of major depression); 
 
Intervening illness or injury making participation difficult; 
 
The adolescent develops any condition that, in the opinion of the study psychologist, would 
make continued participation unsafe. 
In the unlikely event that a participant is unable to participate in a group setting, s/he may be withdrawn 
from the study. 
9.5: Outcomes  
Our primary goal is to develop a depression-prevention program based on mindfulness and self-
compassion and to establish the feasibility of its implementation as compared with an active attention-
control comparator. Hence, the establishment of quality assurance processes and complete data 
documentation assume even greater importance than data analysis. Data of multiple types from 
multiple sources will be captured. For questionnaire assessments, secure internet-based data collection 
instruments will be used, accessible by internet-capable device.  
Quality assurance of these measures will include review of study instruments for range and consistency 
checks, and descriptive analyses to assess distributions of study variables. Quality assurance of 
qualitative measures include 1) maintaining a spreadsheet to log scheduled, completed, transcribed, and 
analyzed focus groups and interviews; 2) establishing a transcription template to ensure data is uniform 
in appearance; 3) arranging for secure storage of recordings and transcripts on REDCap; 4) review of 
consistency of styles across interviewers; and 5) review of recordings to assess accuracy of 
transcriptions.  
All statistical analyses will utilize all adolescents who were randomized to one of the intervention arms 
and who attended at least one class.  Individuals who were unable to attend a class are excluded.  
Complete case analyses are planned (without imputations).   
9.5.1: Primary Outcome   
For the primary outcome, (to be explored as described in Specific Aim 3, once feasibility is examined in 
Specific Aim 2), a score of 70 on the PROMIS Pediatric Depression Scale short form t-score. To assess 
incident depression, we will use exploratory nonparametric (Kaplan-Meier plots) and semi-parametric 
analyses (Cox proportional hazards models) to examine the trends in incident depression within and 
between treatment arms.  If too few students reach the target of 70 (2 standard deviations above the 
population mean), we will explore outcomes using a target of 65 (1.5 standard deviations above the 
population mean).  We had originally planned to use the SMFQ, but the SMFQ was collected only 5 
times for those with complete data and the PROMIS Depression score was collected weekly, making it a 
much more reasonable measure for a time-to-event analysis. 
9.5.2: Secondary Outcomes   
For the secondary outcome, assuming feasibility is established, change in the Short Mood and Feelings 
Questionnaire (child and parent versions) will be examined in a linear regression in each condition, to 
test for any effect of either program. Then we will examine the change in depression scores through an 

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ANCOVA model controlling for baseline depression score and cohort to control for group specific effects. 
Subsequently, an exploratory analysis will examine the trajectory of changes over time by program arm, 
using graphical representations of outcomes at each time point by subject, cohort, and program arm as 
well as a longitudinal random effects model. 
Hence, a within-group model would include terms for the follow-up depression score, the overall 
intercept, the cohort effect, the time effect, and a cohort*time interaction—to allow the trajectory to 
vary by cohort—as well as random effects for individual subjects and subjects nested within cohorts. 
Between program arms, we would add terms for the program arm and its interaction with time. 
9.6: Data Analyses  
9.6.1 Exploratory analyses of outcomes and mediators.  
Exploratory analyses will involve first examining variable distributions and missing data patterns. Next, 
we will conduct exploratory analyses to assess patterns of change associated with participation in the 
programs. The study is not expected to produce a quantity of data large enough to have adequate 
power to detect significant effects of the MFY program compared to the TFY control program.  However, 
trends in incident depression (primary outcome, PROMIS Pediatric Depression Scale), change in 
depression scores (combined SMFQ-C, PROMIS Pediatric Depression Score) resilience (secondary 
outcome), and potential mediators will be examined by program arm. 
To assess incident depression, we will use exploratory nonparametric (Kaplan-Meier plots) to examine 
the trends in incident depression within and between treatment arms using the PROMIS Pediatric 
Depression Scale short-form..   
To address the change in depressive symptoms (secondary outcome), we will examine the paired t-test 
in each condition, to test for any effect of either program.  Subsequently, an exploratory analysis will 
examine the trajectory of changes over time by program arm, using graphical representations of 
outcomes at each time point by subject, cohort, and program arm as well as longitudinal random effects 
models. Hence, a within-group model would include terms for the follow-up depression score, the 
overall intercept, the cohort effect, the time effect, and a cohort*time interaction—to allow the 
trajectory to vary by cohort—as well as random effects for individual subjects and subjects nested 
within cohorts.  
Additional explorations will include bivariable associations (correlation, simple regressions) between the 
process measures and the outcome, between intervention assignment and process measures, between 
intervention assignment and potential mediators, and between process measures and outcomes. If 
indicated, mediation analyses will be conducted to investigate possible mechanisms; strength of 
mediation (indirect effect) will be calculated as the product of the association of the causal variable on 
the mediator and the association of the mediator on the outcome variable.      
9.6.2:  Feasibility Analyses 
Feasibility will be measured by the following:   
1. Acceptance of the treatment and control programs as measured by attendance in 6 of 8 active 
intervention sessions and 4 of 6 continuation sessions;  
2. Equivalence of the credibility of the two programs as measured with the credibility 
questionnaire;  

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3. Identification of recruitment challenges and their remedies as measured by:  
a. the number of individuals screened;  
b. the proportion of screened adolescents who qualify;  
c. the number of qualifiers who enroll; and d) the number of enrollees who complete the 
program—80% completion defined by the acceptance criteria above defines a feasible 
program;  
4. Identification of factors associated with subjects’ willingness to adhere to the study protocol 
such as:  
a. Location or timing of program classes, or lack of transportation;  
b. Those not completing the program will be contacted for a telephone interview to 
evaluate factors leading to dropout.  
5. Identification of study components fostering engagement in the study groups and materials. 
Subject Engagement 
In addition to attendance data, engagement will be measured by: 
1. Subjective class participation as rated by the instructor;  
2. Adherence to recommended homework practice as measured in the daily diary; 
3. Barriers for practice as captured in the diary; 
4. Participant comments about the degree to which these practices have enabled them to 
adopt an attitude of mindfulness and self-compassion (as captured in the audio-taped 
class sessions). At the end of participation in the study, at month 8-9, subjects will be 
invited to give their impressions about the study in a brief, post-participation focus 
group or interview (see Section 5.1.3, Qualitative Measures).  
Program Fidelity 
All program sessions will be audio-recorded. The purpose of the recording is two-fold: 
1. To identify any systematic variations in instructors’ attitude, communication, or 
behavior between treatment groups; to assess adherence to the protocol; and to screen 
for any group-dependent differences in communication in content or style between the 
instructors and subjects; 
2. To capture participants’ input and comments during the classes (see qualitative 
analysis).  
An evaluation matrix will be developed based on the program manuals and other written protocols.  
Two members of the study staff will listen to selected program sessions independently to rate 
adherence to the protocol.   
Program Credibility 
Credibility is measured by both the Borkovec and Nau questionnaire and qualitative data.   
 
Acceptance of randomization is measured by a comparison of drop-out rates by intervention arm. 

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10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1: Data Collection: Data Type, Personnel Collecting Data 
Project Manager and Research assistants:   
 
Entering screening data.   
 
Prompting questionnaire completion by both parents and teens.   
 
Reminding teens to complete daily/weekly homework assignment assessments and 
depression screens.  
The study psychologist or a member of her practice will collect eligibility data. 
10.2: Data Management  
Data resulting from telephone screening is housed in a screening database on REDCap. The research 
assistant will enter screening data directly into REDCap.  
After consenting, the participant is added to the study REDCap database as an enrolled subject. The 
study psychologist will notify study staff if the participant remains eligible for the study after evaluation.  
This information will be added to the study database as eligible or ineligible at baseline (to protect 
participant privacy).   
Online data collection forms are developed by the PIs and the Project Manager. Participants and their 
parents enter this questionnaire data directly into REDCap. 
10.3: Quality Assurance  
10.3.1: Training 
Current HIPAA and CITI training (Human Research Ethics, Good Clinical Practice) certificates are required 
of all study personnel who will be recruiting subjects, evaluating subjects, collecting or analyzing data. 
Before participant data is collected, the PI or Project Manager will ensure that staff has completed 
training for applicable tasks. A log including dates and type of training will be kept in section 10 of the 
Study Regulatory Binder. 
The Study Manual of Operating Procedures (MOP) will include detailed procedures for each of the 
following: 
 
Consent forms: 
o Telephone/screening (with detailed script and instructions included) 
o Full Consent (parental permissions and assents)  
o HIPAA Consent 
o Social Security Collection for Payments 
 
Study visit procedures including advising participants in collection of questionnaire and diary 
data 

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 
Advising participants on use of the study app 
10.3.2: Quality Control Committee  
The quality control committee consists of the project manager, the internal QA Reviewer (Faurot), and 
the study statistician (Suchindran). Monthly reports are made to the committee and PI by the project 
manager.   
10.3.3: Metrics 
Diary Data  
Participants will complete daily diaries during the 8 weeks of classes. The adolescents will receive a text 
prompt from the study team if they have not completed their diaries by 4:00 PM. 
Self-report Questionnaires   
Questionnaires will be completed at baseline (Visit 2) and at weeks 4 (Visit 6), 8 (Visit 10), 22 (about 22 
weeks after the intervention; Visit 13), and 36 (about 36 weeks after the intervention ends; Visit 16). 
Participants will complete the questionnaires via a link to the survey mechanism on REDCap, accessing 
the site through a password-protected interface. The questionnaires prompt participants to complete 
skipped items and they must confirm that they wish to skip an item.  After the participant completes the 
questionnaire, study team personnel will access the REDCap site and check the entries for completeness 
to ascertain any computer or questionnaire malfunction. Study team will keep paper copies of the 
questionnaires for use in the event of site malfunction.   
Questionnaires designed to be completed on paper (Expectation of Benefit/Credibility), will be made 
available to participants at the first class, collected by the research assistant, and entered (twice) into 
REDCap. The paper copy will be saved in the participant’s study folder to be used for corrections as 
needed.  An error rate of greater than 1% will generate additional training. 
10.3.4: Protocol Deviations 
Staff will be trained to record any protocol deviation that may occur while performing their specific 
research related activities. Many of the data collection forms include comment sections where protocol 
deviation information will be captured on the source documents. Deviations will also be documented in 
the Study Regulatory Binder, section 12, and on REDCap. Training of the research staff will include 
practices of double checking all demographics, inclusion/exclusion criteria, data collection procedures 
including capture and secure storage, intervention procedures and data management activities.   
Deviations will be documented as a written report submitted to the UNC IRB by the PI or Project 
Manager. New deviations will be presented by the Project Manager at the monthly Project Team 
meeting and reviewed by the research team at that time. Corrective action plans will be developed and 
submitted to the IRB as part of that reporting process.  
10.3.5: Monitoring 
The PI and Project Manager are responsible for scheduling any clinical site monitoring visits at the 
direction of NCCIH. The logs and reports of these visits are kept in the Study Regulatory Binder. 

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11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1: Institutional Review Board (IRB) Review  
This protocol and the informed consent document (Appendix I) and any subsequent modifications will 
be reviewed and approved by the UNC IRB responsible for oversight of the study. The IRB application, 
modification and renewal procedures will be adhered to throughout the study.  
11.2: Informed Consent Forms 
A signed parental informed consent form and a signed participant assent form will be obtained for each 
participant if the teen participant is under 18, and a consent form from the teen participant if the 
participant turns 18. 
The consent form will describe the purpose of the study, the procedures to be followed, reasons not to 
be in the study, the risks and benefits of participation, responsibilities of the participant, incentives and 
remunerations, privacy and confidentiality measures, and the name and contact information for the PI 
and the study staff. The participant will be given the opportunity to read the Informed Consent and ask 
questions regarding the study. If they have their questions answered and are willing to participate, the 
informed consent and informed assent will be signed at this meeting and also signed by the study staff 
that is obtaining the consent. A copy of the IFC and the IFA will be given to each participant. 
11.3: Participant Confidentiality  
Participant confidentiality will be maintained according to the Health Insurance Portability and 
Accountability Act (HIPAA). All records will be kept in a locked file cabinet. All data will be stored on 
password-protected computers in an encrypted database. 
11.4: Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected.  
12. COMMITTEES 
An Independent Safety Monitoring Committee (ISMC) will be formed. Refer to Section 7.6: Safety 
Monitoring and Appendix IV for details about the ISMC. 
13. PUBLICATION OF RESEARCH FINDINGS 
Research findings will be published in ClinicalTrials.gov and in the scientific literature.  A poster 
documenting the development of the Healthy Lifestyles Group has already been presented at the 
American Public Health Association Meeting in 2019. 
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Appendices 
A. Informed Consent Forms (Telephone consent, Parental Consent, Child Assent, Adult Consent) 
a. Telephone Consent 
b. Parental Consent 
c. Child Assent (ages 14-17) 
d. Adult Consent (age 18) 
B. Measures  
a. Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) 
b. Diagnostic Interview Schedule for Children- Version IV (DISC-IV) 
c. Adolescent Survey 
i. Short Mood and Feelings Questionnaire (SMFQ-C) 
ii. Brief Resiliency Scale (BRS) 
iii. Adolescent Cognitive Style Questionnaire (ACSQ) 
iv. Ruminative Response Style scale – brooding factor (RRS-B) 
v. Test for Self-Conscious Affect for Adolescents (TOSCA-A) 
vi. Self-Compassion Scale (SCS)  
vii. Child and Adolescent Mindfulness Measure (CAMM) 
viii. Demographics  
d. Parent Survey 
i. Short Mood and Feelings Questionnaire (SMFQ-P) 
ii. Demographics 
e. PROMIS Pediatric Short Form (version 1.1) 
f. 
Expectation of Benefit / Credibility 
g. Daily Diary 
C. Recruitment Materials 
a. Flyer 
b. Email Announcement 
D. 
Data Safety Monitoring Plan (without Appendices) 
 
 
 

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Appendix A.a: Telephone Consent (version 0.3, 7 June 2017) 
 
 
 

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Appendix B.a: QIDS-SR 
    
 
 

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Appendix B.b: Diagnostic Interview Schedule for Children- Version IV (DISC-IV) 
Only the Depression Section of DISC-IV shown. 
 
 
 

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Short Mood and Feelings Questionnaire (SMFQ-C) 
 
 
 

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Test for Self-Conscious Affect for Adolescents (TOSCA-A) 
 
 
 

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Child and Adolescent Mindfulness Measure (CAMM) 
 
 

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Adolescent Demographic Questions 
  
 
 

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Appendix B.d: Parent Survey 
Short Mood and Feelings Questionnaire (SMFQ-P) 

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Parent Demographics Questions 
  
 
 

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Appendix B.e: PROMIS Pediatric Short Form (version 1.1) 
Weekly measure for participants during 8-week intervention 
 

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Appendix B.f: Expectation of Benefit / Credibility 
 

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Appendix B.g: Daily Diary 
 
 

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Appendix IC: Recruitment 
Flyer 
 
 
 
 

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Email Announcement 
 
 
 

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Appendix IV: Data Safety Monitoring Plan (version 0.3, 23 May 2017) 
Appendices of Data Safety Monitoring Plan (DSMP) not included. The DSMP appendices include CVs for 
ISMC members, which goes from page 17-148 of the DSMP. 

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