Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths
Phase: NA
Conditions: Depression
Sponsor: Stony Brook University

Study Protocol and Analytic Plan 
 
Date: December 27, 2019 
 
Title: Promoting Treatment Access Following Pediatric Primary Care Depression Screening 
 
NCT04030897 
 
PI: Jessica Schleider, PhD 
Jessica.schleider@stonybrook.edu  

RUNNING HEAD: SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE  
  
  
  
   
  
Promoting treatment access following pediatric primary care depression screening: Randomized trial of  
 
web-based, single-session interventions for parents and youths 
  
 
Jessica L. Schleider, Ph.D.a *  
 
Mallory Dobias, B.S. a 
 
Susmita Pati, M.D., M.P.H. b  
  
*Corresponding author and primary contact for public and scientific inquiries related to this manuscript. 
Tel: 631 632 4131; jessica.schleider@stonybrook.edu; Stony Brook University, Stony Brook, NY, USA, 
11794-2500 
a  Department of Psychology, Stony Brook University 
b Division of Pediatric Primary Care, Stony Brook University 
 
CITATION:  
 
Schleider, J.L., Dobias, M.L., & Pati, S (2020, in-principle acceptance, Stage 1 Registered Report). 
Promoting treatment access following pediatric primary care depression screening: Randomized trial of 
web-based, single-session interventions for parents and youths. Journal of the American Academy of 
Child and Adolescent Psychiatry.  
 
 
Funding. This study is supported by a 2019 Access to Care Grant from the Klingenstein Third 
Generation Foundation, awarded to Dr. Schleider (PI) and Dr. Pati (Co-I). The funding source had no role 
in the design and conduct of the study; preparation, review, or approval of the manuscript; or the decision 
to submit the manuscript for publication. There are no additional funding sources for this work.  
Disclosures. Separate from this work, Dr. Schleider has received grant and research support unrelated to 
this study from the American Psychological Foundation, the Klingenstein Third Generation Foundation, 
the Center on the Developing Child at Harvard University, Limbix Health, Inc., and the National 
Institutes of Health. Dr. Schleider and Ms. Dobias are under contract with New Harbinger Publications to 
co-author a therapy workbook for adolescents. Ms. Dobias receives research support from a Stony Brook 
University Graduate Council Fellowship. Dr. Pati has received grant and research funding unrelated to 
this study from the National Institute of Health, HRSA, Agency for Healthcare Research and Quality, 
Centers for Disease Control, Slomo and Cindy Silvian Foundation, New York State Office for People 
with Developmental Disabilities, New York State Department of Health. The Commonwealth of 
Pennsylvania, Department of Public Welfare, American Lung Association, Robert Wood Johnson 
Foundation. Anne E. Dyson Foundation, David E. Rogers Foundation, Arnold P. Gold Foundation, and 
The Pew Charitable Trusts. The authors report no additional financial conflicts. 

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Promoting treatment access following pediatric primary care depression screening: 
Randomized trial of web-based, single-session interventions for parents and youths 
Stage 1 Registered Report  
 
Study Synopsis 
Introduction Summary. Major depression in youth is a serious psychiatric illness with extensive 
acute and chronic morbidity and mortality.1 In 2018, the American Academy of Pediatrics released 
updated practice guidelines promoting screening of youth depression in primary care (PC) clinics across 
the country, representing a critical step towards increasing early depression detection.2 However, the 
challenge of bridging screening with service access remains. Even when diagnosed by PC providers, 
<50% of youth with elevated depressive symptoms access treatment of any kind.2 Thus, there is a need 
for interventions that are more feasible for youths and parents to access and complete—and that may 
strengthen parents’ likelihood of pursuing future, longer-term services for their child. 
Single-session interventions (SSIs) may offer a promising path toward these goals. SSIs include 
core elements of comprehensive, evidence-based treatments, but their brevity makes them easier to 
disseminate beyond traditional clinical settings.3 Indeed, SSIs can successfully treat youth 
psychopathology: In a meta-analysis of 50 randomized controlled trials, SSIs reduced youth mental health 
difficulties of multiple types (mean g=0.32).3  To date, one SSI has been shown to reduce youth 
depressive symptoms in multiple RCTs: the online “growth mindset” (GM) SSI, which teaches the belief 
that personal traits are malleable rather than fixed.4–8 As one example, a 30-minute GM-SSI led to 
significant 9-month MD symptom reductions in high-symptom youths ages 12-15 versus a supportive 
therapy control (N=96; ds=0.60, 0.32 per parent and youth reports).6 Thus, GM SSIs represents a scalable, 
evidence-based strategy for reducing youth depressive symptoms. 
GM-SSIs can also strengthen parent beliefs about the effectiveness of mental health treatment, 
which robustly predict whether youths ultimately access services.9 A recent RCT including 430 parents of 
youth ages 7-17 indicated that an online, 15-minute SSI teaching growth mindset of emotion (viewing 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
          3 
emotions as malleable) significantly increased parents’ beliefs that psychotherapy could be effective, both 
for themselves (d=0.51) and their offspring (d=0.43), versus a psychoeducation control.6 By helping 
reverse parents’ low expectancies for treatment, this low-cost program may enhance parents’ odds of 
seeking services for children with mental health needs. 
Accordingly, this study will test whether empirically-supported GM-SSIs can help bridge the gap 
between PC-based depression screening and access to depression services for high-symptom youth. 
Youths reporting elevated internalizing symptoms at a PC visit will be randomly assigned to one of two 
conditions: Information, Psychoeducation, and Referral (IPR; i.e., usual care) or IPR enhanced with 
youth- and parent-directed online SSIs (IPR+SSI), designed to reduce youth internalizing symptoms and 
improve parents’ mental health treatment expectancies, respectively. We predict that (1) IPR+SSI will 
increase parents’ treatment-seeking behaviors, versus IPR alone, across 3-month follow-up; (2) IPR+SSI 
will reduce youth depressive symptoms across 3-month follow-up versus IPR alone; (3) IPR+SSI will 
reduce parental stress and psychological distress across 3-month follow-up, versus IPR alone; (4) parents 
and youths will rate this service delivery model as acceptable. 
Method Summary (see Figure 1). Per youth-reported internalizing symptom elevations during a 
PC visit (score >5 on the Pediatric Symptom Checklist internalizing subscale), eligible families (N=246; 
youth ages 11-16) will be invited to participate in the study. In online surveys, parents will self-report 
recent treatment-seeking behaviors, expectancies for psychotherapy, stress and psychological symptoms, 
and youth mental health problems, along with family and demographic information; youths will self-
report symptom levels. Within the same survey, youths and parents will then be randomized (1:1 
allocation ratio) to one of two experimental conditions (IPR+SSI or IPR alone); those assigned to 
IPR+SSI will complete an intervention feedback form immediately post-intervention. At 3-month follow-
up, to assess SSI effects on parent treatment-seeking, parent stress and symptoms, and youth depressive 
symptoms, participating youths and parents will complete the same questionnaires administered at 
baseline. 

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Significance. There is a need for novel, potent strategies to increase families’ access to youth 
mental health services following PC-based symptoms screening. Ideally, such strategies would be low-
cost (e.g., those that do not require new staff); involve both parents and youths to address the myriad 
factors that may undermine service access; and impose minimal burdens on PC providers. Results will 
indicate whether one such strategy—providing online, low-cost SSIs to youths and parents—may help 
reduce youth depressive symptoms and promote treatment-seeking in parents.  
Clinicaltrials.gov registration: NCT04030897 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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References 
1.  Whiteford HA, Degenhardt L, Rehm J, et al. Global burden of disease attributable to mental and 
substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 
2013;382(9904):1575-1586. 
2.  Zuckerbrot RA, Cheung A, Jensen PS, Stein REK, Laraque D, GLAD-PC STEERING GROUP. 
Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part I. Practice Preparation, 
Identification, Assessment, and Initial Management. Pediatrics. 2018;141(3). 
doi:10.1542/peds.2017-4081 
3.  Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session 
Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017;56(2):107-
115. 
4.  Miu AS, Yeager DS. Preventing Symptoms of Depression by Teaching Adolescents That People 
Can Change. Clinical Psychological Science. 2015;3(5):726-743. doi:10.1177/2167702614548317 
5.  Schleider JL, Weisz JR. Reducing risk for anxiety and depression in adolescents: Effects of a 
single-session intervention teaching that personality can change. Behav Res Ther. 2016;87:170-181. 
6.  Schleider JL, Weisz JR. Parent Expectancies and Preferences for Mental Health Treatment: The 
Roles of Emotion Mind-Sets and Views of Failure. J Clin Child Adolesc Psychol. 
2018;47(sup1):S480-S496. 
7.  Schleider JL, Burnette JL, Widman L, Hoyt C, Prinstein MJ. Randomized Trial of a Single-
Session Growth Mind-Set Intervention for Rural Adolescents’ Internalizing and Externalizing 
Problems. J Clin Child Adolesc Psychol. June 2019:1-13. 
8.  Schleider J, Weisz J. A single-session growth mindset intervention for adolescent anxiety and 
depression: 9-month outcomes of a randomized trial. J Child Psychol Psychiatry. 2018;59(2):160-
170. 
9.  Nock MK, Kazdin AE. Randomized controlled trial of a brief intervention for increasing 
participation in parent management training. J Consult Clin Psychol. 2005;73(5):872-879. 
 
 

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Promoting treatment access following pediatric primary care depression screening: Randomized 
trial of web-based, single-session interventions for parents and youths 
Psychiatric disorders are the leading cause of disability worldwide, and 40.5% of this burden is 
attributable to major depression.1  Depression symptoms and disorders increase markedly in adolescence, 
with nearly 20% of youth experiencing depression between ages 11 and 18.2  Despite this early onset and 
protracted course, up to 70% of U.S. youth with depression never receive services.2,3 To improve 
identification of youths in need of services, the American Academy of Pediatrics released practice 
guidelines promoting depression screening in primary care (PC) clinics.4 However, even when identified 
by PC providers and offered community referrals, <50% of youth with depressive symptoms access 
treatment.4 Thus, there is a need for interventions that are feasible for families to access and complete; 
can be offered via PC clinics efficiently and cost-effectively; and that encourage parents to seek out 
services for offspring in the future. 
Single-session interventions (SSIs) may forward these goals. SSIs include core elements of 
comprehensive evidence-based treatments, but their brevity makes them easier to disseminate.5,6 Indeed, 
SSIs can successfully treat youth psychopathology: In a meta-analysis of 50 RCTs, SSIs reduced youth 
psychiatric difficulties of multiple types (mean g=0.32), including web-based SSIs (mean g=0.32).5 To 
date, one SSI has reduced youth depressive symptoms across multiple trials: the growth mindset (GM)-
SSI, which teaches the belief that traits and attributes—such as sadness, shyness, and loneliness—are 
malleable rather than fixed.7–9 A web-based, 30-minute GM-SSI has led to significant 9-month depressive 
symptom reductions in high-symptom youth ages 12-15, versus a supportive-therapy SSI (N=96; ds=0.60, 
0.32 per parent and youth reports, respectively).10 Separately, a GM-SSI significantly reduced depressive 
symptoms across 4 months in adolescent girls (N=222; d=0.23), versus an active control.9 Thus, the GM-
SSI may be a scalable, promising strategy for reducing youth depressive symptoms. 
GM-SSIs may also strengthen parent beliefs about the effectiveness of mental health treatment, 
which robustly predict whether youths ultimately access and benefit from services.11  In a RCT of 430 
parents of youth ages 7-17, an online, 15-minute SSI teaching growth emotion mindset (viewing emotions 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
          7 
as malleable) significantly increased parents’ beliefs that psychotherapy could benefit themselves 
(d=0.51) and their children (d=0.43) versus a psychoeducation control.12  This low-cost, self-administered 
program may improve parents’ treatment expectancies, potentially improving their likelihood of seeking 
support for their children’s mental health needs.  
Present study. We will examine whether these online GM-SSIs can bridge the gap between PC-
based depression screening and service access for high-symptom youth. Youths ages 11-16 (N=246) 
reporting elevated internalizing symptoms at a PC visit will receive either Information, Psychoeducation, 
and Referral (IPR; usual care) or IPR enhanced with youth- and parent-directed online GM-SSIs 
(IPR+SSI), designed to reduce youth depressive symptoms and improve parents’ expectancies of mental 
health treatment, respectively. Our primary hypotheses are two-fold. We predict that (1) IPR+SSI will 
increase parents’ treatment-seeking behaviors, versus IPR alone, across 3-month follow-up; and we 
predict that (2) IPR+SSI will reduce youth internalizing symptoms across 3-month follow-up versus IPR 
alone. Hypotheses (1) and (2) are co-primary outcomes; both will help gauge whether GM-SSIs improve 
access to effective treatment, either as stand-alone interventions or by promoting increased service-
seeking.  
We expect that these co-primary hypotheses may relate to one another in at least two ways, 
although we do not have specific predictions as to how this interrelation may manifest (see Figure 2). 
First, the SSIs’ effects on parent treatment-seeking and youth internalizing symptoms may relate inversely 
to one another, due to differential intervention effects on each outcomes. That is, the SSIs might 
positively influence youth problems or parent treatment-seeking, depending on which effects are more 
rapidly apparent to the family. For instance, if effects on youth internalizing symptoms emerge more 
rapidly and overtly than effects on parent treatment-seeking, parents may in turn be less inclined to seek 
additional care.  Likewise, if effects on youth symptoms fail to emerge within a short period of time, 
parents may be more inclined to seek additional care after completing the parent-directed SSI. Thus, is it 
possible that effects may emerge for either parent treatment-seeking or youth symptoms, but not both. 
Conversely, it is possible that the SSIs may positively affect parent treatment-seeking and youth 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
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internalizing symptoms simultaneously. If parents perceive initial symptom reductions in their child 
following the SSI, these initial improvements—indicating the potential for further gains—may further 
motivate them to seek additional care. We perceive both pattern of results as equally plausible in the 
present trial; either would help clarify the potential role(s) of these SSIs within pediatric primary care. 
In addition to our co-primary hypotheses, we will also test two secondary hypotheses to further 
contextualize the intervention’s effects and acceptability. We predict that (3) IPR+SSI will reduce 
parental stress and psychological distress across 3-month follow-up, versus IPR alone, and (4) families 
will rate this service delivery model as acceptable. 
 
Method 
Study Design. This study will be a two-arm randomized-controlled trial with 1 active 
intervention condition and 1 active control condition (1:1 allocation ratio). Procedures were pre-registered 
on ClinicalTrials.gov on 7/24/2019 (NCT04030897; anticipated date of first enrollment: 12/15/2019). The 
University Institutional Review Board (#IRB2019-00241) approved all study procedures on 7/8/2019. 
Project funding is provided by the Klingenstein Third Generation Foundation. 
Youths and parents will complete all study procedures remotely via personal internet-equipped 
devices. After discussing procedures with a research team member via telephone, eligible families will 
receive a study link from which parents and youths may provide consent and assent and complete their 
respective study portions. In separate Qualtrics-based surveys, parents and youths will complete baseline 
questionnaires, the GM-SSIs (or ‘waitlist’ notification; IPR will be provided to all families at initial PC 
appointments), and post-intervention questionnaires within a single online survey lasting approximately 
one hour per family member. Parent-youth pairs will both be assigned to the same condition (GM-SSI or 
‘waitlist’) via survey-embedded random-number generators; randomization will not be stratified. 
Subsequently, three-month follow-up questionnaires will be administered via Qualtrics-based surveys. 
Follow-up surveys will assess parents’ treatment-seeking behaviors, youth symptoms, parental stress and 
psychopathology, and related variables (detailed below). Families who do not complete follow-up surveys 

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within 3 days of contact will receive <3 reminder messages. After completion of the 3-month follow-up, 
families who did not initially receive GM-SSIs will be granted intervention access. 
Participants and Recruitment. We will recruit two-hundred youths ages 11-16 and one parent 
per youth from nine community-based branches of the University Hospital’s Pediatric Primary Care 
service. Per the University Medical Center’s policies, providers at all sites administer the youth-report 
Pediatric Symptom Checklist (PSC)13 to patients 11 and older. Providers review patients’ PSC scores 
during their appointments; all youths reporting symptom elevations receive an “Information, 
Psychoeducation, and Referral” folder, including contact information for local mental health providers 
and psychoeducational materials. In this study, youths with an elevated PSC-Internalizing Score (5/10 or 
higher, per 0-2 ratings of five items: Feel sad or unhappy, feel hopeless, down on yourself, seem to be 
having less fun, worries a lot) may be eligible for participation, per existing PSC-Internalizing cut-offs.14 
Because the PSC is already implemented and scored across participating clinics, and because PSC scores 
are used to direct distribution of “Information, Psychoeducation, and Referral” resource folders to 
patients, using the PSC as an eligibility screen creates no added clinical burden for providers. Within 3 
weeks of the youth’s PC appointment, a research team member will contact potentially eligible families 
by phone to introduce the study and invite them to participate. Additional inclusion criteria, assessed 
during this call, include English-language proficiency and comfort completing computer-based activities. 
Receipt of mental health services upon enrollment will be monitored but will not preclude participation.  
The parent- and youth-directed interventions last approximately 15-30 minutes. Thus, there is no 
plan to discontinue interventions due to worsening symptoms, but participants will be informed that they 
may stop participating in the study at any time without penalty. 
Sample size justification. First, using G*Power 3.1, we calculated samples needed to achieve 
80% power to detect a small (per Cohen’s recommendations: d=.2 or OR=1.49), medium (d=.5 or 
OR=3.45), and large effects (d=.8 or OR=9.00) effect on primary outcomes (parent treatment-seeking 
behaviors, per logistic regression, and youth depressive symptoms, per linear regression) at α=.05 for a 
two-arm RCT, including two covariates (baseline youth depression symptom severity; intervention 

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condition). Ns were 392, 55, and 25, respectively, for a regression predicting, and 615, 89, and 50, 
respectively, for a logistic regression predicting parent treatment-seeking behaviors at 3-month follow-up. 
However, it is necessary in this study to consider our multisite recruitment structure (9 sites total). GM-
SSIs have previously produced small-to-medium improvements in youth depressive symptoms and parent 
treatment expectancies; we thus used procedures outlined by Feaster, Mukulich-Gilbertson, and Brincks15 
to obtain more precise power estimates for a mixed-effects model predicting medium up (d = 0.5) changes 
in youth depressive symptom severity from baseline to 3-month follow-up, assuming low variability in 
treatment across sites (0.05). A target N of 246 (approximately 26-28 youths per site, although we cannot 
accurately project exact site-specific recruitment totals in advance) would ensure 92% power to detect an 
average intervention effect of d = 0.5 and 80% power to detect a minimum average effect size of d = 0.42. 
As such, a target N of 246 was selected for this study. Notably, participants will be randomized at the 
study level—not at the site level—ensuring an even number of families assigned to both study conditions 
overall. 
Intervention Descriptions 
Youth-Directed Growth Mindset (GM) SSI.10 The web-based, youth-directed GM-SSI is 
delivered via Qualtrics and is approximately 30 minutes long. All activities are self-administered and 
delivered in a web-based format, including illustrations, graphics, and audio-recordings. Content is 
designed to maximize relevance for youths experiencing depressive symptoms (e.g., sadness, 
hopelessness) and includes five components: 1. A brief lesson on neuroplasticity, describing how 
behaviors are controlled by thoughts and feelings in the brain, and thus have potential for change; 2. 
Stories from older youths describing beliefs that their traits (e.g., sadness, anxiety) are malleable; 3. 
Further stories by older youths, describing times when they applied this knowledge to cope with 
emotional setbacks; 4. Scientific studies suggesting that personality can positively change over time; and 
5. An exercise in which participants write notes to younger peers, using newly-gleaned knowledge to 
generate advice on coping with an emotional setback. Here, youths are presented with a hypothetical peer 
rejection scenario and respond to the following prompt: “How do you think you would feel if this 

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happened to you? What kinds of thoughts do you think you would have?” Next, youths are asked to 
“imagine that the same event you just wrote about happened to another kid just like you. What could you 
say to help them understand that they can change, or things that are happening to them could change?” 
Parent-Directed Growth Mindset (GM) SSI.12 The web-based, parent-directed GM-SSI takes 
15 minutes. Parents first read a brief passage, “Can We Change Our Emotions?” presenting data, 
quotations, and examples conveying the argument that emotions are inherently flexible in youths and 
adults. Parents then read another passage, “Is Failure a Friend or Foe?” illustrating the notion that failure 
promotes learning, growth, and self-reflection. After each passage, parents are asked to write a brief 
summary of its main arguments “as though you were trying to convince a fellow parent why the passage’s 
main arguments are true.” This exercise is designed to promote internalization of the passage’s ideas. 
To assess program completion, user-activity tracking markers will be embedded into our 
Qualtrics surveys for participants.  
Information, Psychoeducation and Referral (IPR). IPR represents usual care in the University 
Hospital’s Pediatric Primary Care Division; it is routine practice at all clinics in this study. All families of 
youths with elevated depressive symptoms during a PC visit receive a folder containing informational 
materials about the nature of depression and referrals to providers in their area. All families in this study 
will have received PC-based IPR before enrollment, per University Medical Center policy. 
Potential bias sources. Families will know whether they receive GM-SSIs immediately or after 
follow-up. To minimize other potential performance bias sources, families will be randomized remotely 
via online surveys; thus, the research team and PC providers will be blinded to condition. Second, some 
eligible families may have limited computer access, creating possible selection bias. We therefore 
designed study questionnaires and interventions to be completable on any internet-equipped device 
(smartphones, tablets, computers). Additionally, if an eligible youth with limited internet access is 
interested in participating in the study, research team members will work with the family to identify local 
venues where internet-equipped devices are accessible (e.g., public libraries/community centers). 

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Trial conduct. Data will be monitored on an ongoing basis (daily) for quality assurance purposes 
and to ensure protocol compliance. Further, we will follow University IRB policies for expedited adverse 
event (AE) reporting. The PI will review data for potential AEs in real-time throughout the trial; AEs 
occurring during the study will be reported to the IRB within 48 hours. Any protocol alterations that 
become necessary will be approved by the IRB before implementation.  
Data confidentiality and sharing statement. Data will be collected via Qualtrics and stored on 
password-protected electronic servers meeting University security standards. After the funding period 
concludes, de-identified participant-level data will be posted publicly via Open Science Framework 
(OSF). Intervention materials are available from the first author upon request. 
Measures (see Table 1 for SPIRIT information). 
Mental Health Treatment-Seeking Checklist (Co-Primary Outcome). At baseline and 3-
month follow-up, parents will indicate their engagement (‘yes’/‘no’) in four treatment-seeking behaviors 
for their child: researched local mental healthcare providers/agencies; contacted mental healthcare 
provider or agency about treatment; contacted child's school regarding mental health supports; and 
scheduled an appointment or placed child on waiting-list with a mental healthcare provider/agency 
(number of treatment-seeking behaviors ranges from 0-4). At baseline, parents will report whether they 
engaged in these behaviors since the child’s PC appointment, and at follow-up, since their last survey. 
Parent treatment-seeking will be a primary outcome. 
Children’s Depression Inventory-2 (CDI-2; Co-Primary Outcome). Parents and youths will 
complete the CDI-2 scale at baseline (pre-intervention) and 3-month follow-up. The CDI-2 is a reliable, 
valid measure of youth depression severity, normed for youth age and sex and yielding raw and T scores, 
along with an index of functional impairment. The CDI-2 is highly sensitive to clinical change across 
treatment and is used routinely in clinical trials for treating youth depression.3,7,10 Change in self-reported 
youth depressive symptoms will be a primary outcome; parent-reported youth depression symptoms is a 
secondary outcome. 

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Pediatric Symptom Checklist (PSC; Eligibility screener and secondary outcome). The PSC 
is a widely-used, validated measure of overall youth psychopathology, including internalizing, 
externalizing, attention, and total symptoms, based on 35 items rated 0-2.15 Because participating clinics 
administer the PSC during all PC visits, the PSC will serve as the study’s eligibility screener. Youth 
depressive symptoms will be indexed via the 5-item PSC Internalizing Subscale (score range 0-10). 16 A 
score of >5 will indicate possible trial eligibility. Receiver operating characteristics analyses suggest that 
the PSC-17 Internalizing subscale performs as well as competing screens (e.g., the Children’s Depression 
Inventory and Child Behavior Checklist) in predicting depression diagnoses based on clinical interviews 
(AUC>0.80).16, Youths and parents will also complete the full PSC-17 at baseline and follow-up; changes 
in overall youth- and parent-reported youth psychopathology will be secondary outcomes. 
Beck Hopelessness Scale-Short Version (BHS-4). The BHS-418 is a valid, reliable 4-item 
version of the 20-item BHS19 assessing hopelessness in youths and adults.20,21 Parent and youth self-
reported hopelessness will be assessed at baseline, post-intervention (if assigned to the IPR+SSI group), 
and follow-up. Higher sum-scores (range: 0-12) reflect greater hopelessness.  
Brief Symptom Inventory-18 (BSI-18). The BSI-18 is a reliable, validated measure of self-
reported psychopathology and distress.22,23 At baseline and 3-month follow-up, parents will rate 
endorsement of 18 physical and emotional complaints from 0-4. Sum scores yield a total distress score 
(range: 0-72). 
Barriers to Accessing Care Evaluation (BACE). The BACE is a well-validated assessment of 
the degree to which beliefs, concerns, and circumstances have stopped or discouraged individuals from 
accessing youth mental health services.24-26 At baseline and follow-up, parents will rate its 30 items on a 
0-3 scale. Higher scores (range: 0-90) indicate greater service access barriers. 
Attitudes Toward Therapy Scale. This single-item scale assesses parents’ perceptions that 
therapy/counseling would help reduce their child's mental health difficulties.12 At baseline, post-
intervention (if assigned to IPR+SSI), and 3-month follow-up, parents will rate the item from 0-10. 
Higher scores indicate stronger beliefs that therapy may help reduce mental health problems. 

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Mental Health Treatment Access. Parents will indicate (yes/no) whether their child has 
received (a) new and/or (b) continuing school-based, outpatient, or other mental health-related services 
since the child's recent PC appointment (at baseline) and since the baseline assessment (at follow-up). 
Perceived Stress Scale. The PSS is a validated measure of one’s appraisal of daily life as 
stressful, unpredictable, and uncontrollable.27,28 At baseline and follow-up, parents will rate 10 items from 
0-4, with higher scores indicating greater perceived stress (range: 0-40). 
Implicit Theories of Emotion Scale. The ITE Scale29,30 will serve as a manipulation check for 
the parent-directed GM-SSI. At baseline and post-intervention (IPR+SSI group only), parents will report 
the degree to which they view emotions as malleable (versus immutable) on a 1-6 scale across four items. 
Higher mean scores (range: 1-6) indicate stronger fixed emotion mindset, and lower scores, stronger 
growth emotion mindset. 
Implicit Theories of Personality Questionnaire. The ITPQ31 will be used as a manipulation 
check for the youth-directed GM-SSI. At baseline and post-intervention (IPR+SSI group only), youths 
will rate agreement with three statements linked to malleability of personality. Higher mean scores 
indicate stronger fixed personality mindsets, and lower scores, stronger growth personality mindsets 
(range: 1-6). 
Intervention Feedback Scale. Immediately post-intervention, the Intervention Feedback Scale32 
will ask youth and parents receiving GM-SSIs to indicate how much they enjoyed, understood, felt helped 
by, would recommend, and agreed with the program’s message. They will also be prompted to provide 
written feedback regarding their impressions of the program. 
Adverse Childhood Experiences (ACEs). The ACEs questionnaire is a well-validated measure 
of exposure to violence, childhood emotional, physical, or sexual abuse, and household dysfunction 
during childhood.33,34 Parents will complete the ACEs questionnaire at baseline in reference to their child 
and to themselves.1  
 
1 We do not plan to use the ACEs questionnaire in primary study analyses. Rather, we are including this 
questionnaire to allow for future tests of whether trauma exposure influences GM-SSI intervention 

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Demographics. Parents will report family and background information (e.g. youth age, sex, 
mental health treatment history). 
Analytic Plan  
Manipulation check. Two paired-samples t-tests will assess whether youths and parents 
receiving GM-SSIs report significant pre-to-post-SSI increases in growth mindset of personality and 
emotion, respectively. 
Intervention effects on parent treatment-seeking. We will run two mixed effects regressions 
(one mixed effects linear regression; one mixed effects logistic regression) to test whether IPR+SSI, 
versus IPR alone, increases parents’ treatment-seeking behaviors (Hypothesis 1). Treatment-seeking will 
be operationalized in two ways: as a continuous outcome (total number of treatment-seeking behaviors), 
and a binary outcome (whether or not any treatment-seeking occurred). Both the linear and one binary 
logistic regression models will include intervention condition and baseline youth-reported depression 
symptom severity, with recruitment site included as a random effect. (Although randomization will occur 
at the patient level, our trial includes multiple sites, and current practice suggests that sites should be 
included in models as random effects.15 While not strictly necessary for a balanced study in the absence of 
variability in intervention effects among sites, this is a more conservative, generalizable approach.) A 
significant effect of condition on the outcome would indicate that IPR+SSI, versus IPR alone, led to 
differential increases in the amount of treatment seeking (linear model), presence of treatment seeking 
(logistic model), or both. Significant effects per either or both models would suggest support for 
Hypothesis 1. 
Intervention effects on youth internalizing symptoms. A mixed effects linear regression will 
include Intervention Condition and baseline self-reported youth depressive symptom severity, with 
recruitment site included as a random effect. A significant effect Intervention Condition would indicate 
 
response. Any such analyses we decide to pursue will be pre-registered at a later date as exploratory, 
secondary tests.  
 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
          16 
that IPR+SSI, versus IPR alone, led to differential reductions in self-reported youth internalizing 
symptoms from baseline to 3-month follow-up (Hypothesis 2). An additional parallel model will be 
conducted to assess change in parent-reported youth depressive symptoms (a secondary outcome). 
Intervention effects on parental distress and stress. Two additional mixed effects linear 
regressions, structured and interpreted in the same fashion as those for Hypothesis 2, will assess 
Hypothesis 3. Outcomes will be parent perceived stress and parent psychological distress. 
Acceptability of service delivery model. Critical metrics will include SSI completion rates and 
ratings of SSIs as helpful, enjoyable, easy to understand, and worth recommending to others. Acceptable 
completion rates (>60%: above mean completion rates for outpatient youth psychotherapy36) and mean 
ratings of >4/5 on acceptability items would suggest service model acceptability. 
Missing data. We will apply multiple imputation (20 imputations) to address any item-level 
missing data and maximum likelihood estimation for subject-level missing data in regression analyses. 
Multiple imputation will be applied to all variables for which missing item- or subject-level data emerge. 
Covariates. Potential covariates will include family income, youth age, and youth sex. Each 
covariate will be included only if it correlates significantly with condition assignment. 
Correction for multiple tests. The false discovery rate (FDR)37 will be applied to identify 
potential false-positive results. Q-values will be computed for p-values from regression models using an 
online calculator applying Benjamini and Hochberg’s37 approach 
(www.sdmproject.com/utilities/?show=FDR). Results will be considered significant if FDR-corrected 
q<0.05 (incurring maximum 5% false-positive rate amongst all tests meeting significance at p<0.05). To 
ensure rigorous tests of statistical significance, results of all pre-registered statistical tests of primary and 
secondary hypotheses (H1-H4) will be included in computations of FDR-corrected significance levels. 
Study timeline. Recruitment is projected to begin by January 2020 and extend until the target 
sample is achieved. Recruitment, intervention administration, and follow-up assessments are projected to 
be complete by June 2021, and data processing and analysis, by August 2021 (end of the grant period). 
 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
          17 
 
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Table 1. Schedule of enrollment, interventions, and assessments. 
Schedule 
Study Period 
  
  
  
  
  
Enrollment 
Allocation 
Post-allocation 
  
Follow-up 
  
  
(baseline) 
  
  
(3-months) 
  
  
  
Intervention 
administration 
Immediate post-
intervention 
  
Enrollment 
  
  
  
  
  
Eligibility screen 
X 
- ª 
- 
- 
- 
Informed consent/assent 
X 
- 
- 
- 
- 
Allocation 
- 
X 
- 
- 
- 
Interventions b 
  
  
  
  
  
Youth-directed GM SSI c 
- 
- 
X 
- 
- 
Parent-directed GM SSI d 
- 
- 
X 
- 
- 
IPR only (control) e 
- 
X 
- 
- 
- 
Assessments 
  
  
  
  
  
Youth self-report 
  
  
  
  
  
Pediatric Symptom Checklist 
- 
X 
- 
- 
X 
Children’s Depression Inventory-2 
- 
X 
- 
- 
X 
Beck Hopelessness Scale-Short form 
- 
X 
- 
X 
X 
Implicit Theories of Personality Questionnaire 
- 
X 
- 
X 
- 
Intervention Feedback Scale 
- 
- 
- 
X 
- 
Parent report 
  
  
  
  
  
Demographics 
- 
X 
- 
- 
- 
Children’s Depression Inventory-2 
- 
X 
- 
- 
- 
Adverse Childhood Experiences Questionnaire 
- 
X 
- 
- 
- 
Mental Health Treatment-Seeking Checklist 
- 
X 
- 
- 
X 
Pediatric Symptom Checklist 
- 
X 
- 
- 
X 
Brief Symptom Inventory 
- 
X 
- 
- 
X 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
          21 
Barriers to Accessing Care Evaluation 
- 
X 
- 
- 
X 
Mental Health Treatment Access 
- 
X 
- 
- 
X 
Perceived Stress Scale 
- 
X 
- 
- 
X 
Attitudes Toward Therapy Scale 
- 
X 
- 
X 
X 
Beck Hopelessness Scale-Short form 
- 
X 
- 
X 
X 
Implicit Theories of Emotion Scale 
- 
X 
- 
X 
- 
Intervention Feedback Scale 
- 
- 
- 
X 
- 
 
Note. ª Not applicable. b Youth-directed SSI ~30 minutes; parent-directed SSI ~15 minutes; youth-parent 
pairs randomized to both receive interventions or both receive no intervention. c Youth-directed growth 
mindset intervention. d Parent-directed growth mindset intervention e Information, psychoeducation, and 
referral only (control). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
          22 
 
Figure 1. Outline of Study Procedure 
 
Note. IPR = Information, Psychoeducation, Referral. GM-SSI = ‘Growth Mindset’ 
Single-Session Intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 

SINGLE-SESSION INTERVENTIONS YOUTH PRIMARY CARE 
 
 
          23 
 
Figure 2. Theoretical model illustrating potential patterns of single-session intervention 
effects. 
 
Note. Top panel (A) reflects potential differential intervention effects on co-primary 
outcomes. Lower panel (B) reflects potential simultaneously intervention effects on co-
primary outcomes.