Running head: PROTOCOL FOR SHAMIRI GROUP INTERVENTION 1

The Shamiri Group Intervention for Adolescent Anxiety and Depression:

Study Protocol for a Randomized Controlled Trial of a Lay Counselor-Delivered Intervention

Low-resource Schools in Kenya

Tom L. Osborn1*, Katherine Venturo-Conerly1*, Micaela Rodriguez1, Akash R. Wasil2

Elizabeth Roe1, Susana A Gaviria1, Rediet Alemu1, Jenny Gan1, Tomasz Cienkowki1

Jessica L. Schleider3, John R. Weisz1

1
Department of Psychology, Harvard University
2
Department of Psychology, University of Pennsylvania
3
Department of Psychology, Stony Brook University

Corresponding Author:

Tom L. Osborn

Email: tomleeosborn@gmail.com

Phone: 1-617-669-7297

Author Note:

This research is supported by grants from the Weatherhead Center for International Affairs at

Harvard University, Center for African Studies at Harvard University, the Harvard College

Research Program and the Office of Career Services at Harvard University.

*
These authors contributed equally to this work and share first authorship.
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 2

Abstract

Keywords:
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 3

The Shamiri Group Intervention for Adolescent Anxiety and Depression:

Study Protocol for a Randomized Controlled Trial of a Lay Counselor-Delivered Intervention in

Low-resource Schools in Kenya

Developing low-cost and scalable interventions for youth depression and anxiety in low-

income regions such as countries in Sub Saharan Africa is presently a critical priority of global

mental health research (Collins et al., 2011). The need for such interventions is warranted

because while the incidence of youth depression and anxiety is on the rise, less than half of

youths with internalizing problems receive needed care (World Health Organization, 2017). In

low-income regions, the burden of youth depression and anxiety is further compounded by

limited treatment options (Patel, Flisher, Hetrick, & McGorry, 2007), social stigma that prevents

help-seeking (Getanda, Papadopoulos, & Evans, 2015), and government under-investment in

mental healthcare resources (Caddick, Horne, Mackenzie, & Tilley, 2016; Patel et al., 2007). In

addition, the socio-economic stress associated with poverty (i.e. exposure to violence, inadequate

basic needs etc.) makes individuals in low-income communities more susceptible to developing

psychological disorders (Kilburn, Thirumurthy, Halpern, Pettifor, & Handa, 2016). As a majority

of psychological disorders begin during adolescence and influence future life outcomes (Patel et

al., 2007), the need for accessible interventions for youths in Sub Saharan Africa cannot be

overstated. The goal of this paper is to describe the study protocol for a randomized control trial

of one such intervention with high-symptom youths in Kenya.

The limited attempts at developing interventions for youth depression and anxiety in Sub

Saharan Africa have focused on high-risk youths and have been derived fully or partially from

formal psychotherapy interventions for mental disorders (Osborn, Wasil, Venturo-Conerly,

Schleider, & Weisz, 2019; Yatham, Sivathasan, Yoon, da Silva, & Ravindran, 2018). These
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 4

previous interventions have included elements of cognitive behavioral therapy (Kumakech,

Cantor-Graae, Maling, & Bajunirwe, 2009; Ssewamala, Neilands, Waldfogel, & Ismayilova,

2012) or adaptations of Western protocols such as the interpersonal therapy for adolescents (IPT-

A) (Bolton et al., 2007). Two major limitations of this approach to developing youth mental

health interventions in low-income regions are that: 1) proper delivery of interventions grounded

on formal therapy procedures necessitate a need for rigorous training of lay clinicians which

poses a barrier to dissemination and scalability, and 2) formal therapy procedures make reference

to depression and anxiety thus limiting help-seeking because of cultural stigma. Given the stigma

associated with mental health problems in low-income countries (see Shidhaye & Kermode,

2013), interventions that use non-pathologizing and non-stigmatizing language may be especially

useful. As such, interventions that can circumvent the above barriers might be particularly useful.

One such intervention is the Shamiri (‘thrive’ in Swahili) group intervention for youth

depression and anxiety that is delivered by lay counselors in school settings (Osborn, Wasil, et

al., 2019).

The Shamiri intervention draws upon evidence-based components of brief scalable

interventions that involve non-clinical psychological principles (rather than treatment of

psychopathology). Specifically, Shamiri draws on previous research on brief single-component

interventions that are sometimes called “wise interventions”, (Walton, 2014; Walton & Wilson,

2018), some of which have been found to improve youth mental health outcomes (Schleider,

Mullarkey, & Chacko, 2019). Not only are wise interventions (WIs) brief and require minimal

training of lay providers, they also place emphasis on overall human functioning rather than

referencing the treatment of mental health disorders. Thus, wise interventions may circumvent

social stigma in a way that formal psychotherapy techniques do not (Schleider, Mullarkey, &
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 5

Chacko, 2019; Schleider et al., 2019). The specific WI components of the Shamiri protocol are

growth-mindset (Schleider & Weisz, 2016, 2018), gratitude (Froh, Kashdan, Ozimkowski, &

Miller, 2009), and value affirmations (Cohen, Garcia, Purdie-Vaughns, Apfel, & Brzustoski,

2009). In a randomized trial of Shamiri with high-symptom Kenyan youths (N = 51, ages 14 -

17), adolescents who met a clinical cut-off for depression and anxiety were randomized into

either the Shamiri intervention or an active study-skills control group. Adolescents in the

intervention group showed improvements in youth depression and anxiety symptoms, academic

performance and perceived social support from friends (Osborn, Wasil, et al., 2019). However,

the trial was limited by a modest sample size that suggests that a replication of the Shamiri

intervention with large sample size is a logical next step.

This study has two primary objectives. The first is to evaluate an enhanced Shamiri group

intervention for depression and anxiety for youths with elevated symptoms in Kenya – the

intervention will aim to be low-cost, use positive psychology to circumvent stigma, and rely on

empirically supported principles that can be delivered in a low-resource community setting by

lay providers. The second is to conduct a moderator analyses on study outcomes to identify

whom the treatment works and under what circumstances.

The primary outcomes of measures of the present study are youth depressive and anxiety

symptoms. The secondary outcomes measures are social support, perceived control, gratitude,

loneliness, emotional regulation, and academic outcomes. We predict that youths assigned to the

Shamiri intervention will experience reductions in primary outcome measures and improvements

in secondary outcomes measures when compared to youths assigned to an active “study-skills”

control group.
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 6

Methods

Study Design

Trial design.

The trial is a randomized trial with two arms: the Shamiri intervention and a study-skills

control intervention. The intervention and control conditions are described in detail later and

summarized in Table 1. Interventions will be delivered in schools by high school graduates

trained to be lay providers with youths in groups of 6-12 (more information below). Assessments

will be administered at initial screening, 2-week midpoint, 4-week endpoint, and 6 weeks after

study completion. Academic performance data will be collected for the school-term before and

after study participation.

Study setting.

This study will take place in four secondary schools located in Nairobi County, Kenya.

Nairobi is the capital of Kenya, a low-income country in Sub-Saharan Africa, and is considered a

diverse city that is representative of the cultural and socio-economic diversity in Kenya (Kenya

National Bureau of Statistics, 2009). The first author will draw a list of eighteen public

secondary schools in Nairobi and its environs. Headteachers of the schools will be contacted

with information about the study and requested to enlist their school to participate. From the pool

of interested schools, four schools will be selected in a manner that ensures that the resulting

sample of schools consists of two female and two male schools—as most public secondary

schools in Nairobi are single sex— that are strong in demographic, socioeconomic and

educational diversity (see Osborn, Venturo-Conerly, Wasil, Schleider, & Weisz, 2019 for more

information on such diversity in Nairobi secondary schools). This will enable us to potentially

recruit a sample that will allow us the ability to conduct a robust moderator analyses while also
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 7

strengthening our capacity to achieve results that are generalizable to high-symptom youth in

Kenya.

Participant recruitment and screening.

In all the four participating schools, students between the ages of 12 and 19 will be

notified about the study by the school headteachers and other administrators. The school

administrators will then gather interested students in classrooms. All students will be eligible for

the study if they either self-report elevated depression or anxiety symptoms — indexed by a

score of 15 or higher on the Patient Health Questionnaire (PHQ)-8, indicating moderate or severe

depression, or a score of 10 or greater on the GAD-7, indicating moderate or severe anxiety

(Kroenke & Spitzer, 2002; Kroenke, Spitzer, Williams, & Löwe, 2010)— and no other exclusion

criteria will be applied.

Students will complete a questionnaire battery to determine study eligibility. Consistent

with school policy and local custom (which assigns school administrators the authority to make

decisions about student activities, including research), the school principals will represent

parents in receiving information about the study and having an opportunity to ask questions, they

will then provide informed consent for this battery. The students will be informed that

participation is voluntary and that they can opt out. They will also be provided with an

opportunity to ask questions, after which they will also provide informed consent. See Figure 1

for a participant flowchart.

Sample size and statistical power.

To detect a medium effect size of d = 0.3 with p = 0.05 at 80% power, 210 participants

are required per group for a total of at least 420 participants. Assuming that 30% of youth will be

eligible for the study based on their PHQ-8 and GAD-7 scores (based on Osborn, Venturo-
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 8

Conerly, et al., 2019 assessment that approximately 30% of high school youths in Nairobi have

moderate to severe depression and anxiety) and a dropout rate of 10%, at least 1500 youths are

needed for baseline screening to realize the necessary sample size. Based on the results of our

previous studies in schools in Nairobi in 2018, this sample size is believed to be feasible.

Randomization and treatment allocation.

Following baseline assessment and recruitment, youths who meet the inclusion criteria

will be randomly allocated to the Shamiri intervention or the study-skills control condition using

a computerized random number generator. Upon randomization, youths in both groups will be

assessed to ensure that no significant differences emerge on demographic characteristics or

symptom levels and that randomization is successful. Should this not be the case, eligible youths

will be randomized again until this objective is achieved.

Group Leader Selection and Training

Both the Shamiri and study-skills groups will be led by trained group leaders who will

serve as lay-providers. To qualify to be a group leader, an individual will have to be Kenyan

(specifically from the local community in Nairobi), a high school graduate, and in the 17-21 age-

group. While most group leaders will be either planning to matriculate or already attending a

local university in Nairobi, college admittance or attendance is not a requirement for

consideration. The above requirements are important for the successful implementation of this

protocol for a variety of reasons: 1) local group leaders are culturally attuned to the local customs

of the schools in a way that outsiders are unable to, making them best-placed to deliver the

intervention effectively than outsiders, 2) group leaders who are closer in age to the youths in the

program maybe be better positioned to connect with youths in the group than older adults — this

is because cultural norms around age relations dictate that youths should primary listen and not
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 9

talk in the company of adults— and, 3) this model is potentially scalable because there are many

Kenyan youths in the age group of 17-21 (mean age is 19; Awiti & Scott, 2016).

We plan to recruit group leaders through advertisements in high school graduate

platforms on various media such as WhatsApp and Facebook, local universities in Kenya, and

through local organizations who work with high school graduates. All interested group leaders

will be offered an opportunity to express their interest via a brief online form. Group leaders who

meet the above-specified criteria will be invited for a brief 20-30-minute interview with

members of the study team. This interview will assess past experiences, interest in the project,

familiarity with mental health issues, and interpersonal facilitation skills. Due to funding

constraints, we intend to recruit between 10-12 group leaders. All group leaders will be

compensated $180 for the entire duration of the study.

Group leader training, which will be done by members of the research team, will begin

with general communication and group leadership skills such as active listening, noting

connections between the group members, handling conflicts within the group, and referring

students in need to appropriate school official. Group leaders will then be trained didactically in

the specific content of each week of the interventions. All group leaders will receive detailed and

structured outlines with the content of each intervention and control sessions that shall include

sample wording (a protocol for group-leader selection and training will be available in the near

future).

Upon completion of training, group leaders will be randomly assigned to intervention or

control groups. Given that we will have about 40 groups of 8-12 youths in the entire study, group

leaders will be assigned to both conditions in different schools. That is, one group leader might

lead a study-skills control group in School A but a Shamiri intervention group in School B. This
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 10

randomization should allow us account for group leader differences in competence. Group

leaders will be instructed to strictly follow the protocol manual for the condition that they will be

leading and not use content from the other condition during their sessions.

Intervention arms.

Shamiri Intervention.

The Shamiri intervention consists of three modules: a growth-mindset module (Schleider

& Weisz, 2016, 2018) lasting two sessions; a gratitude module (Froh et al., 2009) lasting one

session; and a value affirmations module (Cohen et al., 2009) lasting one session. Information on

these sessions is provided below.

Growth-mindset interventions. Growth-mindset interventions target implicit theories

about the malleability of human characteristics. As such, growth-mindset interventions challenge

the notion that characteristics such as personality traits and intelligence are fixed and

unchangeable. They attempt to strengthen individuals’ beliefs in the malleability of such

characteristics (See Dweck, 2008; Dweck, Chiu, & Hong, 1995; Yeager & Dweck, 2012) for

more information).

Gratitude interventions. Gratitude interventions are derived from research on trait

gratitude that suggests that grateful people exhibit positive states and outcomes. These

interventions attempt to teach individuals to be more thankful for things they have received that

are beneficial, whether tangible or not (see Froh et al., 2009 for more information).

Value affirmations. Value affirmation interventions allow people to reflect on self-

identified values. This self-reflection reestablishes an awareness of personal worth and integrity,

a process that affords them an opportunity to mobilize the internal resources needed for coping

(see (Cohen et al., 2009; Miyake et al., 2010) for more information).
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 11

Structure of intervention sessions. There are four intervention sessions are one-hour long

and one-week apart. Homework exercises are provided between-session. In session one and two,

participants learn about growth-mindsets. In session three and four, participants learn about

gratitude and value affirmations respectively. All the seasons include reading activities, group

discussions, and writing activities.

In session one, the group leader begins by offering a didactic introduction to growth,

personal improvement and its benefits. Participants then read and discuss an article and video

that describe the brain and concepts of neuroplasticity and growth mindset. After this, the group

reads testimonials about growth mindsets from well-known figures and hear their group leader’s

testimonial. All testimonials focus on personal growth in diverse domains (e.g. intelligence,

personality, social etc.). Participants then have a discussion on the testimonials. After this,

participants are given a homework exercise which is to write their own growth story. In this

assignment, they will be expected to write a growth story that includes a challenge they faced,

how they used effort or a strategy to deal with the challenge and any setbacks that they faces, and

finally how they learnt or grew as a result of the challenge.

In session two, participants begin by discussing their homework. They then brainstorm

and discuss effective strategies that they can use to apply the lessons of growth-mindset in their

own lives. They then talk about problem-solving skills in a discussion moderated by the group-

leader. After this, the students write a letter to a friend in which they explain all the concepts that

they have learnt thus far, including neuroplasticity, growth-mindset, effective strategies, and

problem-solving skills, to a friend. Participants are then offered an opportunity to voluntarily

read out their letters (should no student offer to read their letter, the group leader will read their

own letter). After this, the participants are given a homework exercise on problem-solving in
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 12

which they think of a problem that is affecting or bothering them and brainstorm solutions which

they will fill out in their homework sheets.

In session three, students learn about gratitude. In a similar way to the growth-mindset

module, the group leader opens the session with a didactic introduction to gratitude and its

benefits. The group then discusses gratitude and the things for which participants are grateful.

After this, participants write a “gratitude letter” (Toepfer, Cichy, & Peters, 2012) to someone

who has changed their life for the better. For homework, participants will complete a daily “three

good things” activity for one week (Emmons & McCullough, 2003), identifying, each day, three

good things that happened and reflecting on those things.

In session four, students learn about virtues and complete a value affirmation exercise. In

this session, the group leader begins with a similar didactic introduction, explaining what virtues

are and engage in a group discussion about values and virtues1. Students are then asked to select,

from a list, several values that were important to them and to write in more detail about the one

value that they feel is most important to them, describing why this value is important, and

describing a time when they have lived up to that value, and noting in what ways they can live in

better accord with this value in the future (Cohen et al., 2009). There is no homework following

this last session. At this point, participants are provided with the Shamiri booklet – a booklet that

contains all the lessons and exercises from the four sessions.

1
In a prior trial of Shamiri, it was found from participant feedback that the word virtue best
described values in the local context, as such we use both values and virtues as if they were
interchangeable, see Osborn, Wasil, et al., 2019 for more information.
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 13

Study-skills control

A study-skills control intervention is beneficial for a couple of reasons. First, by focusing

on useful academic content, all participants are presented with an opportunity to benefit from

participation. Second, it has been shown that active control groups provide more a more rigorous

standard of comparison when compared to a passive controls (Weisz et al., 2017).

To control for non-specific aspects of the intervention, the study skills control group

(developed for the present study) will mirror the structure of the intervention conditions. The

number of exercises and group discussions are the same, within-session activities are similar in

format (e.g., reading, writing, and discussion activities), and between-session homework activity

requires similar effort. The content focuses on study skills such as note-taking, effective reading

strategies, and tips for time management. Like Shamiri sessions, each study-skill session consists

of a didactic introduction by group leaders on the specific study skill for the week, group

discussions, writing activities and other exercises that help students practice and better

understand how to use the study skills they are taught, and receive between-session homework.

Intervention fidelity.

We will assess intervention fidelity —including group leader adherence to protocol

manual and group leader competence in delivering the Shamiri and study-skills interventions—

using a fidelity rubric (see Table 3) developed by the investigators. In this rubric, sessions are

broken down into small 5-10-minute chunks that reflect the activities which are outlined in the

protocol manual. Raters will listen to and rate these chunks. They will code group leader

adherence to protocol manual (i.e. whether a group a leader followed manual and delivered

required content classified as 0=no, 1=yes) and group leader competence (i.e. effectiveness in

communicating concepts and skillfulness of delivery etc., rated from 1=not-competent to 5=very
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 14

competent). Rater (N = 2) will be recruited from a psychology or social science department at the

local universities in Nairobi. They will then undergo training that will consist of didactic training

on protocol manual of both Shamiri and study-skills group, a training of the fidelity rubric, and

training on the 5-10-minute chunks. They will then listen to a randomly selected sample from

each of the conditions, and rate them independently. After this, they will work with a member of

the study team and walk through their ratings. After this, the raters will grade a randomly

selected 30% of the audio-recordings of the Shamiri and study-skills sessions. The raters will be

blind to study purposes.

Measures

Primary outcome measures.

Patient Health Questionnaire-8.

We will use the 8-item version of the PHQ-9, the PHQ-8 to assess youth depression

symptoms. PHQ-8 scores are highly correlated with PHQ-9 scores, and the same cutoffs can be

used to assess depression severity (Kroenke & Spitzer, 2002). PHQ-8 has been validated for use

in Kenyan adolescents (Cronbach alpha=.73; Osborn, Venturo-Conerly, et al., 2019).

Generalized Anxiety Disorder Screener-7.

The GAD-7 (Spitzer, Kroenke, Williams, & Löwe, 2006) is a measure used globally to

screen for generalized anxiety disorder in adolescents and adults. GAD-7 has been validated for

use in Kenyan adolescents (Cronbach alpha=.78; Osborn, Venturo-Conerly, et al., 2019).

Secondary outcome measures.

Academic performance.

Academic grades of the participants will be collected for the school-term before the

intervention (January to April 2019) and the school-term after the intervention (September to
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 15

November 2019). Schools have different customs regarding student subject enrollment, but in

most cases, students are expected to enroll in between 6 to 12 subjects. We will use a student’s

average grade (mean grade across all enrolled subjects) to determine their academic performance

per semester. We will also examine the student’s grade in math and science (mean grade across

biology, physics and chemistry). As schools will provide us with an unstandardized academic

grade, in order to compare scores between students in different grades, across different exams

and in different schools, we will convert the academic grades to standard scores (M=60, SD =

10, chosen arbitrarily and used in rescaling). For each student, we will thus calculate a mean

standard score across all exams, and a mean standard score across math and science exams only.

Multidimensional Scale of Perceived Social Support.

The MSPSS (Zimet, Dahlem, Zimet, & Farley, 1988) is designed to measure satisfaction

with social support. It consists of three subscales: the “friends” subscale, which measures

supporting from friends, the “family” subscale which measures support from family, and the

significant others subscale, which measures support from significant others. The MSPSS has

demonstrated adequate internal consistency in Kenyan adolescents (Cronbach alpha=.86;

Osborn, Venturo-Conerly, et al., 2019).

Perceived Control Scale for Children.

PCS (Weisz, Southam-Gerow, & Sweeney, 1998) includes 24 items related to beliefs

about personal control, specifically, the belief that one can obtain desired outcomes and avoid

undesired outcomes through effort. Example items include, “I can make friends with other kids if

I really try” and “I cannot stay out of trouble no matter how hard I try”. The PCS has

demonstrated adequate internal consistency Kenyan adolescents (Cronbach alpha=.78; Osborn,

Venturo-Conerly, et al., 2019).

PROTOCOL FOR SHAMIRI GROUP INTERVENTION 16

The Gratitude Questionnaire (GQ-6).

The Gratitude Questionnaire (GQ-6) is a six-item self-report questionnaire that measures

grateful disposition, particularly, it measures individual differences in the proneness to

experience gratitude in life. It has been shown to have strong psychometric properties in Kenyan

youths (McCullough, Emmons, & Tsang, 2002). A previous attempt to us the GQ-6 with Kenyan

youths demonstrated weak internal consistency and feedback data suggested that the reading

level of the measure should be revised for Kenyan youths (α = 0.56; Osborn, Venturo-Conerly, et

al., 2019). We will use a modified GQ-6 that is accessible to Kenyan youths of diverse reading

levels.

Secondary Control Scale for Children (SCSC).

The SCSC (Rothbaum, Weisz, & Snyder, 1982) is a 20-item scale measuring youth’s

perceived ability to adjust their self-structure to the impact of objective conditions to their selves.

Youth rate agreement with items that echo several kinds of secondary control including adjusting

cognition (“When something bad happens, I can find a way to think about it that makes me feel

better”). The SCSC has shown acceptable reliability and validity in a large youth sample in

North America but has not been validated in Sub Saharan African samples.

The EPOCH Measure of Adolescent Well-Being.

The EPOCH Measure of Adolescent Well-Being assess positive psychological

characteristics that might foster well-being, physical health, and other positive outcomes in

adulthood. While the EPOCH has been validated with adolescents in Australia and the United

States (Kern, Benson, Steinberg, & Steinberg, 2016), it is yet to be validated with adolescents in

Kenya and other Sub Saharan African countries. We will use the Optimism, Perseverance and

Happiness subscales of the EPOCH.

PROTOCOL FOR SHAMIRI GROUP INTERVENTION 17

UCLA Loneliness Scale – Shortened Version.

The UCLA Loneliness Scale is a widely validated tool for measuring trait loneliness.

Participants read eight different statement such as “I feel isolated from others and people are

around me but not with me” and rate their responses on a 4-point Likert scale. The third and

newest edition of the UCLA Loneliness Scale has demonstrated high reliability, construct

validity, and discriminant validity (Russell, 1996). We will use a shortened version of the scale

(8-item) of the UCLA Loneliness Scale which shows similar validity and reliability with the 20-

item standard scale (Russell, 1996).

Program feedback scale.

A feedback scale will be used to collect acceptability and feasibility data from

participants. The youths will be asked questions on the usefulness of the program, their

experience with the intervention which they are assigned, whether they understood the program,

whether they would recommend the program to a friend. They will also write in their own words

their favorite aspect of the program and recommend changes. This scale was developed

specifically for this study; several items were drawn from prior research (Osborn, Wasil, et al.,

2019; Schleider, Mullarkey, & Weisz, 2019). The scale is available in Table 2.

Timeline for study and data collection.

Participant recruitment will begin in June 2019. The intervention will take place in June

and July 2019. Data collection will continue until December 2019. We intend to report results by

Spring 2020. Upon completion of data collection and publication of results, we will avail de-

identify participant-level data publicly. We cannot provide identifiable data about participants

and schools.
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 18

Data analysis plan

Primary analysis.

Outcome measures that have not demonstrated prior internal consistency with Kenyan

youths will need to demonstrate such consistency as indexed by a Cronbach’s alpha of at least

0.70 (Nunnally, 1978) to be considered for further analyses.

We will use an intent-to-treat approach, including all participants who will be

randomized. We will run a linear mixed model comparing intervention and control groups on

each primary and secondary outcome. Models will be organized to reflect the hierarchical

structure of the data. Different assessment points were nested within participants. All models will

include a random intercept that will allow for individual variation at baseline. We will include a

random slope that will allow for individual variation in outcome change rates; however, should

this result in overfitting (i.e. random effects structure becoming too complex to be supported by

the data), we will remove the random slopes to allow for more parsimonious models. Time,

intervention condition, and their interaction will be included in all models. Covariates will

include age (in years), sex and school. Age will be included because older adolescents are

reported to face increased psychosocial stress, which may exacerbate depressive and anxiety

symptoms (Osborn, Venturo-Conerly, et al., 2019; Philias & Wanjobi, 2011). Sex will be

included because gender differences in internalizing problems have been documented in Kenyan

adolescents (Mitchell & Abbott, 1987; Osborn, Venturo-Conerly, et al., 2019). School will be

included because students in resource-poor schools in Kenya have reported higher anxiety

symptoms (Osborn, Venturo-Conerly, et al., 2019). Significant (p < .05) condition * time

interactions in predicted directions will indicate that the intervention condition produced more

rapid improvements in outcomes across the study period, as compared to the control.
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 19

Additionally, we will calculate effect sizes (ESs) using differences in means; these ESs

will compare mean gain scores (Cohen’s d) reflecting changes in each outcome from baseline to

post-treatment for youths in the Shamiri intervention versus study skills control intervention.

Statistically significant, positive Cohen’s d values will indicate greater improvements for

intervention group youths versus control group youths.

Participants who miss a session will be allowed to attend other sessions in the future.

Missing item (measurement) and subject-level data will be imputed five times using Fully

Conditional Specification (FCS), implemented using the multivariate imputation by chained

equations (mice) algorithm in R as described by Buuren & Groothuis-Oudshoorn (2011).

Moderator analysis.

Ethical Considerations

The Harvard University Institutional Review Board will approve the study protocol prior

to data collection.

Discussion
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 20

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PROTOCOL FOR SHAMIRI GROUP INTERVENTION
Tables and Figures
Table 1
Arms of the Shamiri Randomized Control Trial
Study Arm Content
Consists of four sessions
Shamiri intervention made up of three modules:
growth-mindset (two
sessions), gratitude (one
session), and value
affirmations (one session).
Consists of four sessions with
Study-skills control content that focus on study
skills. Specific modules will
include note-taking, effective
reading strategies, and tips for
time management.
Equal dose and duration with
Shamiri intervention.
27
Delivery
High school graduates trained
as lay provider (“group
leader”). One group leader
will be assigned to each
group of 10-12 youths.
High school graduates trained
as lay provider (“group
leader”). One group leader
will be assigned to each
group of 10-12 youths.
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 28

Table 2

Program feedback scale. Items rated on a 1 (“strongly disagree”) to 5 (“strongly agree”)

scale unless otherwise specified.

I enjoyed/liked participating in the program

The program as whole was helpful

The material in this program was easy to understand

The homework activities were helpful

I liked my group leader

My group leader was helpful

I agree with this program’s message

What lesson did you find most useful?

If in Shamiri intervention group, options are A) growth-mindset, B) gratitude, V) value –
affirmations, and if in study-skills control group, options are A) note-taking, B) effective
reading strategies, C) tips for time management

What lesson did you find least useful?

If in Shamiri intervention group, options are A) growth-mindset, B) gratitude, V) value –
affirmations, and if in study-skills control group, options are A) note-taking, B) effective
reading strategies, C) tips for time management

What was your favorite thing about the program? (free response)

What do you think we can change to improve the program? (free response)
PROTOCOL FOR SHAMIRI GROUP INTERVENTION 29

Figure 1: Participant flowchart.PHQ-8 stands for the Patient Health Questionnaire screener, GAD-7
stands for the Generalized Anxiety Disorder-7 Screener