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Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
https://doi.org/10.1186/s40814-022-01035-x
STUDY PROTOCOL
4 Steps To My Future (4STMF): protocol
forauniversal school-based pilot andfeasibility
study ofaCBT-based psychoeducational
intervention tosupport psychological
well-being amongstyoung adolescents
intheWestern Cape, South Africa
Bronwynè J. Coetzee1* , Maria E. Loades2 , Suzanne Human1 , Hermine Gericke1 , Helene Loxton1 ,
Gerrit Laning3, Naomi Myburgh1 and Paul Stallard4
Abstract
Background: Mental health problems often emerge during middle childhood and adolescence. In South Africa, and
in the context of high rates of poverty, violence, and adversity, many children are at a considerable risk for developing
mental health problems. Access to and costs of mental health services preclude treatment for most. There is evidence
that universal school-based prevention programmes are effective in well-resourced settings. However, little is known
about the feasibility and acceptability of such programmes in low- and middle-income countries (LMICs), including
South Africa.
Methods: This is a feasibility pilot study of 4 Steps To My Future (4STMF), a Cognitive Behaviour Therapy (CBT) school-
based programme for young adolescents in the Western Cape, South Africa. This eight-session intervention will be
delivered to children in grade 5 (aged 10–13 years approximately) attending two public government-run schools
in the Western Cape, South Africa. We aim to enrol approximately 224 children in grade 5. We will randomise which
school receives the intervention first and the other will be a delayed intervention group. We will train individuals with
a post-graduate degree in psychology to facilitate the programme. We will collect demographic data on participants
as well as data on primary (feasibility measures) and secondary outcomes (mental health and well-being measures).
We will collect data at baseline, post-intervention, and at 1-month follow-up.
Discussion: This pilot study will provide data on the acceptability and feasibility of delivering a universal school-
based prevention programme in South African schools. The study will provide preliminary data to inform the design
of a full-scale randomised controlled trial (RCT) of a universal school-based mental health programme aimed at
preventing mental health problems.
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Open Access
*Correspondence: bronwyne@sun.ac.za
1 Department of Psychology, Stellenbosch University, Stellenbosch, South
Africa
Full list of author information is available at the end of the article
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Page 2 of 13
Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
Background
Globally, at least 1 in 5 children and adolescents experi-
ence mental health problems, and this number is likely
to be even higher in low- and middle-income countries
(LMICs), like South Africa [1], where vulnerable popu-
lations face multiple adversities [2]. In South Africa, the
prevalence of anxiety disorder symptoms amongst chil-
dren and adolescents is reported to be high, ranging from
22 to 25.6% amongst 7–13 years old, in the Western Cape
Province [3]. Normative data from a number of studies
conducted within the same context over the past decade
(for example Burkhardt etal., 2003 [4], 2012 [5]; Muris
etal., 2006 [6], 2008 [7]) consistently confirmed higher
fear and anxiety levels in South African children, com-
pared to their western counterparts. us, even before
the COVID-19 pandemic, children and adolescents in
South Africa were already particularly at risk of develop-
ing mental health problems because they are exposed to
multiple risk factors such as violence, child maltreatment,
living in households affected by HIV/AIDS, and poverty
[1, 8–10]. Furthermore, the COVID-19 pandemic is hav-
ing a profound effect on all aspects of society, including
mental health [11]. Whilst disease containment meas-
ures (DCMs) have been implemented to help reduce
the spread of the virus, such measures have had several
unintended adverse consequences for children and young
people (CYP). For example, learning was disrupted and
social and emotional support was reduced [12–14].
Finding appropriate, cost-effective, and efficient ways
to intervene is a key priority, given the impact of men-
tal health problems both short and long term. In the
short term, we know anxiety and depression impact on
daily functioning, disrupt educational attendance and
attainment, affect social relationships and interfere with
normative development [10, 15–18]. In the long term,
untreated depression is associated with an increased risk
of subsequent depression, interpersonal difficulties, and
suicide in adulthood [19, 20].
ere is convincing evidence, predominantly from
high-income countries (HICs), that psychological treat-
ments, including Cognitive Behaviour erapy (CBT),
are effective in treating anxiety and depression [21–25].
CBT-based programmes for CYP with anxiety have been
widely used in individual and group-based contexts
[26]. ere is emerging evidence of the effectiveness of
CBT-based approaches in these populations in LMICs
[27–35]. Paradoxically, in these countries, there is also
a lack of trained clinicians, particularly in the most
deprived areas, where the vulnerability factors for devel-
oping mental health problems are highest [1, 9, 10]. is
lack of trained clinicians has led to interest in mental
health prevention programmes, but to date, preven-
tive interventions undertaken in LMICs are unfortu-
nately lacking. A recent systematic review conducted by
our team of universal school-based mental health pro-
grammes in LMICs identified 12 studies conducted in
11 different LMICs with children aged 8–19 years of age
[36]. Whilst five studies reported improvement in depres-
sion, and five studies reported improvement in anxi-
ety, overall, there were limited data on the outcomes of
the studies, and only four provided explicit examples of
how the interventions were developed or adapted for the
local context. Also, none of the studies was conducted in
South Africa, and none of the studies involved parents or
caregivers in a direct way.
Whilst nearly 90% of all children live in LMICs, only
10% of randomised trials are undertaken in these coun-
tries, with almost all being psychopharmacological tri-
als [1]. is highlighted the need to develop and evaluate
mental health prevention programmes for children in
LMICs with schools providing a promising context for
their delivery [37].
Formative work thatinformed theintervention
development
e design and adaptation of effective preventive inter-
ventions require community ownership, cultural flex-
ibility, and fit with the delivery context to maximise
effectiveness, appropriate training, and support to
deliver, and relevance and acceptability to stakehold-
ers [1, 29]. e intervention presented in this protocol
is based on extensive formative work by the investiga-
tors. Firstly, this intervention is based on expertise in the
use of CBT, programme development and evaluation,
and experience of delivering preventive interventions in
South African schools. Indeed, previous research by the
investigators has demonstrated that existing evidence-
based CBT-based activities and programmes can success-
fully be adapted to be culturally sensitive and to fit within
the South African context [29–34, 38, 39]. Secondly,
Trial registration: This trial is registered with the Pan African Clinical Trial Registry (https:// pactr. samrc. ac. za/ Trial
Displ ay. aspx? Trial ID= 10881) database, with unique identification number for the registry: PACTR202004803366609.
Registered on 24 April 2020.
Keywords: Anxiety, Depression, Prevention, Universal, School-based, Mental health, CBT-based, Psychoeducational
intervention, Pilot, South Africa
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Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
the intervention is informed by a systematic review by
the investigators referred to earlier [36]. e findings of
the review demonstrated that universal school-based
approaches hold promise for reducing symptoms of anxi-
ety and depression amongst CYP and are better delivered
in group format and when based on principles of CBT.
irdly, the intervention is informed by formative quali-
tative interviews conducted by the investigators with
CYP (grades 5–7), school mental health counsellors,
parents/caregivers, and teachers. ese interviews elic-
ited participant perspectives on what a universal school-
based mental health intervention in this setting should
look like and who should be involved [40]. Lastly, to
adapt the intervention in the context of COVID-19, the
intervention is informed by formative follow-up quali-
tative interviews with CYP (grades 5–7), school mental
health counsellors, parents/caregivers, and teachers.
ese interviews asked participants about the challenges
surrounding COVID-19 and various disease containment
measures [41].
is formative work culminated in the manualised,
psychoeducational CBT-informed intervention, 4 Steps
To My Future (4STMF). e four core steps of the pro-
gramme are based on the principles of CBT and are
designed to enhance self-esteem, promote helpful think-
ing, develop emotional regulation, and empower goal-
focused action. Each of the four core steps is designed
to be delivered over two brief school lessons lasting for
20–25 min per lesson (approximately 3–4 hours in total).
Each lesson includes whole group and individual tasks.
Whilst small group tasks were included in the original
4STMF, we had to adapt these in the light of COVID-19
so as to maintain safe social distancing. Further details on
the programme content and activities are available from
the authors on request. Participating children will be
asked to complete tasks in between lessons to apply the
skills learned in daily life. Classroom posters and some
tangible materials (such as worksheets and notebooks)
will provide personal reminders of the skills learned at
each step. An informational handout will be sent to par-
ents/caregivers after each step to inform them of the key
learning points, what was done in the lessons, and how
they can support this at home.
Feasibility trial objectives
e primary objective of this study is to determine the
acceptability and feasibility of the 4STMF programme.
We will use a mixed methods design utilising quantitative
and qualitative methods. We will determine acceptabil-
ity and feasibility through assessing consent and assent
rates, as well as session and programme completion
rates. Fidelity checklists will be completed by the pro-
gramme facilitators and independent observers for each
lesson. ese fidelity checks will elicit how confident,
prepared, and enthusiastic facilitators appeared whilst
delivering the programme, as well as how well they man-
aged the classroom. Furthermore, the fidelity checklists
will elicit how long it took to deliver a lesson, whether
an activity was delivered or changed, and how confident,
prepared, and enthusiastic the facilitators appeared dur-
ing the delivery of that lesson. Furthermore, teachers will
be asked to complete an evaluation form once the pro-
gramme has been facilitated. Qualitative, semi-structured
exit focus groups will be conducted with CYP following
intervention delivery. We will determine the acceptability
of our assessment measures (completion rates) and will
explore pre- and post-intervention changes to determine
sample size (power) for a future randomised controlled
trial (RCT).
Methods/design
is paper reports on the protocol for the feasibility of a
pilot intervention of the 4STMF programme in accord-
ance with the Standard Protocol Items: Recommenda-
tions for Interventional Trials (SPIRIT) checklist (see
Fig.1).
Trial design
We will conduct a two-arm, randomised, feasibility pilot
trial comparing immediate intervention group (IIG)
delivery of 4STMF to a delayed intervention group (DIG).
e consort diagram of the study design is shown in
Fig.2.
Study setting
We will recruit participants from two public primary
schools in the Western Cape province of South Africa
and in collaboration with a non-governmental organisa-
tion (NGO). e NGO operates onsite within schools in
the Western Cape to improve the social and emotional
well-being of children and promote supportive school
communities. e two schools were randomly chosen
(using computer randomisation) from a list of schools
(N = 21) within which the NGO operates. Both schools
have a staff to learner ratio of approximately 40:1, and
both schools form part of South Africa’s National School
Nutrition Programme [42]. Schools are eligible for fund-
ing for this nutrition programme when most of the chil-
dren come from low socio-economic status families. In
total, each school has approximately 30–34 teachers and
900–1000 pupils.
Characteristics ofparticipants
Participants will be in grade 5 at participating schools
(aged ~ 10–13 years). e intervention will be univer-
sally delivered, i.e. delivered to all participating children
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Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
Fig. 1 Standard Protocol Items: Recommendations for Clinical Trials (SPIRIT) figure—schedule of data collection
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Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
regardless of symptomatology or risk. Given the restric-
tions posed on this research by COVID-19 and given
changes to school scheduling, we pragmatically decided
to target the intervention at one grade, grade 5, only.
ere are approximately 20 eligible children per class
with 6 and 8 classes at our target schools respectively. As
such, whilst there are approximately 280 children eligible
to take part in grade 5 across these 2 schools, we expect
a sample of approximately 224 children to take part in
this study which accounts for a 20% non-participation
rate. We will calculate consent and retention rates at
immediate post-intervention as well as 1-month follow-
up. As per communication received from the Western
Cape Education Department (WCED), no research may
be conducted during the fourth term (October–Decem-
ber 2021) as schools are preparing and finalising syllabi
for examinations. is could then mean that a 1-month
follow-up assessment might not be possible with the chil-
dren in the DIG.
Ethical review andconsent
Ethical approval has been obtained from Stellen-
bosch University’s Research Ethics Committee: Social
Behavioural and Education Research (project number:
9183), and reciprocity has been received from the Psy-
chology Research Ethics Committee (reference number:
19-073) at the University of Bath. e WCED approved
of the study being conducted in the two schools (refer-
ence: 20200214-4483).
All grade 5 children in both schools will be informed
about the intervention and will be given a project infor-
mation sheet to take home. e information sheet will
include an opt-out consent form to be returned if par-
ents/caregivers do not wish their child to be part of the
intervention. In addition, children will also be asked
to complete assent forms prior to completing baseline
assessments. Children whose parents do not agree to
participate or who themselves do not provide assent will
be supervised in a separate classroom. Children will not
be required to provide reasons for not taking part. Once
consent and assent have been received, post-graduate
psychology students will administer the baseline bat-
tery of measures to children one class at a time. e pro-
gramme facilitators will be on standby should children
require individual assistance with the completion of the
measures.
Fig. 2 Consort diagram of the study design for the 4STMF programme
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Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
Procedures
Assessments will be completed at baseline, post-
intervention, and at 1-month follow-up. Measures
will be completed in school, over two or three les-
sons. Researchers with a post-graduate degree in
Psychology will read assessment items out loud as
children individually respond to each question in
their assessment booklet. Participants will have the
option to complete forms in either English or Afri-
kaans. We will provide children with a thank you
gift in the form of a 4STMF wrist band after comple-
tion of the intervention sessions, and the completed
assessment battery.
e language of the programme delivery will be in
the predominant language of each class, either English
or Afrikaans. Programme facilitators will be trained to
deliver the programme fluently in both languages. Class
teachers will be encouraged to attend the lessons deliv-
ered and may be involved in disciplinary processes if
necessary, during the lessons, but will not be expected
to deliver the programme material.
Following completion of the 4 Steps To My Future
(8 lessons) programme, children will complete the
assessment battery, and again at a 1-month follow-up.
On completion of intervention delivery, a subgroup
of participants stratified to include both male and
female participants will be invited to take part in focus
group discussions to share their experiences of the
programme.
Outcome measures
All participants will provide demographic information
at baseline (see Fig.1). e schedule of data collection is
shown in Fig.3.
Feasibility
To determine whether it is feasible to deliver the inter-
vention and assessment measures, we will collect the fol-
lowing feasibility and acceptability outcomes:
(1) Rates of parental opt-out: How many parents/car-
egivers refused consent for their child to take part
in the programme? For this outcome, we will count
the number of consent forms returned from par-
ents. As mentioned, we will use parental opt-out.
As such, parents who sign and return the consent
form will do so indicating that they do not want
their child to take part in the study.
(2) Rates of child assent: How many children declined
to take part in the programme? For this outcome,
we will count the number of assent forms handed
out and then the number of forms returned by
learners invited at baseline. We will provide each
child in grade 5 with an assent form. We will sub-
tract the number handed out from the number of
forms returned.
Fig. 3 Overview of the project timeline. IIG immediate intervention group, DIG delayed intervention group
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Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
(3) Rates of assessment completion: How many partici-
pating children completed assessments at baseline,
post-intervention, and 1-month follow-up? For this
outcome, we will count the number of children who
completed assessments at each time point. We will
subtract the number of completed measures from
the number who provided consent at baseline to
determine how many assessments were not com-
pleted at each time point.
(4) Programme completion: How many groups received
all 8 sessions of 4 Steps To My Future? For this out-
come, observers will document session delivery to
each group/class of learners. Observers will capture
whether a session was delivered in full or not.
(5) Session attendance: How many children attended
each session of the programme? For this outcome,
we will count the number of learners present in
class for each session delivery. We will then obtain
class attendance records from the class teacher to
document which learners (who consented to take
part) were present or absent.
(6) Programme fidelity: How many programme ses-
sions were delivered fully, as intended. For this
outcome, observers will capture on observation
templates whether a session was delivered fully as
intended or not. e observer will be instructed to
note what circumstances interfered with session
delivery as intended.
Acceptability
Acceptability will be determined through exit focus
groups with a sample of young people who par-
ticipated in the programme. Focus groups will be
arranged in a safe place in a private classroom or office
on the school premises. All participating children will
be invited to take part in the exit focus groups. Fol-
lowing parental/caregiver consent as well as assent
from children themselves, approximately three chil-
dren per class will be randomly selected and we will
aim to include both male and female participants.
The exit focus groups will not be conducted by the
programme facilitators, but by independent, trained
post-graduate psychology students or members of the
research team. We intend to conduct at least 1 focus
group in each school with up to 6 children in each
focus group. Focus groups will be guided by a script
which will assess a range of domains including accept-
ability, understanding, relevance, and helpfulness.
Focus group interviews will be audio-recorded with
permission from the children.
Psychological well‑being
We will undertake an exploratory analysis of our psy-
chological measures. e purpose will be to (i) inform
decision-making about which will be our primary out-
come in a subsequent trial and (ii) to inform the power
calculation for a subsequent RCT. e following stand-
ardised psychological measures will be completed at each
assessment.
Symptoms ofdepression andanxiety
We will use the Revised Child Anxiety and Depression
Scale-30 (RCADS-30) [43] to measure symptoms of
depression and anxiety. e 30-item measure asks par-
ticipants to rate their responses on a 4-point Likert scale
from ‘never’ to ‘often’. e measure has good psycho-
metric properties, and amongst a South African sample
of adolescents, the 10-item depression subscale showed
good internal consistency (alpha coefficient = 0.86) [44].
Happiness andwell‑being
We will use the happiness and well-being measure devel-
oped as part of the PACES trial [45]. e 7-item, visual
analogue scale measures happiness about the school,
appearance, family, friends, home, health, and life in
general.
Emotion regulation
We will use the 10-item Emotion Regulation Question-
naire for Children and Adolescents (ERQ-CA [46];) to
measure emotion regulation strategies of cognitive reap-
praisal (6 items) and expressive suppression (4 items).
e measure has sound internal consistency and shows
stability over 12 months.
Bullying
We will use the 2-item Olweus Bully/Victim Question-
naire-Modified [47]. Response options are given on a
5-point rating scale (0 not at all, 1 = once or twice, 2 =
two or three times a month, 3 = about once a week, 4 =
several times a week). e measure has 9 items; however,
we will only use two. We use the two items used as part
of the PACES trial [45] in which children are asked about
how often they have been bullied, and how often they
have taken part in bullying other children.
Self‑esteem
We will use the 10-item Rosenberg self-esteem scale [48].
Rosenberg’s Self-Esteem Scale is the standard measure of
self-esteem in psychological research. e scale provides
a short, straightforward, and convenient method for
measuring global self-esteem. Items are measured on a
4-point rating scale from 1 (strongly agree) to 4 (strongly
disagree).
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Table 1 Components of the 4STMF intervention package
Theoretical framework (intervention) Cognitive behavioural therapy (CBT) based with a focus on psychoeducation, resilience, skills‑
building, and well‑being
Interventionists/delivery agents • Registered counsellors/masters-level psychology students with 1–2 years of research experience and
who attended training on the intervention package; masters-level psychology students with 1–2 years
of research experience who will act as observers and conduct fidelity checks
Structure of intervention package • Eight × 20–25-min sessions, delivered over 4 to 8 weeks (delivered either weekly or twice weekly
depending on fit with school)
Structure of sessions • The programme is split into 4 steps — and each step contains 2 lessons. Participants in the immediate
intervention group (IIG) and the delayed intervention group (DIG) receive the intervention
Step 1 lesson 1 • Introduction to 4STMF (5 min)
• Self-esteem and respect (10 min)
• Remember your strengths (6 min)
• Home task saying my strengths out loud each morning (4 min)
Step 1 lesson 2 • Recap of the previous session (5 min)
• Accept who you are (10 min)
• Be kind to yourself and others (6 min)
• Home task spreading kindness (4 min)
Step 2 lesson 3 • Recap step 1, value who you are (10 min)
• The way you think (10 min)
• Home task recognising my STOP and GO thoughts (5 min)
Step 2 lesson 4 • Recap of the previous session (5 min)
• GO thinking (10 min)
• Home task and identification of GO thoughts (10 min)
Step 3 lesson 5 • Recap step 2, thinking that I can (5 min)
• Recognise how you feel (15 min)
• Home task how I feel (5 min)
Step 3 lesson 6 • Recap of the previous session (5 min)
• Helping yourself to feel better (15 min)
• Home task and practice (5 min)
Step 4 lesson 7 • Recap step 3, and practice relaxation (5 min)
• My goals (15 min)
• Home task my goals (5 min)
Step 4 lesson 8 • Recap of the previous session (5 min)
• Problem solving (15 min)
• Recap and ending (5 min)
4STMF training
Structure and format • Once-off × 6–7 h of facilitator training with lead implementer; either online or in person. The training
takes place over 2 days.
Training content • Training content includes an overview of core components of CBT, an overview of programme devel-
opment, orientation to session content, and role playing of lessons; orientation to measures and fidelity
checks
Characteristics of supervisor(s) • Counselling psychologist registered with the HPCSA with more than 5 years counselling experience
and experience in CBT-based interventions; post-doctoral researcher with more than 5 years of CBT
intervention delivery experience
Structure of supervision and debrieng • Counselling psychologist and post-doctoral researcher meet with intervention implementers in person
or online/telephonic, once after the completion of each step of the programme (so once after two ses-
sions have been delivered). As such 4 × 1-h supervision debriefing sessions
• An hour session of debriefing/supervision which entails reflections on the delivery and adherence and
challenges with delivery and content
• Research group debriefing (core research team and implementers), once-off after the delivery of 8
sessions at each of the schools
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Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
Goal setting
We will use the 5-item goal setting scale [49]. Reliability
analyses yielded an alpha of 0.68 for this scale.
Stressful life events inthepast 7 days
e revised child impact of events scale (CRIES) (at post-
intervention only) [50]. is measure contains a screen-
ing question at the beginning to assess for eligibility for
completing this measure. As such, not all children will
necessarily be eligible to complete this measure in full.
Translation ofmeasures
Each of these measures is available freely in the public
domain for research purposes. ese measures as well as
the programme will be available in both English and Afri-
kaans. All the measures are available in English. Measures
not available in Afrikaans were professionally translated
into Afrikaans and professionally and independently back
translated into English. e translations were checked for
accuracy by first language Afrikaans-speaking members
of the research team (SH, HG, HL, NM).
Randomisation andblinding
Two schools were randomly selected from a list of 21
schools within which the NGO operates. ese two
schools were then randomised to either immediate or
delayed delivery of 4STMF. By the nature of the inter-
vention, neither the participants nor the interventionists
were blind to arm.
Intervention
e intervention will be delivered during the Life Orien-
tation (LO) or Personal and Social Wellbeing (PSW) les-
sons, or at a time deemed most suitable by the respective
school principals and teachers. e LO and PSW lessons
are part of the South African national education cur-
riculum and are aimed at providing children with basic
skills and knowledge regarding health, society, rights and
responsibilities, physical education, and preparation for
the world of work.
Both the immediate intervention group as well as the
delayed intervention group will receive the programme in
a face-to-face whole class delivery format.
e intervention is informed by CBT and throughout
the 8 sessions teaches skills in four main areas. Table1
provides an overview of the components of the pro-
gramme. Firstly, participants are encouraged to develop
their self-esteem through identifying their personal
strengths, accepting who they are, and being kind to
themselves and others. e second introduces children
to their cognitions and the importance of developing
“go” thinking (positive, enabling, and balanced). irdly,
children are encouraged to attend to how they feel and
to positively manage strong unpleasant emotions. Finally,
children are encouraged to identify their future goals,
to break these down into steps, and to learn to prob-
lem solve to address issues that might impede their
attainment.
e intervention will be delivered by 2 trained facilita-
tors. It is designed to be active and engaging and uses a mix
of whole group exercises, individual exercises, and different
formats (speech, writing, reading of stories, role play, hand
gestures, andvisual posters). After each session, children
will be asked to undertake a home assignment to transfer
the skills learned in the classroom to their everyday life.
Intervention facilitators’ training andsupervision
Intervention facilitators will have at least an undergradu-
ate degree in psychology or social sciences and will attend
a 2-day training workshop covering the theoretical under-
pinnings of CBT, specific training on the format, content
and delivery of the programme, and procedures for moni-
toring and evaluation. Both facilitators will be assisted by
post-graduate psychology students and/or school mental
health counsellors from the NGO, who will act as observ-
ers during the facilitation of the lessons. All intervention
facilitators will have attended a 2-day training workshop
covering the theoretical underpinnings of CBT, specific
training on the format, content and delivery of the pro-
gramme, and procedures for monitoring and evaluation.
e training is structured to be a combination of didactic
instruction and skills development through role play and
reflective discussions. For the purposes of fidelity to the
programme and to discuss delivery issues, NM (who has
expertise in teaching and in delivering CBT-based men-
tal health interventions to young children in South Africa)
and/or HL (who is a counselling psychologist and lecturer
with expertise in the development, implementation, and
evaluation of CBT-based anxiety interventions for youth
in South African) and/or BC (a lecturer and researcher in
child mental health and study principal investigator (PI))
and/or ML (who is a clinical psychologist and lecturer
with extensive experience of delivering CBT to children
and young people) will conduct 1 h of supervision with
the lead interventionist and co-facilitator after each step
of the programme has been delivered. As such, the pro-
gramme facilitators will receive 4 h of supervision from
an experienced CBT practitioner during the course of the
programme.
Data analysis
Descriptive statistics will summarise our feasibility out-
comes and demographic data. Quantitative data will be
analysed using SPSS and other statistical software, as
appropriate. Participant characteristics will contain both
continuous and categorical variables. We will use means
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Page 10 of 13
Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
and standard deviations to summarise data collected on
the continuous variables and frequencies and percentages
to summarise data collected on the categorical variables.
An exploratory analysis of the psychological outcomes
will be undertaken. Analysis will involve pre- and post-
comparisons within and between groups exploring base-
line, post-intervention, and 1-month follow-up data.
Qualitative data will be transcribed verbatim and will
be uploaded into ATLAS.ti 9 to be analysed deductively
and/or inductively using both content analysis and the-
matic analysis [51]. Qualitative data will be focus group
data collected from learners on completion of interven-
tion delivery at both schools.
e findings obtained from our qualitative formative
work were used to inform the development of the inter-
vention material. Similarly, we will integrate both quan-
titative and qualitative data obtained from this feasibility
and acceptability pilot study in our reporting of the main
study outcomes. We will do so by providing descrip-
tive data on our feasibility outcomes and complement-
ing these numerical data with qualitative data obtained
from our exit interviews. ese exit interviews may then
help us to understand qualitatively, for example, why the
intended number of sessions was not completed.
Discussion
ere is an urgent need for mental health programmes
to focus on CYP in resource-limited settings. is study
will be the first to explore the acceptability and feasibil-
ity of a universal CBT-based, school-based mental health
intervention delivered to CYP in two primary schools in
the Western Cape, South Africa. It is designed to assess
questions of acceptability and feasibility in order to
inform a full-scale RCT. Both quantitative and qualitative
data will be used to assess acceptability and feasibility
outcomes. e intervention is designed to be delivered by
individuals with a psychology background within school
settings that have available psychosocial support services
and, if subsequently proven to be effective, could be read-
ily delivered at scale. is protocol was originally con-
ceptualised before the COVID-19 pandemic, and at the
time of this writing, the Western Cape has emerged from
a 3rd wave of the pandemic. Depending on COVID-19,
this protocol may need to be amended in order to accom-
modate any changes (e.g. school closures, social distanc-
ing rules) that may impact on the successful completion
of this study. We have written this protocol for a pilot
study with a particular context and setting in mind. It is
important to consider that any future adaptation of this
intervention within other contexts will need to be care-
fully considered and these adaptations may have implica-
tions on estimated treatment effects.
Abbreviations
CBT: Cognitive Behaviour Therapy; COVID-19: Coronavirus disease 2019; CYP:
Children and young people; DBE: Department of Basic Education; DCMs:
Disease containment measures; DIG: Delayed intervention group; DRD: Divi-
sion for Research Development; ERQ-CA: Emotion Regulation Questionnaire
for Children and Adolescents; HIC: High income countries; IIG: Immediate
intervention group; LMICs: Low- and middle-income countries; LO: Life Orien-
tation; PSW: Personal and Social Wellbeing; RCADS-30: Revised Child Anxiety
and Depression Scale-30; REC: SBER: Research Ethics Committee: Social,
Behavioural and Education Research; RCT : Randomised controlled trial; SPSS:
Statistical Package for the Social Sciences; WCED: Western Cape Education
Department; 4STMF: 4 Steps To My Future.
Acknowledgements
This work was supported by the Wellcome Trust [213987/Z/18/Z].
Data collection and management
We will collect both quantitative and qualitative data as part of this study. The
quantitative data will include data collected on fidelity to the programme as
well as the data collected on the battery of measures administered to children
at each time point. Given that we will collect data from children at multiple time
points and will need to match these data for analysis purposes, we will require
that each child writes their name and surname on the questionnaires handed
out to them. We will administer the questionnaires to children in the form of a
booklet. The booklet will contain a front page that asks for name, surname, and
date. Each child participant will then be assigned a study code. We will use this
code to enter the data into an Excel and SPSS database. We will create two data-
bases — one containing names, surnames, and study codes and one containing
only the assigned study codes (anonymised data) and the measures data. The
anonymised data will be used for analysis purposes and will be shared securely
with members of the study team and as required by our funders.
Qualitative data will be in the form of audio recordings and verbatim
transcripts. The transcripts will be transcribed verbatim and translated from
Afrikaans into English where necessary. The transcripts will be anonymised
for context and interviewee — as such we will refer to speakers as interview-
ers and participants in the transcripts. As such, interview transcripts will be
anonymised completely, and the documents password protected before
sharing amongst members of the team.
Participants will be allowed to withdraw from the study at the point of consent
and during the study. However, at the point of data anonymisation and analysis,
it will no longer be possible to withdraw participants from the study. All data
will be stored on the password-protected laptops of the research team and data
will be shared safely and securely with only members of the research team. We
will draw up a data transfer/collaboration agreement between Stellenbosch
University and the University of Bath, to ensure the safe sharing of the data.
The Division for Research Development (DRD) and the Division for Institutional
Governance, and the counterparts at the University of Bath, will oversee the data
transfer agreement. Following completion of the study, we will archive the data
for the time period requested by Stellenbosch University, which is a minimum of
5–10 years. We will also ensure that data are prepared and shared in keeping with
the rules and regulations of the Wellcome Trust, the funder.
Data monitoring
HarmsIt is unlikely that young people participating in this programme will
experience any distress as a result of their involvement. As such, we deem this
a ‘low risk’ study. However, by South African guidelines, minors (under 18 years)
participating in research are classified as a vulnerable group and this escalates the
study to medium risk. For a medium-risk study, a risk mitigation plan is needed
in the event of harm or distress. Any children who experience discomfort or
distress as a result of participation in this study will be referred to the services of
our collaborating NGO and these mechanisms of referral are now well in place.
The details are also provided on the respective consent and assent forms. We
do not expect any children to become distressed as a result of participation in
this programme. The programme is positively orientated to assist children with
gaining life skills necessary to cope with everyday stressors. The programme is
provided to all children (i.e. universal) and does not at any point require that chil-
dren disclose any personal information. Children who may become distressed as
a result of participation in the programme will be referred to the lead programme
facilitator (SH), a registered counsellor, or a school mental health counsellor, who
will then refer the learner to a counsellor at the NGO. Any distress detected by the
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 11 of 13
Coetzeeetal. Pilot and Feasibility Studies (2022) 8:99
lead facilitator or co-facilitator(s) which may not be as a result of the programme
but detected during delivery of the programme will be dealt with in the same
way. All adverse events will be reported to the REC: SBER within 7 days of occur-
ring as is stipulated in the standard operating procedures.
Audit
Data will be entered as they are collected by research assistants. At least 10%
of the data collected at each time point will be checked by members of the
research team for accuracy and completion.
Ancillary and post‑intervention care
Both schools have been specifically selected as sites due to the presence of an
NGO who can provide counselling support to those children referred to them
during the course of the study.
Dissemination policy
We hope that this study will establish the viability of a culturally sensitive,
practical, user-friendly, and structured universal intervention deliverable
by NGO staff during school time. We therefore hope this would inform an
application for a definitive RCT. We will disseminate the findings to the school
principals and teachers, parents, and young people via organised seminars
and handouts. We anticipate at least 3 peer-reviewed publications arising from
this study, including a published study protocol, a main outcomes paper, and
a paper undertaking psychometric analysis of the questionnaires used. We
also will aim to present the findings at 2–3 international conferences.
Trial status
On 24 April 2020, following approval from the Research Ethics Committee:
Social, Behavioural and Education Research (REC: SBER), Stellenbosch University
(project ID 9183), this project was registered on the Pan African Clinical Trial
Registry (www. pactr. org) database, with a unique identification number for the
registry: PACTR202004803366609. In light of the COVID-19 pandemic and disease
containment measures (DCMs), such as school closures, put in place by the
South African government, including the Department of Basic Education and the
Western Cape Education Department, as well as guidelines set out by the REC:
SBER, we were unable to deliver the intervention as planned in the year 2020. We
have since received approval to deliver the intervention this year (2021).
Authors’ contributions
BC, ML, PS, SH, HG, and GL made substantial contributions to the original concep-
tualisation of the study design and contributed to the intervention adaptation and
training. HL and NM contributed to the conceptualisation of the study and offered
input on various iterations of the draft of the protocol. The first draft of the manuscript
was written by BC with substantial inputs from PS and ML. All authors critically revised
the draft. All authors read and approved the final manuscript.
Funding
• This research was funded in whole by the Wellcome Trust [213987/Z/18/Z].
For the purpose of Open Access, the author has applied a Creative Commons
Attribution (CC-BY) public copyright licence to any Author Accepted Manu-
script version arising from this submission.
• Dr Maria Loades is funded by the National Institute for Health Research (NIHR
Doctoral Research Fellowship, DRF-2016-09-021). This is independent research.
The views expressed in this publication are those of the authors(s) and not nec-
essarily those of the NHS, NIHR, or the Department of Health and Social Care.
Availability of data and materials
The datasets used and/or analysed during the current study will be made
available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
Ethical approval has been obtained from Stellenbosch University’s REC: SBER
(project number: 9183), and reciprocity has been received from the Psychol-
ogy Research Ethics Committee (reference number: 19-073) at the University
of Bath. The WCED approved of the study being conducted in the two schools
(reference: 20200214-4483).
Children returned to school in February 2021. Parents/caregivers of eligible
children received written information about the study (via a letter sent home with
their children). Two members of the research team (SH; HG) went to the respective
schools in March and April to inform the grade 5 children about 4STMF and to
hand out parental information letters and opt-out return slips for them to give
to their parents. The information leaflet explained that 4STMF is a skills-based,
non-therapeutic programme developed by researchers at Stellenbosch University
and the University of Bath, which has also been approved by the respective school
principals and the WCED to be delivered once a week during LO classes (or at a
time deemed most suitable by the respective school principals and teachers) to
grade 5 children. This information leaflet contains a return slip. Parents will be able
to opt their children out of the study by return slip. The study team will check to
make sure that those parents, who might return slips to school, understand that
the form is opt out, rather than opt in. The written information leaflet contains
details of the study and the programme to be undertaken as well as contact
numbers of the school and the study staff to assist with any questions parents
may have. Parents will be informed that the school has agreed for 8 sessions of
this skills-based programme to be delivered to their children during 1 LO class per
week (or as arranged in correspondence with the respective school principals and
teachers) in the given term with the aim of enhancing self-esteem, promoting
helpful thinking, developing emotional regulation, and empowering goal-focused
action. Parents have been informed that the programme delivery has been
approved by the school principal, teachers, and the WCED.
Parents who opt out (by returning the slip) will be informed that their children
will be allowed to participate during the sessions delivered in class time but
will not take part in the assessment sessions where baseline and follow-up
data on the outcome measures will be collected. It may be very difficult to
exclude children whose parents have opted them out from the programme
completely. However, in instances where parents insist their child not take
part in any of the lessons at all, these children will be supervised by additional
members of the research team (psychology students) or school staff in the
school library area (or venue provided by the school) for the duration of the
lessons. All children will provide written assent ahead of their completion of
the battery of measures. Dual parental consent and child assent are required
for participation in the completion of measures.
For all participants, participation will be entirely voluntary, and no coercion
will take place. Participants will be carefully monitored by the relevant
research team members to detect behaviour that may indicate the participant
is no longer interested in taking part (such as refusal to co-operate). Partici-
pants will be free to withdraw from the study at any point during the data
collection process, without any consequences. However, data that has been
anonymised and prepared for analysis during the later stages of this research
will not be able to be withdrawn. We will destroy the information obtained
from participants who choose to withdraw from the study in the early phases
of this research (before analysis). However, we will request from participants
that we keep data collected from them up to the date of withdrawal.
All data will be anonymised. In the case of the interview data, the data will be
anonymised at the point of transcription to maintain confidentiality. Quantita-
tive data from the questionnaire measures will be anonymised at the point of
data entry. All consent forms and front sheets from the questionnaire packs
will be stored in a locked filing cabinet in BC’s office on the campus of Stel-
lenbosch University, Stellenbosch.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Author details
1 Department of Psychology, Stellenbosch University, Stellenbosch, South
Africa. 2 Department of Psychology, University of Bath, Bath, UK. 3 Commu-
nity Keepers, Non-Profit Company, Stellenbosch, South Africa. 4 Department
of Health, University of Bath, Bath, UK.
Received: 20 October 2021 Accepted: 17 March 2022
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