Sibling-Support for Adolescent Girls (SSAGE): A Whole-family, Gender Transformative Approach to Preventing Mental Illness Among Forcibly Displaced Adolescent Girls
Phase: NA
Conditions: Anxiety, Depression, Mental Illness
Sponsor: Washington University School of Medicine

 
Title: Sibling-Support for Adolescent Girls (SSAGE): A study protocol for a pilot randomized-controlled 
trial of a whole-family, gender transformative approach to preventing mental illness among forcibly 
displaced adolescent girls 
 
NCT number: NCT06078124 
 
Date: July 12, 2024 
 
 
 

Title: 
Sibling-Support for Adolescent Girls (SSAGE): A study protocol for a pilot randomized-controlled trial of a 
whole-family, gender transformative approach to preventing mental illness among forcibly displaced 
adolescent girls 
 
Principal Investigators: 
Ilana Seff, seff@wustl.edu 
Lindsay Stark, lindsaystark@wustl.edu 
 
 
Co-Principal Investigators: 
Arturo Harker Roa, a.harker@uniandes.edu.co 
Byron Powell, bjpowell@wustl.edu 
 
Date and Version: 
July 12, 2024 Version 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Abstract 
 
Forcibly displaced adolescents, especially girls, are at increased risks for mental illness and 
distress, with adolescent girls disproportionately affected in part due to the heightened gender inequity 
that often accompanies forced displacement. Although the family unit has the potential to prevent mental 
illness and promote healthy development in adolescents, few family interventions have employed a 
gender transformative approach or included male siblings in an effort to maximize benefits for adolescent 
girls. 
This study will assess an innovative whole-family and gender transformative intervention—Sibling Support 
for Adolescent Girls in Emergencies (SSAGE)—to prevent mental health disorders among adolescent girls 
in Colombia who were recently and forcibly displaced from Venezuela. The study will employ a hybrid 
type 1 effectiveness-implementation pilot randomized control trial (RCT) to test the program’s 
effectiveness and mechanistic pathways as well as to explore determinants of implementation in order to 
establish the feasibility, acceptability, and fidelity of SSAGE.  
To address these aims, we will enroll 180 recently arrived, forcibly displaced adolescent girls in an 
RCT and examine the program’s effectiveness on the prevention of mental illness (through reduction in 
anxiety, depression, interpersonal sensitivity, and somatization symptoms) one-month post-intervention. 
We will use contextually adapted and piloted measures to collect additional data on the hypothesized 
mechanistic pathways, including family attachment, gender equitable family functioning, self-esteem, and 
coping strategies. The implementation evaluation will employ mixed methods to assess the program’s 
feasibility, acceptability, fidelity and barriers and facilitators to successful implementation. Potential 
findings can support humanitarian program implementation, as well as inform policy to support 
adolescent girls’ mental health and to prevent the myriad disorders that can arise as a result of exposure 
to displacement, conflict, and inequitable gender norms in their households and communities. 
 
Background and Rationale 
 
Forcibly displaced children and adolescents face heightened levels of mental distress and illness 
(1–3). Evidence demonstrates that many experiences surrounding the forced migration process—such as 
exposure to conflict and violence, family loss or separation, and other adverse events—serve as risk 
factors for mental distress among displaced adolescents (2). Adolescent girls face additional gendered 
exposures in humanitarian settings, including intimate partner and non-partner physical and sexual 
violence, early marriage, and sexual exploitation, which may serve to exacerbate mental distress and 
health (2,4). Mental illness among forcibly displaced girls most often manifests through internalizing 
behaviors and symptoms, such as anxiety, depression, and psychosomatic symptomology (2,4,5). 
The mental well-being of adolescent girls may be further impacted by gender inequitable 
attitudes and norms, which are often exacerbated in humanitarian settings (6–8). Previous research from 
low-income country and refugee settings reveals a strong relationship between gender inequitable norms 
at the community level and lowered self-esteem and well-being at the individual level for adolescent girls 
(7,9). Girls who internalize norms that marginalize and devalue their role within the family and 
community, may experience lowered self-esteem, perceived agency and resilience (7,10,11). Inequitable 

household gender norms rooted in patriarchal systems rely not only on strict father-daughter interactions, 
but also on inequitable sibling relationships wherein adolescent male relatives such as brothers or cousins 
engage in disciplining girls for transgressing gender norms (12). Further, fathers and brothers’ strategies 
for keeping girls safe in humanitarian settings often include limiting girls’ mobility, which can erode 
healthy coping and attachment and consequently increase vulnerability to mental health disorders when 
experiencing stressors (13,14). 
Conversely, evidence shows that household environments characterized by high levels of family 
functioning, supportive relationships, and healthy caregiving practices, can promote resilience in children 
and adolescents (3,14,15). For example, family connectedness was found to be inversely associated with 
internalized mental health symptoms among conflict-affected children and adolescents in Chechnya; and, 
in Gaza, supportive parenting practices were linked to reduced symptoms of depression, aggression, and 
other antisocial behavior among adolescents (15–17). As such, family-level interventions have become an 
in increasingly employed approach for bolstering resilience and mental health among adolescents 
affected by conflict or experiencing forced displacement. The majority of literature supporting the utility 
of whole-family interventions in improving adolescent mental health derives from high-income countries, 
though a small body of evidence points to the promise of such interventions in low-income and 
humanitarian settings. A family-level psychosocial intervention implemented in the Democratic Republic 
of Congo, for example, reduce post-traumatic stress symptoms for youth or adolescents who had 
previously been abducted or had a family member who had been abducted (18)(19). However, a recent 
scoping review of whole-family interventions in humanitarian settings found only two programs employed 
a gender-transformative approach, and limited evidence speaks to the impact of no whole-family 
interventions in these settings incorporate gender-transformative approaches and limited evidence 
speaks to the potential  consider gender-transformative considerations of whole-family interventions in 
these settings, nor considers , rigorous evidence is also lacking on effective family-based interventions 
that employ a gender-transformative approach to ensure positive impacts for adolescent girls, in 
particular (20). 
To generate evidence on what works to prevent mental illness among forcibly displaced 
adolescent girls, Washington University in St. Louis, Universidad de Los Andes, Women’s Refugee 
Commission, and Mercy Corps are conducting a hybrid type 1 effectiveness-implementation pilot 
randomized-controlled trial (RCT) of Sibling Support for Adolescent Girls in Emergencies (SSAGE). SSAGE 
is a whole-family and gender-transformative mental health intervention that aims to foster more secure 
family attachments, improve girls’ self-esteem, and strengthen healthy coping skills on the path to 
improved mental health for forcibly displaced adolescent girls. The objectives of this hybrid type 1 pilot 
RCT are twofold. First, the study aims to examine the preliminary effectiveness and mechanistic pathways 
of SSAGE to prevent mental health disorders among recently arrived, forcibly displaced adolescent girls in 
Colombia; and second, the study seeks to assess the feasibility, acceptability and fidelity of the SSAGE 
intervention and identify determinants of successful implementation. 
 
Study objective 
 
● Primary Objective: The study aims to assess the effectiveness of the SSAGE intervention in 
preventing mental health disorders among recently displaced adolescent girls in Colombia, 
particularly focusing on reducing symptoms of anxiety, depression, interpersonal sensitivity, and 
somatization. 

● Secondary Objective: The study seeks to explore the mechanistic pathways through which SSAGE 
operates, including its impact on family attachment, gender equitable family functioning, self-
esteem, and coping strategies. 
● Implementation Evaluation: Additionally, the study will evaluate the feasibility, acceptability, and 
fidelity of implementing SSAGE, including identifying barriers and facilitators to successful 
implementation at endline. 
 
 
 
 
Methodology 
 
We will undertake a hybrid type 1 effectiveness-implementation pilot RCT to test the 
effectiveness and mediators of SSAGE while simultaneously using a concurrent, convergent mixed 
methods design to examine the acceptability, feasibility, and fidelity of the intervention. 
Screening for Eligibility: Inclusion Criteria 
Recruitment for this study will draw from families who fled Venezuela and relocated to Colombia 
within the last year. Included among this population are families originally born in Colombia who had 
previously emigrated to Venezuela for at least five years and subsequently returned to Colombia. 
Eligibility requirements include adolescent girls aged 13-19 years old who: live with a male and female 
caregiver and an adolescent male sibling or relative; immigrated to Colombia within the last year; are 
available, along with their family members, to participate in the SSAGE intervention for three months; and 
are available to participate in survey questionnaires immediately before and one month after the 
intervention (please see Figure 1 for a study schedule). We will recruit 180 adolescent girls from 180 
families. Study participants will be recruited by Mercy Corps and consented and enrolled in the study by 
Los Andes University. 
Figure 1.  Schedule of enrolment, interventions, and assessments 
 
2024 
2025 
TIMEPOINT 
Aug 
Sept 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Allocation 
X 
 
 
 
 
 
 
 
 
 
 
 
 
INTERVENTIONS: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment: SSAGE 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
Control: Care as usual 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
DATA COLLECTION: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline survey data 
collection 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Endline survey data 
collection 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Qualitative data collection 
for implementation 
outcomes 
 
 
 
X 
X 
 
 
 
 
 
 
 
 

DATA ANALYSIS AND 
DISSEMINATION 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
Write-up of findings 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
Subject Recruitment, enrollment, treatment assignment and sample size 
 
Following confirmation of eligibility criteria, the study team will obtain informed parental consent 
and direct assent from potential adolescent girl participants. Every adolescent girl recruited to the study 
will be assigned a unique study identification number to enable tracking survey responses across points 
of data collection. 
 Sample size and power analysis: To detect a medium effect size in our primary outcomes of 
interest of d=0.5, assuming statistical power of 80% and a one-sided alpha of 0.05, we need a sample size 
of 63 adolescent girls in each study arm. We expect approximately 20% attrition from baseline to T2 either 
through: (1) declining to participate in subsequent rounds of data collection or (2) data collectors’ inability 
to locate the participant. Additionally, when estimating the effect of SSAGE on the four outcomes of 
interest, we will exclude adolescent girls already exhibiting above-threshold scores on the four-dimension 
measure of mental health symptoms at baseline as it would not be possible to ‘prevent’ mental health 
disorders in this subgroup.  We expect this to result in the loss of an additional 10% of the initial sample. 
As such, we require a sample size of 90 girls for each study arm. 
 
Following the recruitment of 180 girls from 180 families, 90 adolescent girls each will be 
randomized to the treatment and control arm using a random number generator. Randomization 
will not be blinded. 
 
Consent 
 
Prior to data collection, participants and their caregivers (for those under 18 years of age) 
will be informed about the study's purpose, procedures, potential risks, and safeguards, including 
confidentiality and referrals for services. They'll learn that participation in the SSAGE intervention 
is random but not being selected won't affect access to future programs. Participation is 
voluntary, and participants won't face penalties for declining. They can withdraw at any time and 
refuse to answer questions. Participants will be informed about data usage. Researchers will 
ensure genuine informed consent by providing thorough explanations, multiple opportunities for 
questions, and avoiding coercion. Staff will be trained accordingly. The appendix contains the 
informed consent document that requires participant signature or parent/guardian signature for 
participants under the age of 18 years. 
 
Data Collection 
 

To measure effectiveness of the intervention, all 180 adolescent girls in the study (both 
treatment and control arms) will complete a survey questionnaire through an enumerator-
facilitated interview using computer-assisted personal interview (CAPI) software immediately 
prior to the onset of the intervention. These same participants will be visited one month following 
the completion of the 12-week intervention (T2) to take the same survey using CAPI. The survey 
questionnaire is expected to take approximately 60 to 90 minutes to complete. Study 
participants’ study identification will be used to link their survey responses between baseline and 
T2. 
 
 
Study Outcome Measures and Ascertainment 
 
The primary outcome measures include mental illness, anxiety and depression. A full list 
of primary and secondary outcomes, corresponding sources of measurement, and hypothesized 
directions of change can be found in Table 1. Relevant socio-demographic variables will also be 
collected, including age, education status, caregiver employment status, current living situation 
and household composition, relationship status, time in Colombia, country of birth, stressful life 
events, and other support services being received by the household. Survey tools will be 
translated into Spanish and back-translated. 
Before each participant leaves the data collection site, their data will be reviewed by a 
data collector for completion. All data will be incrementally backed up each day on a secure data 
system and a full back-up will be performed weekly. The research team at Washington University 
in St. Louis will be responsible for weekly data checks to ensure data quality; errors will be 
reported to the local field team and rectified. Only selected, authorized WRC, Mercy Corps, 
University of Los Andes, and Washington University staff will have access to the password-
protected data. 
 
Table 1. Primary and secondary outcomes and hypothesized direction of change 
Construct as presented in 
Figure 1 
Source of measure 
Hypothesized 
direction of change 
Primary outcomes of interest 
Mental illness 
DSM-V cross-cutting youth (35) 
Decrease 
 
Anxiety and depression 
Revised Child Anxiety and Depression 
Scale-25 (36) 
Decrease 
Secondary outcomes/mediators 
Gender equitable family 
functioning 
Gendered responsibilities scale (37) 
Increase 
Family attachment 
Family Attachment and Changeability 
Index (FACI8) (38) 
Increase 

Improved self-esteem 
Rosenberg Self-Esteem Scale (RSES) 
(39) 
Increase 
High instrumental coping skills 
Kidcope (40) 
Increase 
 
Ethical Considerations: 
 
Participants will be fully informed about the research study's ethical guidelines to ensure 
their rights and welfare are protected. Prior to data collection, participants will be asked to 
provide informed consent, ensuring they understand the purpose, procedures, risks, and benefits 
of participation. Furthermore, all research procedures will undergo review and approval by the 
Institutional Review Board to uphold ethical standards. 
 
Risks and Benefits: 
 
Participants will be informed about the potential risks involved in the study, such as 
discomfort or emotional unease when answering personal questions. However, participants will 
be assured that measures will be taken to minimize these risks, including the availability of 
support services if needed. While there may be no direct benefits to individual participants, they 
will be informed that their involvement could contribute valuable insights to benefit communities 
in humanitarian contexts, including Colombia, in the future. 
 
Safety and Adverse Events: 
 
To prioritize participant safety, support services will be readily accessible to participants 
through Mercy Corps and other local resources if they experience any adverse events or 
discomfort during participation. Confidentiality measures will also be implemented to protect 
participant privacy and ensure the security of personal information. Participants will be reassured 
of their right to withdraw from the study at any time without facing any negative consequences. 
 
Data Analysis 
 
Statistical methods 
 
To assess the effectiveness of SSAGE in preventing mental health disorders, we will test the 
null hypothesis that adolescent girls who participate in SSAGE exhibit the same or greater levels 
of mental health symptoms as compared to girls who receive care as usual. We will test this 
hypothesis using both an intent-to-treat and per protocol analytical approach (41,42). We will 
employ generalized linear regression models to estimate the effect of the intervention on the 
primary outcomes, controlling for covariates not balanced between the two study arms at 

baseline; given that treatment assignment is random, we expect that we will not need to control 
for many covariates. Per protocol analysis will also be conducted, leveraging attendance data 
from all participating family members. The threshold for meeting program adherence will be 
defined alongside program implementers prior to program implementation. 
As a secondary, exploratory analysis, we will examine the effect of SSAGE on gender equitable 
family functioning, family attachment, self-esteem and coping strategies (see mechanistic 
pathways in Figure 1); and, we will assess if the effect of SSAGE on each of the primary outcomes 
of interest is mediated by these four secondary measures. The effect of SSAGE on each secondary 
outcome will be assessed using linear regression models (as described above). Mediation analysis 
will be conducted using structural equation modeling to estimate the degree to which each 
secondary measure mediates the impact of SSAGE on the prevention of mental health disorders. 
To avoid a reduction in statistical power and potentially biased results, we will employ iterative 
Monte Carlo Markov Chain (MCMC) multiple imputation to handle missing data in Stata. We will 
first generate 50-100 imputed datasets using expectation-maximization algorithm as estimates 
on which we will employ the MCM procedure. All statistical inferences will then be made using 
the combined results across all complete datasets 
 
Implementation evaluation 
 
Qualitative implementation evaluation data–including key informant interviews with 
program staff and mentors (n=8) (43) and semi-structured in-depth interviews with a subset of 
individuals in the treatment arm (n=24)–will be conducted immediately following the end of the 
intervention to assess program acceptability, feasibility, and fidelity, and to identify 
implementation determinants (i.e., barriers and facilitators) that may influence the quality of 
program delivery.(44,45) Program participants will be purposively sampled in order to ensure 
representation from all cohorts (male caregivers, female caregivers, adolescent boys, and 
adolescent girls) as well as levels of adherence to the treatment protocol including number and 
length of sessions delivered as well as attendance. By also including participants with low 
attendance, we will be able to explore fidelity as well as potential barriers to acceptance and 
feasibility. Program mentors and staff will also be purposively sampled to ensure representation 
across target cohorts and levels of oversight, respectively, in order to inform an exploration of 
implementation determinants.  Interview guides will be guided by the Exploration, Preparation, 
Implementation, and Sustainment (EPIS) Framework(46,47) and Implementation Outcomes 
Framework(48) and will focus on the facilitators of and barriers to program implementation as 
well as the acceptability, feasibility, and fidelity of SSAGE. Interviews will be recorded, translated, 
transcribed, and cleaned for analysis. 
 
SSAGE’s acceptability and feasibility will also be measured through administration of the 
acceptability and feasibility sub-scales of the Mental Health Implementation Science Tools 
(mhIST). These two scales will be administered to all treatment participants (n=90) at T2, as part 

of the quantitative survey.(49) The mhIST was developed specifically for use in low-resource 
settings and the tool has been validated in multiple low- and middle-income countries, including 
in Colombia.(49) Each scale includes 15 questions that are answered by the respondent using a 
Likert scale. 
 
Descriptive statistics for the mhIST items and scales will first be estimated to identify 
perceptions of program acceptability and feasibility. Qualitative data will be imported into a 
qualitative data analysis software and analyzed using qualitative content analysis, a theory-driven 
approach that will involve both deductive and inductive coding.(50,51) Deductive codes will be 
derived from guiding conceptual frameworks.(46,48,52) Mixed methods analyses will involve 
merging the quantitative and qualitative data in joint displays to examine the extent to which the 
two types of data converge. These results will inform further refinements of SSAGE and the 
identification of implementation strategies that may be needed to address identified 
determinants and ensure that the intervention is routinely delivered with high quality. 
 
 
 
Data Handling, Confidentiality and Security  
 
U.S. government representatives, including the Office for Human Research Protections, may 
access records pertaining to this research to fulfill federal or state responsibilities. 
Representatives from the National Institute of Mental Health, the University, and the 
Institutional Review Board (IRB) oversee the conduct of this study. All identifiers will be removed 
from data, which will be stored in a separate locked file cabinet. Once entered into computer 
files, data will be password protected, with access restricted to the research team. Data shared 
with others will be stripped of identifiers and coded for anonymity. This research is covered by a 
Certificate of Confidentiality from the federal U.S. government, allowing researchers to refuse to 
disclose information that may identify participants in legal proceedings or to unauthorized 
individuals. Participants have the right to control the disclosure of their information and 
involvement in the study, including granting permission for the research team to disclose their 
information to third parties. 
 
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