Sibling-Support for Adolescent Girls (SSAGE)

November 14, 2025 updated by: Washington University School of Medicine

Sibling-Support for Adolescent Girls (SSAGE): A Whole-family, Gender Transformative Approach to Preventing Mental Illness Among Forcibly Displaced Adolescent Girls

Forcibly displaced adolescents face 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. Therefore, the investigators propose to 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 proposed R34 study will adapt the SSAGE curriculum through human-centered design with a range of stakeholders, including Venezuelan refugees, Colombian returnees and relevant civil society organizations. The proposed study will then 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, the investigators 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. The investigators 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ilana Seff, DrPH
  • Phone Number: +14074638147
  • Email: seff@wustl.edu

Study Contact Backup

Study Locations

  • Colombia
      • Bogotá, Colombia
        • Los Andes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • Are available to participate in survey questionnaires immediately before and one month after the intervention

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sibling Support for Adolescent Girls in Emergencies (SSAGE)
Participants in this arm will participate in the Sibling Support for Adolescent Girls in Emergencies (SSAGE) intervention, along with three family members, for twelve weeks
Behavioral: Sibling Support for Adolescent Girls in Emergencies
The Sibling Support for Adolescent Girls in Emergencies (SSAGE) intervention is a gender-transformative, 12-week program utilizing a "whole family approach" wherein an adolescent girl, her male sibling, and a male and female caregiver participate in sessions that are age- and gender-specific and combined with family-wide discussions of session learnings. The sessions are interactive, engaging, and promote self-reflection and discussion on topics such as power, gender, interpersonal communication, and healthy relationships. Given the whole-family approach, SSAGE addresses intersections between spousal relationships, caregiver-child relationships, and relationships between siblings, as they pertain to supporting the mental health and psychosocial well-being of adolescent girls.
Other Names:
  • SSAGE
No Intervention: Control arm
Care as usual

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Time Frame: Up to 2 weeks following the end of the 12 week intervention
This measure initially includes 25 items and assesses the presence and severity of several psychiatric symptom domains in children and adolescents over the last two weeks. 19 of the items are rated on a 5-point scale (0=none/never; 1=slight/rare; 2=mild/several days; 3=moderate/more than half the days; and 4=severe/almost daily). Questions on suicide ideation, suicide attempts, and substance use are rated on a 2-point scale of yes/no. The included symptoms represent 12 domains of mental disorders: somatic symptoms, sleep problems, inattention, depression, anger/irritability (measured together), mania, anxiety, psychosis, repetitive thoughts and behaviors, substance use, and suicide ideation/attempts. Generally, a respondent is flagged as requiring further inquiry for a given domain if they answered '2' or higher on at least one of the symptoms in each respective domain. As such, this outcome is operationalized as 12 dichotomous variables reflecting the 12 domains.
Up to 2 weeks following the end of the 12 week intervention
Revised Children's Anxiety and Depression Scale (RCADS)-25
Time Frame: Up to 2 weeks following the end of the 12 week intervention
This scale assesses symptoms of depression and anxiety over the past two weeks in children and adolescents using 25 items. Items are scored on a 4-point scale (0-never; 1-sometimes; 2-often; and 3-always) for the last two weeks. The sum of all item scores are then converted into t-scores based on gender and age. Ranges are as follows: t-score<65 is normal range; >=65 and <=69 is borderline clinical; and >=70 is clinical range.
Up to 2 weeks following the end of the 12 week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Family Attachment and Changeability Index (FACI-8) (Modified)
Time Frame: Up to 2 weeks following the end of the 12 week intervention
We employed a modified version of the FACI8. The FACI8 is traditionally a 16-item scale where each item is scored using a 4-point Likert scale of how frequently the event occurs in the last 2 weeks (1-Never; 2-Sometimes; 3-Most of the time; 4-Always). During baseline training, it was determined that four of the items in the traditional FACI8 were not reliable or valid in our study setting. As such, a 12-item version was employed. The modified FACI8 consists of two subscales: Attachment and Changeability. The attachment subscale includes 7 items and the changeability subscale comprises 5 items. Subscale scores are created by summing the relevant item responses. Unfortunately, there was a tech issue with one of the changeability items at endline and data were not collected for that item. As such, we removed that item from the changeability subscale to preserve comparability with baseline. The final score for attachment can be 7-28 and changeability from 4-16. Higher scores are better.
Up to 2 weeks following the end of the 12 week intervention
Rosenberg Self-Esteem Scale
Time Frame: Up to 2 weeks following the end of the 12 week intervention
The Rosenberg Self-Esteem Scale is a 10-item scale that measures positive and negative feelings about the self to create a measure of overall self-worth. Items are scored using a 4-point Likert scale signaling level of agreement with each statement, from strongly agree to strongly disagree. Five items are reverse coded. The final score can take a value from 10 to 40, with higher scores indicating greater self-esteem. The scale asks about the last two weeks and the measure was taken up to 2 weeks following the end of the 12 week intervention.
Up to 2 weeks following the end of the 12 week intervention
Kidcope
Time Frame: A stressor that occurred in the last two weeks; measurement taken up to 2 weeks following the end of the 12 week intervention
Kidcope is a 15-item checklist designed to measure cognitive and behavioural coping in children and adolescents. It measures the frequency of 15 coping strategies, including: problem-solving, distraction, social support, social withdrawal, cognitive restructuring, self-criticism, blaming others, emotional expression, wishful thinking and resignation. Items rare scored on a 4-point scale (0 = "Not at all" to 3 = "Almost all the time"). The final measure is operationalized as 15 dichotomous indicators, where a '1' signals the participant used that coping strategy at least sometimes in the last two weeks for a stressor and a '0' means the participant never used the coping mechanism in the last two weeks.
A stressor that occurred in the last two weeks; measurement taken up to 2 weeks following the end of the 12 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
Mercy Corps
Women's Refugee Commission
Universidad de Los Andes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lindsay Stark, DrPH, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH134078-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified questionnaire data will be shared beginning 3 months and ending 5 years following article publication with qualified researchers who have a research question appropriate to the data and of potential benefit to forcibly displaced adolescent girls. Deidentified data will only be provided in aggregate after completion of a data use agreement. Requests should be directed to lindsaystark@wustl.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Qualified researchers who have a research question appropriate to the data and of potential benefit to forcibly displaced adolescent girls will be granted access to the data. Requests should be directed to lindsaystark@wustl.edu. Deidentified data will only be provided in aggregate after completion of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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