Sibling-Support for Adolescent Girls (SSAGE)

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: Completed
• Conditions: Depression; Anxiety; Mental Illness
• Intervention / Treatment: Behavioral: Sibling Support for Adolescent Girls in Emergencies

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • Los Andes University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom	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	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

Outcome Measure	Measure Description	Time Frame
Family Attachment and Changeability Index (FACI-8) (Modified)	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	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	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

• Sponsor: Washington University School of Medicine
• Collaborators: National Institutes of Health (NIH); Mercy Corps; Women's Refugee Commission; Universidad de Los Andes
• Investigators: Principal Investigator: Lindsay Stark, DrPH, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent girls; Family functioning; Implementation science; Randomized-controlled trial; Mental illness; Forcibly displaced populations; Gender inequity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Mental Disorders; Organization and Administration; Health Services Administration; Health Services; Health Care Facilities Workforce and Services; Hospital Administration; Health Facility Administration; Health Facilities; Emergency Medical Services; Hospital Departments; Emergency Service, Hospital
• Other Study ID 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