Sibling-Support for Adolescent Girls (SSAGE)

NCT06078124 | Completed Results

• 1 other identifier: R34MH134078-01
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression; Mental Illness

Keywords

Mental illness; Adolescent girls; Forcibly displaced populations; Randomized-controlled trial; Implementation science; Family functioning; Gender inequity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Family Attachment and Changeability Index (FACI-8) (Modified)

  Up to 2 weeks following the end of the 12 week intervention

• Rosenberg Self-Esteem Scale

  Up to 2 weeks following the end of the 12 week intervention

• Kidcope

  A stressor that occurred in the last two weeks; measurement taken up to 2 weeks following the end of the 12 week intervention

Study Arms (2)

Sibling Support for Adolescent Girls in Emergencies (SSAGE)

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Care as usual

Interventions

Sibling Support for Adolescent Girls in Emergencies BEHAVIORAL

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.

Also known as: SSAGE

Sibling Support for Adolescent Girls in Emergencies (SSAGE)

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Universidad de Los Andes: collaborator
• Women's Refugee Commission: collaborator
• National Institutes of Health (NIH): collaborator
• Mercy Corps: collaborator

Study Sites (1)

Los Andes University

Bogotá, Colombia

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Mental Disorders

Interventions

Emergency Service, Hospital

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hospital Departments; Hospital Administration; Health Facility Administration; Health Facilities; Health Care Facilities Workforce and Services; Emergency Medical Services; Health Services; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Lindsay Stark
• Organization: Washington University in St. Louis

lindsay.stark@wustl.edu

314-935-4747

Study Officials

• Lindsay Stark, DrPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A hybrid type 1 effectiveness-implementation pilot randomized-controlled trial with one treatment arm and one control arm.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 11, 2023
• Study Start: August 5, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: November 21, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

CO (1)