Sibling-Support for Adolescent Girls (SSAGE)

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06078124
• Other study ID #: R34MH134078-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: Ilana Seff, DrPH
• Phone: +14074638147
• Email: seff[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: August 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Disorders
• Mental Illness

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	Mercy Corps, National Institutes of Health (NIH), Universidad de Los Andes, Women's Refugee Commission

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom	This measure includes 25 items and assesses the presence and severity of several psychiatric symptom domains including depression, anger, mania, anxiety, somatic symptoms, sleep disturbance, psychosis, obsessive thoughts and behaviors, suicidal thoughts and behaviors, substance use (e.g., alcohol, nicotine, prescription medication, and illicit substance use), inattention and irritability in children and adolescents. Nineteen 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), where higher scores indicate higher frequency of occurrence or greater degree of severity. Questions on suicide ideation, suicide attempts, and substance use are rated on a 2-point scale of yes/no.	Past two weeks
Primary	Revised Children's Anxiety and Depression Scale (RCADS)-25	This scale assesses symptoms of depression and anxiety in children and adolescents using 25 items. Items are scored on a 4-point scale (0-never; 1-sometimes; 3-often; and 4-always). The total score is a sum of all item scores and can range from 0 to 100, with higher scores indicating more frequent/severe symptoms. Two subscales, representing depression and anxiety, can also be calculated. The Depression subscale can range from 0 to 40 and the Anxiety subscale can range from 0 to 60; for both subscales, higher scores indicate greater symptomology.	Past two weeks
Secondary	Family Attachment and Changeability Index (FACI-8)	The FACI8 is a 16-item scale where each item is scored using a 5-point Likert scale of how frequently the event occurs (1-Never; 2-Sometimes; 3-Half of the time; 4-Most of the time; 5-Always). The FACI8 consists of two subscales: Attachment and Changeability. The eight items in the Attachment subscale are reverse coded and then summed to create a final score between 0 and 40, where higher scores reflect greater family attachment. The eight items in the Changeability suubscale are summed to create a final score between 0 to 40, where higher scores reflect greater flexibility of family relationships.	Past two weeks
Secondary	Rosenberg Self-Esteem Scale	The Rosenberg Self-Esteem Scale is a 10-item scale that measures positive and negative feelngs 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.	Past two weeks
Secondary	Kidcope	Kidcope is a 15-item checklist designed to measure cognitive and behavioural coping in children and adolescents. It measures the frequency and efficacy of ten coping strategies, including: problem-solving, distraction, social support, social withdrawal, cognitive restructuring, self-criticism, blaming others, emotional expression, wishful thinking and resignation. Items related to frequency are scored on a 4-point scale (0 = "Not at all" to 3 = "Almost all the time"), and items related to effectiveness are scored on a 5-point scale (0 = "Not at all" to 4 = "Very much"). Higher scores on the healthy and most effective coping behaviors are better.	A stressor that occurred in the last two weeks