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Sibling-Support for Adolescent Girls (SSAGE)

Primary Purpose

Anxiety, Depression, Mental Illness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sibling Support for Adolescent Girls in Emergencies
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Mental illness, Adolescent girls, Forcibly displaced populations, Randomized-controlled trial, Implementation science, Family functioning, Gender inequity

Eligibility Criteria

13 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Sibling Support for Adolescent Girls in Emergencies (SSAGE)

    Control arm

    Arm Description

    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

    Care as usual

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    October 5, 2023
    Sponsor
    Washington University School of Medicine
    Collaborators
    Universidad de Los Andes, Women's Refugee Commission, National Institutes of Health (NIH), Mercy Corps
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06078124
    Brief Title
    Sibling-Support for Adolescent Girls (SSAGE)
    Official Title
    Sibling-Support for Adolescent Girls (SSAGE): A Whole-family, Gender Transformative Approach to Preventing Mental Illness Among Forcibly Displaced Adolescent Girls
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2024 (Anticipated)
    Primary Completion Date
    April 30, 2025 (Anticipated)
    Study Completion Date
    August 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine
    Collaborators
    Universidad de Los Andes, Women's Refugee Commission, National Institutes of Health (NIH), Mercy Corps

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Depression, Mental Illness
    Keywords
    Mental illness, Adolescent girls, Forcibly displaced populations, Randomized-controlled trial, Implementation science, Family functioning, Gender inequity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A hybrid type 1 effectiveness-implementation pilot randomized-controlled trial with one treatment arm and one control arm.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sibling Support for Adolescent Girls in Emergencies (SSAGE)
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    Care as usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sibling Support for Adolescent Girls in Emergencies
    Other Intervention Name(s)
    SSAGE
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
    Description
    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.
    Time Frame
    Past two weeks
    Title
    Revised Children's Anxiety and Depression Scale (RCADS)-25
    Description
    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.
    Time Frame
    Past two weeks
    Secondary Outcome Measure Information:
    Title
    Family Attachment and Changeability Index (FACI-8)
    Description
    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.
    Time Frame
    Past two weeks
    Title
    Rosenberg Self-Esteem Scale
    Description
    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.
    Time Frame
    Past two weeks
    Title
    Kidcope
    Description
    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.
    Time Frame
    A stressor that occurred in the last two weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ilana Seff, DrPH
    Phone
    +14074638147
    Email
    seff@wustl.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arturo Harker Roa, PhD
    Phone
    +573107551902
    Email
    a.harker@uniandes.edu.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lindsay Stark, DrPH
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

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    Sibling-Support for Adolescent Girls (SSAGE)

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