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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06078124
Enrollment
186
Registered
2023-10-11
Start date
2024-08-05
Completion date
2025-06-30
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Mental Illness

Keywords

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

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.

Interventions

BEHAVIORALSibling 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.

Sponsors

Universidad de Los Andes
CollaboratorUNKNOWN
Women's Refugee Commission
CollaboratorUNKNOWN
National Institutes of Health (NIH)
CollaboratorNIH
Mercy Corps
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomUp to 2 weeks following the end of the 12 week interventionThis 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.
Revised Children's Anxiety and Depression Scale (RCADS)-25Up to 2 weeks following the end of the 12 week interventionThis 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.

Secondary

MeasureTime frameDescription
Family Attachment and Changeability Index (FACI-8) (Modified)Up to 2 weeks following the end of the 12 week interventionWe 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.
Rosenberg Self-Esteem ScaleUp to 2 weeks following the end of the 12 week interventionThe 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.
KidcopeA stressor that occurred in the last two weeks; measurement taken up to 2 weeks following the end of the 12 week interventionKidcope 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.

Countries

Colombia

Participant flow

Participants by arm

ArmCount
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 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.
93
Control Arm
Care as usual
93
Total186

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1414

Baseline characteristics

CharacteristicSibling Support for Adolescent Girls in Emergencies (SSAGE)TotalControl Arm
Age, Continuous15.84 years
STANDARD_DEVIATION 1.96
15.83 years
STANDARD_DEVIATION 1.87
15.82 years
STANDARD_DEVIATION 1.79
Currently in school77 Participants153 Participants76 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
93 Participants186 Participants93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Nationality
Colombian
9 Participants16 Participants7 Participants
Nationality
Venezuelan
84 Participants170 Participants86 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
93 Participants186 Participants93 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Colombia
93 Participants186 Participants93 Participants
Sex: Female, Male
Female
93 Participants186 Participants93 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 930 / 93
other
Total, other adverse events
0 / 930 / 93
serious
Total, serious adverse events
0 / 930 / 93

Outcome results

Primary

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.

Time frame: Up to 2 weeks following the end of the 12 week intervention

Population: Outcomes for the 158 adolescent girls measured at endline. All girls are 13-19 years old and are forcibly displaced.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSomatic symptoms44 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomAnger/irritability38 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomMania31 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSleep problems24 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomAnxiety38 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomPsychosis22 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptomrepetitive thoughts and behaviors57 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSubstance use21 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomInattention50 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSuicide ideation/attempts31 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomDepression39 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSuicide ideation/attempts30 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomPsychosis18 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptomrepetitive thoughts and behaviors47 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSomatic symptoms42 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSleep problems28 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomDepression43 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomAnger/irritability40 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomMania22 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomAnxiety40 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomSubstance use17 Participants
Control ArmDiagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting SymptomInattention41 Participants
Primary

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.

Time frame: Up to 2 weeks following the end of the 12 week intervention

Population: Participants are forcibly displaced adolescent girls ages 13-19 years old. Measures were taken at endline (post-intervention) for 79 treatment and 79 control participants.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Revised Children's Anxiety and Depression Scale (RCADS)-25Normal range58 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Revised Children's Anxiety and Depression Scale (RCADS)-25Borderline clinical6 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Revised Children's Anxiety and Depression Scale (RCADS)-25Clinical range15 Participants
Control ArmRevised Children's Anxiety and Depression Scale (RCADS)-25Clinical range14 Participants
Control ArmRevised Children's Anxiety and Depression Scale (RCADS)-25Normal range61 Participants
Control ArmRevised Children's Anxiety and Depression Scale (RCADS)-25Borderline clinical4 Participants
Secondary

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.

Time frame: Up to 2 weeks following the end of the 12 week intervention

Population: Note to ClinicalTrials.gov: Unfortunately, this scale was not found to be valid or reliable with our study population and we therefore did conduct any analysis with this measure. As such, we do not feel it is appropriate for others to derive any conclusions from the results for these measures.

ArmMeasureGroupValue (MEAN)Dispersion
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Family Attachment and Changeability Index (FACI-8) (Modified)Attachment subscale20.23 units on a scaleStandard Deviation 3.17
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Family Attachment and Changeability Index (FACI-8) (Modified)Changeability subscale11.18 units on a scaleStandard Deviation 2.74
Control ArmFamily Attachment and Changeability Index (FACI-8) (Modified)Attachment subscale20.67 units on a scaleStandard Deviation 2.94
Control ArmFamily Attachment and Changeability Index (FACI-8) (Modified)Changeability subscale11.16 units on a scaleStandard Deviation 2.66
Secondary

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.

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

Population: 13-19 year-old girls, half of whom participated in the SSAGE intervention. All participants are forcibly displaced.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeHandled the situation on own66 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeThought of ways to solve problem75 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeTried to solve problem on own67 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeBlamed self for causing problem36 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeScreamed, cried, or hit something37 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeTried to calm down byt talking to self, praying, taking a walk70 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeTried to see bright side of things and/or focus on something good72 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeKept thinking and wishing stressor never happened57 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeStayed away from people and kept feelings to self57 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeKept wishing could change what had happened60 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeThought about som ething else or tried to forget67 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeTurned to family, friends, or other adults to help feel better60 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeBlamed someone else for putting through problem27 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeJust accepted the problem because knew there was nothing to do about it64 Participants
Sibling Support for Adolescent Girls in Emergencies (SSAGE)KidcopeDid something to distract self like watch TV or play a game67 Participants
Control ArmKidcopeJust accepted the problem because knew there was nothing to do about it60 Participants
Control ArmKidcopeDid something to distract self like watch TV or play a game72 Participants
Control ArmKidcopeThought of ways to solve problem71 Participants
Control ArmKidcopeScreamed, cried, or hit something40 Participants
Control ArmKidcopeThought about som ething else or tried to forget64 Participants
Control ArmKidcopeStayed away from people and kept feelings to self66 Participants
Control ArmKidcopeHandled the situation on own65 Participants
Control ArmKidcopeTried to see bright side of things and/or focus on something good75 Participants
Control ArmKidcopeBlamed self for causing problem39 Participants
Control ArmKidcopeBlamed someone else for putting through problem23 Participants
Control ArmKidcopeTried to solve problem on own69 Participants
Control ArmKidcopeTried to calm down byt talking to self, praying, taking a walk73 Participants
Control ArmKidcopeKept thinking and wishing stressor never happened54 Participants
Control ArmKidcopeKept wishing could change what had happened59 Participants
Control ArmKidcopeTurned to family, friends, or other adults to help feel better56 Participants
Secondary

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.

Time frame: Up to 2 weeks following the end of the 12 week intervention

Population: 158 adolescent girls who participated in a pilot-RCT of SSAGE. Participants are 13-19 years old and are forcibly displaced within Colombia.

ArmMeasureValue (MEAN)Dispersion
Sibling Support for Adolescent Girls in Emergencies (SSAGE)Rosenberg Self-Esteem Scale30.09 units on a scaleStandard Deviation 3.16
Control ArmRosenberg Self-Esteem Scale29.87 units on a scaleStandard Deviation 3.16

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026