Trial Outcomes & Findings for Sibling-Support for Adolescent Girls (SSAGE) (NCT NCT06078124)
NCT ID: NCT06078124
Last Updated: 2025-11-21
Results Overview
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.
COMPLETED
NA
186 participants
Up to 2 weeks following the end of the 12 week intervention
2025-11-21
Participant Flow
Participant milestones
| Measure |
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.
Although multiple family members may participate in the program, the study only enrolls adolescent girls. Family members are not part of the study and data are only collected from adolescent girls.
|
Control Arm
Care as usual
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
93
|
|
Overall Study
COMPLETED
|
79
|
79
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
| Measure |
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.
Although multiple family members may participate in the program, the study only enrolls adolescent girls. Family members are not part of the study and data are only collected from adolescent girls.
|
Control Arm
Care as usual
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
14
|
Baseline Characteristics
Sibling-Support for Adolescent Girls (SSAGE)
Baseline characteristics by cohort
| Measure |
Sibling Support for Adolescent Girls in Emergencies (SSAGE)
n=93 Participants
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.
|
Control Arm
n=93 Participants
Care as usual
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.84 years
STANDARD_DEVIATION 1.96 • n=68 Participants
|
15.82 years
STANDARD_DEVIATION 1.79 • n=76 Participants
|
15.83 years
STANDARD_DEVIATION 1.87 • n=48 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=68 Participants
|
93 Participants
n=76 Participants
|
186 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
93 Participants
n=68 Participants
|
93 Participants
n=76 Participants
|
186 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
93 Participants
n=68 Participants
|
93 Participants
n=76 Participants
|
186 Participants
n=48 Participants
|
|
Region of Enrollment
Colombia
|
93 Participants
n=68 Participants
|
93 Participants
n=76 Participants
|
186 Participants
n=48 Participants
|
|
Nationality
Colombian
|
9 Participants
n=68 Participants
|
7 Participants
n=76 Participants
|
16 Participants
n=48 Participants
|
|
Nationality
Venezuelan
|
84 Participants
n=68 Participants
|
86 Participants
n=76 Participants
|
170 Participants
n=48 Participants
|
|
Currently in school
|
77 Participants
n=68 Participants
|
76 Participants
n=76 Participants
|
153 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following the end of the 12 week interventionPopulation: Outcomes for the 158 adolescent girls measured at endline. All girls are 13-19 years old and are forcibly displaced.
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.
Outcome measures
| Measure |
Sibling Support for Adolescent Girls in Emergencies (SSAGE)
n=79 Participants
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.
Although multiple family members may participate in the program, the study only enrolls adolescent girls. Family members are not part of the study and data are only collected from adolescent girls.
|
Control Arm
n=79 Participants
Care as usual
|
|---|---|---|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Sleep problems
|
24 Participants
|
28 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Somatic symptoms
|
44 Participants
|
42 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Inattention
|
50 Participants
|
41 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Depression
|
39 Participants
|
43 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Anger/irritability
|
38 Participants
|
40 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Mania
|
31 Participants
|
22 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Anxiety
|
38 Participants
|
40 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Psychosis
|
22 Participants
|
18 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
repetitive thoughts and behaviors
|
57 Participants
|
47 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Substance use
|
21 Participants
|
17 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
Suicide ideation/attempts
|
31 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following the end of the 12 week interventionPopulation: 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.
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.
Outcome measures
| Measure |
Sibling Support for Adolescent Girls in Emergencies (SSAGE)
n=79 Participants
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.
Although multiple family members may participate in the program, the study only enrolls adolescent girls. Family members are not part of the study and data are only collected from adolescent girls.
|
Control Arm
n=79 Participants
Care as usual
|
|---|---|---|
|
Revised Children's Anxiety and Depression Scale (RCADS)-25
Normal range
|
58 Participants
|
61 Participants
|
|
Revised Children's Anxiety and Depression Scale (RCADS)-25
Borderline clinical
|
6 Participants
|
4 Participants
|
|
Revised Children's Anxiety and Depression Scale (RCADS)-25
Clinical range
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeks following the end of the 12 week interventionPopulation: 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.
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.
Outcome measures
| Measure |
Sibling Support for Adolescent Girls in Emergencies (SSAGE)
n=79 Participants
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.
Although multiple family members may participate in the program, the study only enrolls adolescent girls. Family members are not part of the study and data are only collected from adolescent girls.
|
Control Arm
n=79 Participants
Care as usual
|
|---|---|---|
|
Family Attachment and Changeability Index (FACI-8) (Modified)
Attachment subscale
|
20.23 units on a scale
Standard Deviation 3.17
|
20.67 units on a scale
Standard Deviation 2.94
|
|
Family Attachment and Changeability Index (FACI-8) (Modified)
Changeability subscale
|
11.18 units on a scale
Standard Deviation 2.74
|
11.16 units on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Up to 2 weeks following the end of the 12 week interventionPopulation: 158 adolescent girls who participated in a pilot-RCT of SSAGE. Participants are 13-19 years old and are forcibly displaced within Colombia.
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.
Outcome measures
| Measure |
Sibling Support for Adolescent Girls in Emergencies (SSAGE)
n=79 Participants
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.
Although multiple family members may participate in the program, the study only enrolls adolescent girls. Family members are not part of the study and data are only collected from adolescent girls.
|
Control Arm
n=79 Participants
Care as usual
|
|---|---|---|
|
Rosenberg Self-Esteem Scale
|
30.09 units on a scale
Standard Deviation 3.16
|
29.87 units on a scale
Standard Deviation 3.16
|
SECONDARY outcome
Timeframe: A stressor that occurred in the last two weeks; measurement taken up to 2 weeks following the end of the 12 week interventionPopulation: 13-19 year-old girls, half of whom participated in the SSAGE intervention. All participants are forcibly displaced.
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.
Outcome measures
| Measure |
Sibling Support for Adolescent Girls in Emergencies (SSAGE)
n=79 Participants
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.
Although multiple family members may participate in the program, the study only enrolls adolescent girls. Family members are not part of the study and data are only collected from adolescent girls.
|
Control Arm
n=79 Participants
Care as usual
|
|---|---|---|
|
Kidcope
Thought about som ething else or tried to forget
|
67 Participants
|
64 Participants
|
|
Kidcope
Stayed away from people and kept feelings to self
|
57 Participants
|
66 Participants
|
|
Kidcope
Tried to see bright side of things and/or focus on something good
|
72 Participants
|
75 Participants
|
|
Kidcope
Did something to distract self like watch TV or play a game
|
67 Participants
|
72 Participants
|
|
Kidcope
Handled the situation on own
|
66 Participants
|
65 Participants
|
|
Kidcope
Blamed self for causing problem
|
36 Participants
|
39 Participants
|
|
Kidcope
Blamed someone else for putting through problem
|
27 Participants
|
23 Participants
|
|
Kidcope
Thought of ways to solve problem
|
75 Participants
|
71 Participants
|
|
Kidcope
Tried to solve problem on own
|
67 Participants
|
69 Participants
|
|
Kidcope
Screamed, cried, or hit something
|
37 Participants
|
40 Participants
|
|
Kidcope
Tried to calm down byt talking to self, praying, taking a walk
|
70 Participants
|
73 Participants
|
|
Kidcope
Kept thinking and wishing stressor never happened
|
57 Participants
|
54 Participants
|
|
Kidcope
Kept wishing could change what had happened
|
60 Participants
|
59 Participants
|
|
Kidcope
Turned to family, friends, or other adults to help feel better
|
60 Participants
|
56 Participants
|
|
Kidcope
Just accepted the problem because knew there was nothing to do about it
|
64 Participants
|
60 Participants
|
Adverse Events
Sibling Support for Adolescent Girls in Emergencies (SSAGE)
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place