Sibling-Support for Adolescent Girls (SSAGE)

Not Applicable

Active, not recruiting

Conditions: Anxiety
Mental Illness
Depression

Registration Number: NCT06078124

Lead Sponsor: Washington University School of Medicine

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 180

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom	Up to 2 weeks following the end of the 12 week intervention	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.
Revised Children's Anxiety and Depression Scale (RCADS)-25	Up to 2 weeks following the end of the 12 week intervention	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.

Secondary Outcome Measures

Name	Time	Method
Family Attachment and Changeability Index (FACI-8) (Modified)	Up to 2 weeks following the end of the 12 week intervention	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.
Rosenberg Self-Esteem Scale	Up to 2 weeks following the end of the 12 week intervention	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.
Kidcope	A stressor that occurred in the last two weeks; measurement taken up to 2 weeks following the end of the 12 week intervention	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.