Clinical trial NCT06078124: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Mental Illness
Keywords: Mental illness
Adolescent girls
Forcibly displaced populations
Randomized-controlled trial
Implementation science
Family functioning
Gender inequity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Universidad de Los Andes
name: Women's Refugee Commission
name: National Institutes of Health (NIH)
name: Mercy Corps
First posted: 2023-10-11
Enrollment: 186
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A hybrid type 1 effectiveness-implementation pilot randomized-controlled trial with one treatment arm and one control arm.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom
timeFrame: Past two weeks
measure: Revised Children's Anxiety and Depression Scale (RCADS)-25
timeFrame: Past two weeks
Secondary outcomes:
measure: Family Attachment and Changeability Index (FACI-8)
timeFrame: Past two weeks
measure: Rosenberg Self-Esteem Scale
timeFrame: Past two weeks
measure: Kidcope
timeFrame: A stressor that occurred in the last two weeks
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Los Andes University
Study officials:
affiliation: Washington University School of Medicine
name: Lindsay Stark, DrPH
role: PRINCIPAL_INVESTIGATOR
References: