跳至主要内容
临床试验/NCT06078124
NCT06078124已完成不适用

Sibling-Support for Adolescent Girls (SSAGE): A Whole-family, Gender Transformative Approach to Preventing Mental Illness Among Forcibly Displaced Adolescent Girls

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2024年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
1
主要终点
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Sibling Support for Adolescent Girls in Emergencies (SSAGE)

Experimental

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

干预措施: Sibling Support for Adolescent Girls in Emergencies (Behavioral)

Control arm

No Intervention

Care as usual

结局指标

主要结局

Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom

时间窗: 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

时间窗: 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.

次要结局

  • Family Attachment and Changeability Index (FACI-8) (Modified)(Up to 2 weeks following the end of the 12 week intervention)
  • Rosenberg Self-Esteem Scale(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验