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Sibling-Support for Adolescent Girls (SSAGE)

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The Washington University

Status

Completed

Conditions

Mental Illness
Depression
Anxiety

Treatments

Behavioral: Sibling Support for Adolescent Girls in Emergencies

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06078124
R34MH134078-01

Details and patient eligibility

About

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.

Enrollment

186 patients

Sex

Female

Ages

13 to 19 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

186 participants in 2 patient groups

Sibling Support for Adolescent Girls in Emergencies (SSAGE)
Experimental group
Description:
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
Treatment:
Behavioral: Sibling Support for Adolescent Girls in Emergencies
Control arm
No Intervention group
Description:
Care as usual

Trial documents
3

Trial contacts and locations

1

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Central trial contact

Ilana Seff, DrPH; Arturo Harker Roa, PhD

Data sourced from clinicaltrials.gov

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