Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078124
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-11
First Post:
2023-09-28
Brief Title:
Sibling-Support for Adolescent Girls SSAGE
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Sibling-Support for Adolescent Girls SSAGE A Whole-family Gender Transformative Approach to Preventing Mental Illness Among Forcibly Displaced Adolescent Girls
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 programs 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 programs 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 programs 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None