Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177600
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-12-11
Brief Title:
TransHealthGUIDE Transforming Health for Gender-Diverse Young Adults
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
TransHealthGUIDE Transforming Health for Gender-Diverse Young Adults Using Interventions to Drive Equity
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This is a randomized controlled trial to test the effectiveness of an interactive educational app-based digital intervention that provides knowledge and support to transgender and gender-diverse TGD young adults ages 18-24 years and their caregivers The goal of the study is to examine the effects of exposure to the app on TGD young adult mental health outcomes
Participants will be randomized to an Immediate Arm access to a digital platform plus usual care or a Deferred Arm usual care access to the digital platform at 6 mo Usual care consists of access to published resources and community support organizations if available The list of resources will include contact information for a suicide prevention hotline For each Arm the intervention period will last 6 months followed by 9 months of observation during which access to the intervention is maintained Assessments will be performed every 3 months over the 15 month period to document changes in mental health outcomes and the two groups will be compared
The investigators plan to enroll 500 TGD young adults and their caregivers with at least 50 250 participants to identify as Black Indigenous People of Color BIPOC and 50 125 TGD young adults 125 caregivers to be young adult-caregiver dyads
Ongoing process reassessments will be performed to maximize effectiveness of the intervention including focus groups and in-depth interviews with TGD young adults caregivers and providers as well as analysis of data collected through the digital platform and participant surveys Investigators will account for sociodemographic characteristics such as race and ethnicity age gender identity education status existing mental health conditions and history of suicidal ideation or attempt Data will be analyzed across racial minority groups to ensure that the intervention is effective for all racial minorities if there are discrepancies in effectiveness additional mixed methods evaluation will be performed to identify and address potential causes
Participants will be randomized to an Immediate Arm access to a digital platform plus usual care or a Deferred Arm usual care access to the digital platform at 6 mo Usual care consists of access to published resources and community support organizations if available The list of resources will include contact information for a suicide prevention hotline For each Arm the intervention period will last 6 months followed by 9 months of observation during which access to the intervention is maintained Assessments will be performed every 3 months over the 15 month period to document changes in mental health outcomes and the two groups will be compared
The investigators plan to enroll 500 TGD young adults and their caregivers with at least 50 250 participants to identify as Black Indigenous People of Color BIPOC and 50 125 TGD young adults 125 caregivers to be young adult-caregiver dyads
Ongoing process reassessments will be performed to maximize effectiveness of the intervention including focus groups and in-depth interviews with TGD young adults caregivers and providers as well as analysis of data collected through the digital platform and participant surveys Investigators will account for sociodemographic characteristics such as race and ethnicity age gender identity education status existing mental health conditions and history of suicidal ideation or attempt Data will be analyzed across racial minority groups to ensure that the intervention is effective for all racial minorities if there are discrepancies in effectiveness additional mixed methods evaluation will be performed to identify and address potential causes
Detailed Description:
The investigators anticipate at least 80 retention across 12 mo of follow-up This will allow detection of a reduction in suicidal ideation primary outcome from 40 at baseline to 263 or lower at 12-mo follow-up as well as changes in the rate of psychological distress and anxiety secondary outcome Changes in perceptions of caregiver support and communication will also be assessed as these are key mechanisms by which the study proposes to improve mental health outcomes Data analysis will be performed according to intention to treat
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