Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04554420 |
Other study ID # |
U54MD007598 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 2024 |
Est. completion date |
June 2024 |
Study information
Verified date |
November 2023 |
Source |
Charles Drew University of Medicine and Science |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The current study addresses the gap in equity in mental health education for adolescents of
color in South Los Angeles. Particularly, the focus is on developing, testing and evaluating
the feasibility and youth responsiveness of a curriculum reflecting the main
principles/concepts of the framework of "Youth Participatory Action Research" and general
mental health outcomes for adolescents living in a context of poverty and significant
inequities.
Description:
In order to effectively prevent mental distress and promote well-being for youth of color in
urban contexts with significant health inequities and mental health stigma, more innovative
and participatory models are critical. Youth participatory action research (YPAR), is a
framework outlining engagement of youth with researchers more equitably as co-constructors of
knowledge and promoting positive development of core competencies in youth to foster their
growth as change agents. YPAR is especially valuable for youth of color, to build
competencies (e.g., critical consciousness, research and advocacy skills) critical for
tackling health inequities and systems change. The proposed study will be conducted in
partnership with the Community Healing and Trauma Prevention Center (CHTPC), a community
grass roots organization of the Los Angeles County Department of Public Health, charged with
designing educational and creative spaces for prevention and healing of trauma in the
community, with youth positive development as one of its key priorities. Guided by YPAR, this
mixed-method, pre-post evaluation study will develop a YPAR-Mental Health (MH) curriculum and
evaluate its feasibility, youth responsiveness, and association with positive youth
developmental outcomes related to YPAR and mental health with youth of color (ages 14-17)
from high schools in South Los Angeles (SPA-6). The study will comprise two phases: Phase 1 -
Development and Refinement of YPAR-MH Curriculum, and Phase 2 - Pilot Testing, Implementation
and Evaluation of YPAR-MH Curriculum. During phase 1, a team of the PI, CDU graduate
students, King/Drew Magnet High School students, and CHTPC staff will develop the curriculum.
Input for refinement of the curriculum will be offered by a team of youth experts, including:
a) community youth advocates, b) clinical psychologist with youth mental health expertise,
and c) community psychologist with YPAR expertise. A set of four focus groups will be
conducted with youth (4-6 youth per focus group, 14-17 years of age) to further improve the
curriculum to assure "youth responsiveness".
During phase 2, a total of 20 youth will participate in the pilot testing of the YPAR-MH
curriculum. After further refining the curriculum given lessons learned from the pilot
testing, a total of 50 youth will participate in the finalized curriculum implementation. A
pre-post curriculum survey will be conducted for all youth. Additionally, a set of four focus
groups with youth participating in the finalized curriculum will be conducted to evaluate
their qualitative experiences, satisfaction with curriculum, and learning of curriculum
material. There are two specific aims, objectives and hypotheses which will be tested:
Specific Aim 1: To develop and refine a YPAR-MH curriculum, guided by youth community,
research, and clinical experts. Four focus groups will be conducted with a maximum total of
24 youth to assess the youth responsiveness of the curriculum. A qualitative thematic
analysis of the focus group data will be conducted and the findings will be used to further
refine the curriculum.
Specific Aim 2: To finalize and evaluate the curriculum with a pre-post survey and focus
groups.
Objective 1: Conduct pilot testing of curriculum with 20 youth to further improve and
finalize curriculum.
Objective 2: Implement the finalized curriculum with 50 youth and examine the change in youth
outcomes pre to post curriculum based on evaluation survey and four focus groups.
Hypothesis 2a: Youth will experience a significant positive improvement from pre to post
curriculum for YPAR related outcomes: critical consciousness, research self-efficacy, and
ethnic/racial identity.
Hypothesis 2b: Youth will experience a modest positive improvement from pre to post
curriculum for mental health related outcomes: anxiety and depression, stress, and
resilience.