Youth Participatory Action ResearchNCT04554420
Promoting Youth Mental Health in Inequitable Contexts: Applying Participatory Action Research
A study testing Youth Participatory Action Research-Mental Health Curriculum in people with Youth Participatory Action Research and Youth Mental Health, run by Charles Drew University of Medicine and Science.
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… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Youth Participatory Action Research, Youth Mental Health, Health Equity
- What is being tested?
- Youth Participatory Action Research-Mental Health Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- High school age youth, 14-17 years old
- Youth living in South Los Angeles
Who cannot join
- Not meeting the age range of 14-17 years old
- Youth not living in South Los Angeles
About this study
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.
Read the detailed 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.
- Being tested
- Youth Participatory Action Research-Mental Health Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Participatory Action Research-Mental Health CurriculumBehavioural
The mental health curriculum will focus on enhancing the knowledge, critical consciousness (i.e., exploration of systemic/racial problems), research self-efficacy, and other skills of youth to integrate their lived experiences and identity to learning about the intersection of system and community level issues in mental health. Activities will center on participatory action approaches to engaging youth in culturally/community responsive ways.
| Study group | Role | What they receive |
|---|---|---|
| Youth Participatory Action Research-Mental Health Curriculum | Experimental | Youth will be engaged with youth participatory approaches in learning about the intersection of mental health and systemic/community level issues. Receives: Behavioral: Youth Participatory Action Research-Mental Health Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical Consciousness Scale - Assessing change from pre-intervention to immediately post-intervention
Measure assesses capacity to critically analyze socio-political conditions, endorsement of social equity, and action to change perceived inequities; Subscale/Sample Item/Number of Items: a) Critical reflection perceived inequality: "Poor children have fewer chances to get a good high school education" (n=8), b) Critical reflection egalitarianism: "Group equality should be our ideal" (n=5), c) Critical action socio-political participation: "Participate in a discussion about a social or political issue (n=9); 6 point Likert- type (Strongly disagree to Strongly agree)
Measured: Measure will be implemented pre-intervention and immediately post-intervention
Research Self-Efficacy - Assessing change from pre-intervention to immediately post-intervention
Measure assesses perceived self-efficacy to conduct and analyze research; Sample item/Number of items: "I believe I can master research related knowledge" (n=4); 5 point Likert-type (Strongly disagree to Strongly Agree)
Measured: Measure will be implemented pre-intervention and immediately post-intervention
Multigroup Ethnic Identity Measure - Assessing change from pre-intervention to immediately post-intervention
Measure assesses multiple dimensions of ethnic/racial identity, including the following; Subscale/Sample items/Number of items: a) Ethnic behaviors: "I participate in cultural practices of my own group" (n=4), b) Affirmation and belonging: "I have a lot of pride in my ethnic group" (n=6), c) Ethnic identity achievement: "In order to learn more about my group, I have often talked to other people about my group" (n=4); 4 point Likert-type (Strongly disagree to Strongly agree)
Measured: Measure will be implemented pre-intervention and immediately post-intervention
Revised Child Anxiety and Depression Scale-Short Version - Assessing change from pre-intervention to immediately post-intervention
Measure assesses anxiety and depression in the general population/non-clinical of youth; Subscale/Sample items/Number of items: a) Anxiety: "Worries about things" (n=15), b) Depression: "Feels worthless" (n=10); 4 Likert-type (Never to Always)
Measured: Measure will be implemented pre-intervention and immediately post-intervention
Adolescent Distress-Eustress Scale - Assessing change from pre-intervention to immediately post-intervention
Measure assesses distress (negative stress) and eustress (positive stress) in adolescents; Subscale/Sample items/Number of items: a) Distress: "I felt overwhelmed" (n=5), b) Eustress: "I felt motivated" (n=5); 5 point Likert-type (Not like me to Very much like me)
Measured: Measure will be implemented pre-intervention and immediately post-intervention
Child and Youth Resilience Measure-28 - Assessing change from pre-intervention to immediately post-intervention
Measure assesses resilience in youth; Subscale/Sample items/Number of items: a) Individual: "I cooperate with people around me" (n=11), b) Caregiving: "My caregivers watch me closely" (n=7), c) Contextual: "I am treated fairly in my community" (n=10); 5 point Likert-type (Does not describe me at all to Describes me a lot)
Measured: Measure will be implemented pre-intervention and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study startFeb 2024 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Given recruitment challenges for youth focus groups, we are currently finalizing the creation of the intervention based on the focus groups. We plan to submit for new grant funding to implement a different intervention at a future date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Youth Participatory Action ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants (youth) will receive intervention (mental health curriculum) and a pre-intervention and post-intervention survey will be used to evaluate the intervention. Additionally, a set of focus groups will be conducted post-intervention to assess the feasibility, implementation process, and youth responsiveness. No control condition will be used for this pilot intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles County Department of Public Health
- Responsible party
- Sponsor
- Investigators
- Noe R Chavez, PhD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554420
- Sponsor's protocol ID
- U54MD007598
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Youth Mental Health in Inequitable Contexts: Applying Participatory Action Research
- ClinicalTrials.gov ID
- NCT04554420
- Acronym / sponsor ID
- U54MD007598
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Given recruitment challenges for youth focus groups, we are currently finalizing the creation of the intervention based on the focus groups. We plan to submit for new grant funding to implement a different intervention at a future date.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Los Angeles County Department of Public Health
- Study start
- Feb 2024 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants (youth) will receive intervention (mental health curriculum) and a pre-intervention and post-intervention survey will be used to evaluate the intervention. Additionally, a set of focus groups will be conducted post-intervention to assess the feasibility, implementation process, and youth responsiveness. No control condition will be used for this pilot intervention.
| Arm | Type | Receives |
|---|---|---|
| Youth Participatory Action Research-Mental Health Curriculum | Experimental | Behavioral: Youth Participatory Action Research-Mental Health CurriculumYouth will be engaged with youth participatory approaches in learning about the intersection of mental health and systemic/community level issues. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- High school age youth, 14-17 years old
- Youth living in South Los Angeles
Key exclusion criteria (2 listed)
- Not meeting the age range of 14-17 years old
- Youth not living in South Los Angeles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youth Participatory Action Research-Mental Health CurriculumThe mental health curriculum will focus on enhancing the knowledge, critical consciousness (i.e., exploration of systemic/racial problems), research self-efficacy, and other skills of youth to integrate their lived experiences and identity to learning about the intersection of system and community level issues in mental health. Activities will center on participatory action approaches to engaging youth in culturally/community responsive ways. | Behavioural | Youth Participatory Action Research-Mental Health Curriculum |
Primary outcome
Critical Consciousness Scale - Assessing change from pre-intervention to immediately post-intervention
Time frame: Measure will be implemented pre-intervention and immediately post-intervention
Measure assesses capacity to critically analyze socio-political conditions, endorsement of social equity, and action to change perceived inequities; Subscale/Sample Item/Number of Items: a) Critical reflection perceived inequality: "Poor children have fewer chances to get a good high school education" (n=8), b) Critical reflection egalitarianism: "Group equality should be our ideal" (n=5), c) Critical action socio-political participation: "Participate in a discussion about a social or political issue (n=9); 6 point Likert- type (Strongly disagree to Strongly agree)
Research Self-Efficacy - Assessing change from pre-intervention to immediately post-intervention
Time frame: Measure will be implemented pre-intervention and immediately post-intervention
Measure assesses perceived self-efficacy to conduct and analyze research; Sample item/Number of items: "I believe I can master research related knowledge" (n=4); 5 point Likert-type (Strongly disagree to Strongly Agree)
Multigroup Ethnic Identity Measure - Assessing change from pre-intervention to immediately post-intervention
Time frame: Measure will be implemented pre-intervention and immediately post-intervention
Measure assesses multiple dimensions of ethnic/racial identity, including the following; Subscale/Sample items/Number of items: a) Ethnic behaviors: "I participate in cultural practices of my own group" (n=4), b) Affirmation and belonging: "I have a lot of pride in my ethnic group" (n=6), c) Ethnic identity achievement: "In order to learn more about my group, I have often talked to other people about my group" (n=4); 4 point Likert-type (Strongly disagree to Strongly agree)
Revised Child Anxiety and Depression Scale-Short Version - Assessing change from pre-intervention to immediately post-intervention
Time frame: Measure will be implemented pre-intervention and immediately post-intervention
Measure assesses anxiety and depression in the general population/non-clinical of youth; Subscale/Sample items/Number of items: a) Anxiety: "Worries about things" (n=15), b) Depression: "Feels worthless" (n=10); 4 Likert-type (Never to Always)
Adolescent Distress-Eustress Scale - Assessing change from pre-intervention to immediately post-intervention
Time frame: Measure will be implemented pre-intervention and immediately post-intervention
Measure assesses distress (negative stress) and eustress (positive stress) in adolescents; Subscale/Sample items/Number of items: a) Distress: "I felt overwhelmed" (n=5), b) Eustress: "I felt motivated" (n=5); 5 point Likert-type (Not like me to Very much like me)
Child and Youth Resilience Measure-28 - Assessing change from pre-intervention to immediately post-intervention
Time frame: Measure will be implemented pre-intervention and immediately post-intervention
Measure assesses resilience in youth; Subscale/Sample items/Number of items: a) Individual: "I cooperate with people around me" (n=11), b) Caregiving: "My caregivers watch me closely" (n=7), c) Contextual: "I am treated fairly in my community" (n=10); 5 point Likert-type (Does not describe me at all to Describes me a lot)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noe R Chavez, PhD principal investigator
Charles Drew University of Medicine and Science
Questions about this trial
What is this clinical trial studying?
A study testing Youth Participatory Action Research-Mental Health Curriculum in people with Youth Participatory Action Research and Youth Mental Health, run by Charles Drew University of Medicine and Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical Consciousness Scale - Assessing change from pre-intervention to immediately post-intervention (time frame: Measure will be implemented pre-intervention and immediately post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.