SuicideNCT04253002
Preventing Suicide in African American Adolescents
A study testing Robinson's Culturally Adapted Coping with Stress Course (A-CWS) in people with Suicide, run by DePaul University at 6 sites in United States.
Trial summary
The overarching aim of the Success Over Stress Prevention Project is to reduce African American youth suicide. This study examines the impact of a 15-session, group-delivered, culturally-grounded, cognitive-behavioral intervention (i.e., PI Robinson's Adapted-Coping with Stress Course [A-CWS]), on the outcomes of… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- Robinson's Culturally Adapted Coping with Stress Course (A-CWS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Feb 2022to 30 Jun 2026
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students: Enrolled 9th grade student at time of initial enrollment at participating high school
- Parents/guardians: Child enrolled in study
- Teachers: Student enrolled in study
Who cannot join
- Not a 9th grade student at time of initial enrollment
- No parent/legal guardian permission
- For parents and teachers: no students enrolled in study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Richard T. Crane High School
Chicago, Illinois, 60612
DePaul University
Chicago, Illinois, 60614
Dunbar Vocational Career Academy
Chicago, Illinois, 60616
Orr Academy High School
Chicago, Illinois, 60624
Wendell Phillips Academy High School
Chicago, Illinois, 60653
Proviso East High School
Maywood, Illinois, 60153
About this study
The overarching aim of the Success Over Stress Prevention Project is to reduce African American youth suicide. This study examines the impact of a 15-session, group-delivered, culturally-grounded, cognitive-behavioral intervention (i.e., PI Robinson's Adapted-Coping with Stress Course [A-CWS]), on the outcomes of interest, when it is delivered by social workers who are indigenous to the school system. The main objectives of this project are to (a) determine whether the intervention is effective when facilitated by social workers who are indigenous to the school system and (b) enhance resilience, increase adaptive coping strategies, and reduce both intrapersonal and interpersonal violence among youth receiving the prevention intervention. It is expected that increases in adaptive coping will lead to an increased ability for youth to manage stressors, thereby decreasing the incidence of suicide and violence among the youth. In addition, it is expected that evidence of the intervention's effectiveness, when facilitated by social workers who are indigenous to the school system, will lead to greater dissemination and sustainability of the intervention, thus, providing access to effective intervention resources to greater numbers of African American youth.
Read the detailed description
This study will establish the effectiveness of Robinson's Adapted-Coping with Stress Course (A-CWS) and test hypotheses pertaining to the mechanism of change by which the A-CWS reduces suicide risk. Additionally, this study is expected to augment current theoretical models of adolescent suicidality. This effectiveness trial will inform procedures for scaling up efficacious, high quality, and culturally-grounded suicide prevention programs for low-resourced, urban African American youth; as such, this study is practice relevant and expected to inform best practices for the prevention of suicide among African American adolescents. The specific aims are:
- To examine the effectiveness of the A-CWS intervention, as delivered by social workers who are indigenous to the school system, to reduce active suicidal ideation, within a sample of low-resourced, urban African American adolescents.
- To understand the mechanism by which the A-CWS intervention reduces suicide risk for low-resourced, urban African American adolescents.
- To establish the fidelity of an evidence-based, culturally-grounded coping with stress intervention (i.e., the A-CWS), developed for low-resourced, urban African American adolescents, delivered by social workers indigenous to the school system.
- To understand the extent that thwarted belongingness, perceived burdensomeness, and socio-ecological factors influence the development of active suicidal ideation.
- Conditions
- Suicide
- Being tested
- Robinson's Culturally Adapted Coping with Stress Course (A-CWS), Standard Care Control Condition
- Keywords
- Suicide, African American Adolescents, Prevention, Coping, Hope, Hopelessness
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robinson's Culturally Adapted Coping with Stress Course (A-CWS)Behavioural
Participants randomized to the experimental condition will take part in the Adapted Coping with Stress Course (A-CWS). The A-CWS is a 15-session, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills to adaptively cope with stress, using standard cognitive-behavioral strategies such as relaxation training and cognitive restructuring. Emphasis is given to the identification of individual and contextual factors associated with suicide risk and the unique day-to-day experiences of the youth, providing options for adaptive coping (e.g., positive thinking) that are culturally consistent. The A-CWS is structured and manualized to allow its transportability to service providers working in similar environments with similar youth.
Standard Care Control ConditionBehavioural
Students meeting criteria for study inclusion and randomized into the standard care condition will be referred to the school-based health center (SBHC) mental health provider for case management. Standard care may range from (1) brief intervention by the SBHC mental health provider to (2) outside referral to local community service providers; these determinations will be made by the SBHC mental health team.
| Study group | Role | What they receive |
|---|---|---|
| Robinson's Culturally Adapted Coping with Stress Course | Experimental | Not described Receives: Behavioral: Robinson's Culturally Adapted Coping with Stress Course (A-CWS) |
| Standard Care Control Condition | Active comparator | Not described Receives: Behavioral: Standard Care Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suicide Ideation
Suicide ideation will be measured using the Suicidal Ideation Questionnaire (SIQ-JR), a 15-item measure of adolescents' distress and suicidal intent. Scale scores range from 0 to 90, with higher scores meaning a worse outcome (i.e., greater suicide ideation).
Measured: Assessments will be administered through study completion, an average of every six months.
Secondary outcomes (3)
Change in Adaptive Coping
Adaptive Coping will be measured using The Adolescent Coping Orientation for Problem Behaviors (A-COPE), which is a 54 item self-report questionnaire that measures coping strategies among adolescents
Measured: Assessments will be administered through study completion, an average of every six months.
Change in Hope
Hope will be measured using the The Children's Hope Scale (CHS), a six-item self-report measure of children's perceived interpersonal competencies, including the belief that their goals can be met.
Measured: Assessments will be administered through study completion, an average of every six months.
Change in Hopelessness
Hopelessness will be measured using the Hopelessness Scale for Children (HSC). The HSC consists of 17 true-false items. The domains measured include: feelings about the future, loss of motivation, and future expectations
Measured: Assessments will be administered through study completion, an average of every six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePaul University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- LaVome Robinson, PhD, Principal investigator, DePaul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253002
- Sponsor's protocol ID
- LR060519PSY
- Other IDs
- 1R01MH1183182
- Status last verified
- Jun 2024
- First submitted
- 29 Jan 2020
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Suicide in African American Adolescents
- ClinicalTrials.gov ID
- NCT04253002
- Acronym / sponsor ID
- LR060519PSY
- Conditions
- Suicide
- Keywords
- Suicide, African American Adolescents, Prevention, Coping, Hope, Hopelessness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (actual)
- Lead sponsor
- DePaul UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Feb 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 overarching aim of the Success Over Stress Prevention Project is to reduce African American youth suicide. This study examines the impact of a 15-session, group-delivered, culturally-grounded, cognitive-behavioral intervention (i.e., PI Robinson's Adapted-Coping with Stress Course [A-CWS]), on the outcomes of interest, when it is delivered by social workers who are indigenous to the school system. The main objectives of this project are to (a) determine whether the intervention is effective when facilitated by social workers who are indigenous to the school system and (b) enhance resilience, increase adaptive coping strategies, and reduce both intrapersonal and interpersonal violence among youth receiving the prevention intervention. It is expected that increases in adaptive coping will lead to an increased ability for youth to manage stressors, thereby decreasing the incidence of suicide and violence among the youth. In addition, it is expected that evidence of the intervention's effectiveness, when facilitated by social workers who are indigenous to the school system, will lead to greater dissemination and sustainability of the intervention, thus, providing access to effective intervention resources to greater numbers of African American youth.
Detailed description
This study will establish the effectiveness of Robinson's Adapted-Coping with Stress Course (A-CWS) and test hypotheses pertaining to the mechanism of change by which the A-CWS reduces suicide risk. Additionally, this study is expected to augment current theoretical models of adolescent suicidality. This effectiveness trial will inform procedures for scaling up efficacious, high quality, and culturally-grounded suicide prevention programs for low-resourced, urban African American youth; as such, this study is practice relevant and expected to inform best practices for the prevention of suicide among African American adolescents. The specific aims are:
- To examine the effectiveness of the A-CWS intervention, as delivered by social workers who are indigenous to the school system, to reduce active suicidal ideation, within a sample of low-resourced, urban African American adolescents.
- To understand the mechanism by which the A-CWS intervention reduces suicide risk for low-resourced, urban African American adolescents.
- To establish the fidelity of an evidence-based, culturally-grounded coping with stress intervention (i.e., the A-CWS), developed for low-resourced, urban African American adolescents, delivered by social workers indigenous to the school system.
- To understand the extent that thwarted belongingness, perceived burdensomeness, and socio-ecological factors influence the development of active suicidal ideation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robinson's Culturally Adapted Coping with Stress Course | Experimental | Behavioral: Robinson's Culturally Adapted Coping with Stress Course (A-CWS) |
| Standard Care Control Condition | Active comparator | Behavioral: Standard Care Control Condition |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Students: Enrolled 9th grade student at time of initial enrollment at participating high school
- Parents/guardians: Child enrolled in study
- Teachers: Student enrolled in study
Key exclusion criteria (3 listed)
- Not a 9th grade student at time of initial enrollment
- No parent/legal guardian permission
- For parents and teachers: no students enrolled in study
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 |
|---|---|---|
| Robinson's Culturally Adapted Coping with Stress Course (A-CWS)Participants randomized to the experimental condition will take part in the Adapted Coping with Stress Course (A-CWS). The A-CWS is a 15-session, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills to adaptively cope with stress, using standard cognitive-behavioral strategies such as relaxation training and cognitive restructuring. Emphasis is given to the identification of individual and contextual factors associated with suicide risk and the unique day-to-day experiences of the youth, providing options for adaptive coping (e.g., positive thinking) that are culturally consistent. The A-CWS is structured and manualized to allow its transportability to service providers working in similar environments with similar youth. | Behavioural | Robinson's Culturally Adapted Coping with Stress Course |
| Standard Care Control ConditionStudents meeting criteria for study inclusion and randomized into the standard care condition will be referred to the school-based health center (SBHC) mental health provider for case management. Standard care may range from (1) brief intervention by the SBHC mental health provider to (2) outside referral to local community service providers; these determinations will be made by the SBHC mental health team. | Behavioural | Standard Care Control Condition |
Primary outcome
Change in Suicide Ideation
Time frame: Assessments will be administered through study completion, an average of every six months.
Suicide ideation will be measured using the Suicidal Ideation Questionnaire (SIQ-JR), a 15-item measure of adolescents' distress and suicidal intent. Scale scores range from 0 to 90, with higher scores meaning a worse outcome (i.e., greater suicide ideation).
3 secondary outcomes
Change in Adaptive Coping
Time frame: Assessments will be administered through study completion, an average of every six months.
Change in Hope
Time frame: Assessments will be administered through study completion, an average of every six months.
Change in Hopelessness
Time frame: Assessments will be administered through study completion, an average of every six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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.
LaVome Robinson, PhD principal investigator
DePaul University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robinson's Culturally Adapted Coping with Stress Course (A-CWS) in people with Suicide, run by DePaul University at 6 sites in United States.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Change in Suicide Ideation (time frame: Assessments will be administered through study completion, an average of every six months.). 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 5 Jun 2024.