SuicideNCT03954457
Social Ecology and the Prevention of Suicide and Aggression in African American Youth
A study testing A-CWS in people with Suicide and Aggression, run by DePaul University at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of a culturally-grounded, school-based suicide and aggression preventive intervention for African American adolescents (Adapted-Coping with Stress Course [A-CWS]). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Aggression
- What is being tested?
- A-CWS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 939 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2013to 31 Jul 2020
- 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
- Enrolled ninth-grade student, their parent/guardian, or primary teacher at participating school
Who cannot join
- Imminent suicide risk
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the efficacy of a culturally-grounded, school-based suicide and aggression preventive intervention for African American adolescents (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 for coping with stress. Emphasis is given to the identification of stress unique to the day-to-day experiences of the youths and options for reducing stress that are culturally consistent. A total of four public high schools in a large Midwestern metropolitan area participated in this study that used a randomized-controlled design, with randomization occurring at the individual level. Participants were randomized either to the A-CWS intervention condition, or to a standard care control condition. This study had three hypotheses: (1) The intervention would raise adaptive coping, relative to the standard care control condition; (2) coping skills would explain the effects of the A-CWS intervention on problematic outcomes (i.e., suicidality, aggression); and (3) socio-ecological factors (i.e., neighborhood and family characteristics) would influence the effect of the A-CWS intervention on coping skills, and the effect of coping skills on problematic outcomes.
Read the detailed description
Participants were recruited from four urban, public schools, serving predominantly low-income, African American adolescents. Recruitment occurred over two years, with two cohorts of ninth-grade students recruited. Participants who returned student assent and active parent/guardian permission were screened for imminent suicide risk. Those participants who were identified as at imminent risk for suicide were referred to mental health professionals at the school-based health center for risk assessment and appropriate services. Participants not at imminent risk completed a baseline assessment of coping, aggression, and suicidality, and were randomly assigned to either the A-CWS intervention or standard care control conditions. Randomization occurred at the individual level.
Participants assigned to the A-CWS intervention condition received the 15-week A-CWS intervention. The intervention was facilitated by master's-level practitioners and implemented at the participating school during a non-instructional period of the school day. Intervention groups consisted of 8 to 10 participants, and intervention sessions were held for 45 minutes, once per week. Participants assigned to the standard care control condition were assigned to work with the school-based health center (SBHC) to receive standard behavioral services as delivered by SBHC mental health professionals.
To assess outcomes of adaptive coping, suicidality, and interpersonal aggression, participants were assessed at multiple timepoints. After completing a brief screening assessment, all participants, regardless of condition, were assessed a total of four times: (1) at baseline, prior to randomization, (2) immediately following the conclusion of the A-CWS intervention, (3) 6 months after the conclusion of the intervention, and (4) 12 months after the conclusion of the intervention.
- Conditions
- Suicide, Aggression
- Being tested
- A-CWS, Standard Care Control
- Keywords
- Suicide, Aggression, Prevention, Culturally-Adapted, African American Adolescents
- Medical subject headings
- Suicide, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-CWSBehavioural
The A-CWS intervention is a 15-session culturally-grounded, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills for coping with stress. The intervention structure allows implementation within traditional school and other community settings. The A-CWS uses standard cognitive-behavioral strategies (e.g., relaxation training, cognitive restructuring) to help African American youth identify and cope with individual and contextual stressors, using culturally consistent coping strategies. The intervention emphasizes the identification and management of stressors associated with suicide risk (e.g., racism-related stress, community violence exposure) and the unique experiences of low-resourced, urban African American adolescents (e.g., community violence exposure). The structured, manualized A-CWS curriculum is designed to be sustainable and user-friendly, to ensure that the A-CWS is delivered effectively and with a high degree of fidelity.
Standard Care ControlBehavioural
The standard care control condition consisted of standard case management services delivered by the SBHC. Participants randomly assigned to the standard care control condition were referred to the SBHC social worker for case management. Standard care ranged from brief intervention by the SBHC social worker, to more intensive intervention by the SBHC social worker, to outside referral to local community service providers. SBHC social workers determined type and duration of services based on individual participant needs.
| Study group | Role | What they receive |
|---|---|---|
| A-CWS Intervention | Experimental | Participants received A-CWS Intervention. Receives: Behavioral: A-CWS |
| Standard Care Control | Active comparator | Participants received standard care. Receives: Behavioral: Standard Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suicide Ideation
Suicide ideation was measured with the Center for Epidemiological Studies - Depression (CES-D) Appended Suicide Measure, a 4-item self-report inventory that assesses suicide ideation during the last week.
Measured: Baseline, post-test, 6-month follow-up, 12-month follow-up
Change in Aggression
Aggression was measured with a reduced 12-item version of the Aggression-Problem Behavior Frequency Scale, a self-report inventory that assesses the frequency of aggression in the last 30 days. This instrument has two subscales: physical aggression and non-physical aggression. Aggression was also measured using the Buss-Perry Aggression Questionnaire Short Form, a 12-item self-report inventory of aggression with four subscales: physical aggression, verbal aggression, anger, and hostility. In addition, aggression was measured with student behavioral data from participating schools, including number of detentions, suspensions, and reasons for detentions/suspensions. This data was used to identify the number of aggressive episodes per student and provided a secondary, archival measure of aggression.
Measured: Baseline, post-test, 6-month follow-up, 12-month follow-up
Change in Coping
Coping was measured with a reduced 36-item version of the Adolescent Coping Orientation for Problem Experiences Measure, a self-report inventory that assesses frequency of use for coping methods used in response to stress. Seven subscales were included to assess preferred coping styles targeted by the intervention: ventilating feelings, seeking diversions, developing self-reliance, developing social support, investing in close friends, engaging in demanding activity, and relaxing.
Measured: Baseline, post-test, 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start5 Feb 2013
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 939 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePaul University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, LaVome Robinson, DePaul University
- Investigators
- LaVome Robinson, Ph.D., Principal investigator, DePaul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954457
- Sponsor's protocol ID
- LR052913PSY
- Other IDs
- R01HD072293
- Status last verified
- Aug 2021
- First submitted
- 15 May 2019
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robinson WL, Whipple CR, Keenan K, Flack CE, Lemke S, Jason LA. Reducing suicidal ideation in African American adolescents: A randomized controlled clinical trial. J Consult Clin Psychol. 2024 Feb;92(2):61-74. doi: 10.1037/ccp0000849. Epub 2023 Sep 28.
PubMed 37768628
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Ecology and the Prevention of Suicide and Aggression in African American Youth
- ClinicalTrials.gov ID
- NCT03954457
- Acronym / sponsor ID
- LR052913PSY
- Conditions
- Suicide, Aggression
- Keywords
- Suicide, Aggression, Prevention, Culturally-Adapted, African American Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 939 participants (actual)
- Lead sponsor
- DePaul UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Feb 2013 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 17 May 2019 (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 purpose of this study is to examine the efficacy of a culturally-grounded, school-based suicide and aggression preventive intervention for African American adolescents (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 for coping with stress. Emphasis is given to the identification of stress unique to the day-to-day experiences of the youths and options for reducing stress that are culturally consistent. A total of four public high schools in a large Midwestern metropolitan area participated in this study that used a randomized-controlled design, with randomization occurring at the individual level. Participants were randomized either to the A-CWS intervention condition, or to a standard care control condition. This study had three hypotheses: (1) The intervention would raise adaptive coping, relative to the standard care control condition; (2) coping skills would explain the effects of the A-CWS intervention on problematic outcomes (i.e., suicidality, aggression); and (3) socio-ecological factors (i.e., neighborhood and family characteristics) would influence the effect of the A-CWS intervention on coping skills, and the effect of coping skills on problematic outcomes.
Detailed description
Participants were recruited from four urban, public schools, serving predominantly low-income, African American adolescents. Recruitment occurred over two years, with two cohorts of ninth-grade students recruited. Participants who returned student assent and active parent/guardian permission were screened for imminent suicide risk. Those participants who were identified as at imminent risk for suicide were referred to mental health professionals at the school-based health center for risk assessment and appropriate services. Participants not at imminent risk completed a baseline assessment of coping, aggression, and suicidality, and were randomly assigned to either the A-CWS intervention or standard care control conditions. Randomization occurred at the individual level.
Participants assigned to the A-CWS intervention condition received the 15-week A-CWS intervention. The intervention was facilitated by master's-level practitioners and implemented at the participating school during a non-instructional period of the school day. Intervention groups consisted of 8 to 10 participants, and intervention sessions were held for 45 minutes, once per week. Participants assigned to the standard care control condition were assigned to work with the school-based health center (SBHC) to receive standard behavioral services as delivered by SBHC mental health professionals.
To assess outcomes of adaptive coping, suicidality, and interpersonal aggression, participants were assessed at multiple timepoints. After completing a brief screening assessment, all participants, regardless of condition, were assessed a total of four times: (1) at baseline, prior to randomization, (2) immediately following the conclusion of the A-CWS intervention, (3) 6 months after the conclusion of the intervention, and (4) 12 months after the conclusion of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-CWS Intervention | Experimental | Behavioral: A-CWSParticipants received A-CWS Intervention. |
| Standard Care Control | Active comparator | Behavioral: Standard Care ControlParticipants received standard care. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled ninth-grade student, their parent/guardian, or primary teacher at participating school
Key exclusion criteria (1 listed)
- Imminent suicide risk
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 |
|---|---|---|
| A-CWSThe A-CWS intervention is a 15-session culturally-grounded, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills for coping with stress. The intervention structure allows implementation within traditional school and other community settings. The A-CWS uses standard cognitive-behavioral strategies (e.g., relaxation training, cognitive restructuring) to help African American youth identify and cope with individual and contextual stressors, using culturally consistent coping strategies. The intervention emphasizes the identification and management of stressors associated with suicide risk (e.g., racism-related stress, community violence exposure) and the unique experiences of low-resourced, urban African American adolescents (e.g., community violence exposure). The structured, manualized A-CWS curriculum is designed to be sustainable and user-friendly, to ensure that the A-CWS is delivered effectively and with a high degree of fidelity. | Behavioural | A-CWS Intervention |
| Standard Care ControlThe standard care control condition consisted of standard case management services delivered by the SBHC. Participants randomly assigned to the standard care control condition were referred to the SBHC social worker for case management. Standard care ranged from brief intervention by the SBHC social worker, to more intensive intervention by the SBHC social worker, to outside referral to local community service providers. SBHC social workers determined type and duration of services based on individual participant needs. | Behavioural | Standard Care Control |
Primary outcome
Change in Suicide Ideation
Time frame: Baseline, post-test, 6-month follow-up, 12-month follow-up
Suicide ideation was measured with the Center for Epidemiological Studies - Depression (CES-D) Appended Suicide Measure, a 4-item self-report inventory that assesses suicide ideation during the last week.
Change in Aggression
Time frame: Baseline, post-test, 6-month follow-up, 12-month follow-up
Aggression was measured with a reduced 12-item version of the Aggression-Problem Behavior Frequency Scale, a self-report inventory that assesses the frequency of aggression in the last 30 days. This instrument has two subscales: physical aggression and non-physical aggression. Aggression was also measured using the Buss-Perry Aggression Questionnaire Short Form, a 12-item self-report inventory of aggression with four subscales: physical aggression, verbal aggression, anger, and hostility. In addition, aggression was measured with student behavioral data from participating schools, including number of detentions, suspensions, and reasons for detentions/suspensions. This data was used to identify the number of aggressive episodes per student and provided a secondary, archival measure of aggression.
Change in Coping
Time frame: Baseline, post-test, 6-month follow-up, 12-month follow-up
Coping was measured with a reduced 36-item version of the Adolescent Coping Orientation for Problem Experiences Measure, a self-report inventory that assesses frequency of use for coping methods used in response to stress. Seven subscales were included to assess preferred coping styles targeted by the intervention: ventilating feelings, seeking diversions, developing self-reliance, developing social support, investing in close friends, engaging in demanding activity, and relaxing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Derived from this study: PubMed 37768628Robinson WL, Whipple CR, Keenan K, Flack CE, Lemke S, Jason LA. Reducing suicidal ideation in African American adolescents: A randomized controlled clinical trial. J Consult Clin Psychol. 2024 Feb;92(2):61-74. doi: 10.1037/ccp0000849. Epub 2023 Sep 28.
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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, Ph.D. principal investigator
DePaul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-CWS in people with Suicide and Aggression, run by DePaul University at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Baseline, post-test, 6-month follow-up, 12-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03954457, which also lists 1 linked publication.
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 17 Aug 2021.