Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03954457 |
Other study ID # |
LR052913PSY |
Secondary ID |
R01HD072293 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 5, 2013 |
Est. completion date |
July 31, 2020 |
Study information
Verified date |
August 2021 |
Source |
DePaul University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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]). 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.
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.