Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04234815
Status:
COMPLETED
Last Update Posted:
2022-09-29
First Post:
2020-01-16
Brief Title:
Evaluating Impacts of CSS for Veterans and Their Families in Ukraine
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Evaluating Impacts of a Brief Psychosocial Workshop for Veterans and Their Families in Ukraine
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This cluster-randomized controlled trial c-RCT evaluates the effectiveness of a brief single-session psychosocial workshop CETA Short Session CSS for reducing symptoms of distress and functional impairment and increasing treatment engagement among conflict veterans and their families in Ukraine The CSS workshop includes psychoeducation review of a self-assessment safety screening and training in cognitive coping This will be evaluated against a single-session comparison workshop that includes all of the same workshop elements except for cognitive coping Registration for both conditions includes completion of a self-assessment Participants with safety concerns or very severe symptoms will be immediately referred to mental health treatment others will be asked to wait for one month before being reassessed and if indicated referred to mental health treatment Both conditions include an individual check-in phone call one week after the workshop Distress and functional impairment outcomes will be assessed one month from baseline Treatment engagement outcomes will be assessed three months from referral The investigators hypothesize that individuals attending sessions randomized to CSS will show greater improvement in mental health outcomes and greater treatment engagement than those attending sessions randomized to the comparison condition
With the onset of the COVID-19 pandemic in Spring 2019 the RCT was paused to develop and pilot an online version of both the CSS and comparison workshop The trial protocol has now been expanded to continue the effectiveness trial while allowing for both online and whenif feasible in-person intervention delivery
With the onset of the COVID-19 pandemic in Spring 2019 the RCT was paused to develop and pilot an online version of both the CSS and comparison workshop The trial protocol has now been expanded to continue the effectiveness trial while allowing for both online and whenif feasible in-person intervention delivery
Detailed Description:
Community-based organizations in Ukraine that are currently providing social services to veterans or their families and are interested in receiving training to provide CSS will be engaged as implementing partners Individuals selected to be providers at these organizations will complete a 2-day Provider Training and will additionally receive ongoing supervision over the course of the study to ensure intervention fidelity and appropriate response and support to individuals needing referral to mental health treatment
Cluster-level randomization to CSS or eTAU will be carried out at the workshop level within provider such that all Providers will deliver both the CSS and eTAU workshops to groups that have been randomly allocated to either receive CSS or eTAU In this way all organizations will offer both CSS and eTAU integrated into each organizations regular program offerings and advertised through organizations regular communication channels
As part of the registration and triage procedures included as regular programming in both arms of the trial participants will self-complete a short locally validated Self-Assessment Form that assesses symptoms of distress depression post-traumatic stress functional impairment and safety risk two safety-related questions assessing recent thoughts of harm to self or others This assessment will be completed in advance and reviewed by an ME staff member prior to the workshop but assessment scores will not determine workshop eligibility eg people with low scores can still participate One exception to this is that any individuals who respond positively to either of the safety questions will be contacted by the CSSeTAU provider within 24-hours for further safety assessment If no safety issues are identified they will be registered for the workshop as normal however identified safety issues will trigger an appropriate safety planning or referral response as described below which may include bypassing the workshop in lieu of direct enrollment in treatment services At the end of the workshop participants will be informed of the study and invited to participate those who agree will provide informed consent
After the workshop as part of regular programming the provider will follow up individually with participants to discuss recommended next steps Evaluation of level of need and therefore choice of follow-up response will be made by the provider using the self-assessment results as well as any information reported to the provider during the workshop such as new safety concerns or changes in problem scores Follow-up contacts will be ordered by priority
1 Individuals who indicate any new safety concerns at the workshop will be contacted within 24 hours for further assessment to determine the appropriate referrals andor safety plan
2 Individuals with high symptom scores but no safety concerns will be contacted within 72 hours and offered a referral to outpatient mental health care
3 Individuals with moderate symptom scores will be contacted within 1 week for triage and encouraged to use the newly learned skills over the next month On that triage phone call participants will be told they will be re-assessed in one month to determine if they still require mental health treatment at which time they would be referred if indicated For those who attended CSS rather than eTAU providers will also ask about participant use of the cognitive coping skill over the past week including asking them how often theyve used it whether it has been helpful and soliciting an example through a series of questions that walk them through the skill
At one month all study participants who were not immediately referred to outpatient mental health services at baseline will be sent an individual link to re-administer the self-assessment the CSS skill check and complete an implementation feedback questionnaire
For all study participants who receive an outpatient mental health referral either immediate or delayed engagement outcomes will be assessed three months following referral
Cluster-level randomization to CSS or eTAU will be carried out at the workshop level within provider such that all Providers will deliver both the CSS and eTAU workshops to groups that have been randomly allocated to either receive CSS or eTAU In this way all organizations will offer both CSS and eTAU integrated into each organizations regular program offerings and advertised through organizations regular communication channels
As part of the registration and triage procedures included as regular programming in both arms of the trial participants will self-complete a short locally validated Self-Assessment Form that assesses symptoms of distress depression post-traumatic stress functional impairment and safety risk two safety-related questions assessing recent thoughts of harm to self or others This assessment will be completed in advance and reviewed by an ME staff member prior to the workshop but assessment scores will not determine workshop eligibility eg people with low scores can still participate One exception to this is that any individuals who respond positively to either of the safety questions will be contacted by the CSSeTAU provider within 24-hours for further safety assessment If no safety issues are identified they will be registered for the workshop as normal however identified safety issues will trigger an appropriate safety planning or referral response as described below which may include bypassing the workshop in lieu of direct enrollment in treatment services At the end of the workshop participants will be informed of the study and invited to participate those who agree will provide informed consent
After the workshop as part of regular programming the provider will follow up individually with participants to discuss recommended next steps Evaluation of level of need and therefore choice of follow-up response will be made by the provider using the self-assessment results as well as any information reported to the provider during the workshop such as new safety concerns or changes in problem scores Follow-up contacts will be ordered by priority
1 Individuals who indicate any new safety concerns at the workshop will be contacted within 24 hours for further assessment to determine the appropriate referrals andor safety plan
2 Individuals with high symptom scores but no safety concerns will be contacted within 72 hours and offered a referral to outpatient mental health care
3 Individuals with moderate symptom scores will be contacted within 1 week for triage and encouraged to use the newly learned skills over the next month On that triage phone call participants will be told they will be re-assessed in one month to determine if they still require mental health treatment at which time they would be referred if indicated For those who attended CSS rather than eTAU providers will also ask about participant use of the cognitive coping skill over the past week including asking them how often theyve used it whether it has been helpful and soliciting an example through a series of questions that walk them through the skill
At one month all study participants who were not immediately referred to outpatient mental health services at baseline will be sent an individual link to re-administer the self-assessment the CSS skill check and complete an implementation feedback questionnaire
For all study participants who receive an outpatient mental health referral either immediate or delayed engagement outcomes will be assessed three months following referral
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None