Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515236
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
Strategic Treatment and Assessment for Youth STAY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Strategic Treatment Assessment With Youth STAY A Measurement-based Care Approach to Promote Treatment Retention Among Racial and Ethnic Minoritized Youth With Depression or Suicide Risk
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAY
Brief Summary:
This multi-method multi-phase pilot trial is designed to explore initial implementation and effectiveness of a theoretically-driven culturally-tailored measurement-based care MBC approach Strategic Treatment Assessment for Youth STAY for racial and ethnic minoritized REM youth with depressive symptoms or suicidal thoughts and behaviors STB STAY offers an innovative culturally-tailored approach to retain REM youth with depressive symptoms with or without STB in mental health treatment In this R34 study the investigators will first refine the STAY clinical protocol and implementation plan develop STAY instrumentation STAY Aim 1 and then pilot test the effectiveness of STAY in three community-based mental health clinics Aim 2 Aim 2 focuses on testing the protocol through a pilot Hybrid Type 2 trial by comparing clinicians randomly assigned to STAY intervention condition as compared to those assigned to the MBC As Usual active comparison condition Results from this pilot trial will inform optimal study procedures measures and site selection for a subsequent fully-powered Hybrid Type 2 trial to examine STAY implementation effectiveness and scalability
Detailed Description:
This multi-method multi-phase pilot trial is designed to explore initial implementation and effectiveness of a theoretically-driven culturally-tailored measurement-based care MBC approach Strategic Treatment Assessment for Youth STAY for racial and ethnic minoritized REM youth with depressive symptoms or suicidal thoughts and behaviors STB STAY offers an innovative culturally-tailored approach to retain REM youth with depressive symptoms with or without STB in mental health treatment In this R34 study the investigators will first refine the STAY clinical protocol and implementation plan develop STAY instrumentation STAY Aim 1 and then pilot test the effectiveness of STAY in three community-based mental health clinics Aim 2 Aim 2 focuses on testing the protocol through a pilot Hybrid Type 2 trial by comparing clinicians randomly assigned to STAY intervention condition as compared to those assigned to the MBC As Usual active comparison condition Results from this pilot trial will inform optimal study procedures measures and site selection for a subsequent fully-powered Hybrid Type 2 trial to examine STAY implementation effectiveness and scalability
In Aim 1 of the research plan the investigators will refine the STAY protocol and intervention plan based on the study teams preliminary development of the STAY model protocol and implementation plan The STAY protocol includes a clinician manual including clinician guide for each STAY component step-by-step instructions sample scripts clinical vignettes and assessment measures The STAY implementation plan includes the STAY training goals and objectives responsibilities and timelines The investigators will employ user-centered design UCD methods guided by a Discover Design Build and Test DDBT Development process to revise the STAY protocol and implementation plan to ensure STAY is aligned with the needs of deployment contexts and end users A sample size of N12 users ie clinicians and clinical administrators divided into three cohorts of four participants each will be used as per recommendations for user-centered design UCD testing for complex interventions Aligned with best practices sampling will balance both novice and more experienced users Participants will interact with the STAY protocol and implementation plan prototypes and engage in usability tests including cognitive walk-throughs and lab-based user testing Participants will also compete the 10-item Intervention Usability Scale Iterative data analysis and prototyping between each cohort will be used to rapidly refine the STAY protocol and implementation plan to optimize usability Then the STAY Observational Coding System SOCS will be developed to assess its feasibility and scalability for future trials as well as a 10-item STAY Knowledge Skills and Attitudes KSAT Measure to tap core knowledge domains and implementation mechanisms to be assessed in the Aim 2 trial At the end of Aim 1 the study team will have refined a STAY protocol and implementation plan The investigators will also have an observational coding system to assess STAY fidelity and a brief pragmatic measure to assess knowledge attitudes and practices of clinicians trained in STAY
In Aim 2 of the research plan the investigators will conduct a pilot effectiveness-implementation Hybrid Type 2 trial of STAY vs MBC As Usual Using a randomized design 20 clinicians at three public mental health sites will be stratified by site and randomly assigned to STAY intervention condition or to MBC As Usual active control condition Clinicians randomized to STAY will receive the STAY protocol and MBC As Usual clinicians will receive standard MBC educational materials used in the study teams other MBC studies Clinicians in both conditions will attend a one-day training and monthly 1-hour post-training consultation calls for 6 months Clinicians in both conditions will be asked to implement MBC with REM youth and their families who meet eligibility criteria and facilitate study referrals All clinicians will complete measures at baseline pre-training and post-training and post-implementation 6-month post-training follow-up Half of the clinicians in each condition will be randomly selected to participate in the SOCS Youthcaregiver dyads will be recruited on a rolling basis due to enrollment patterns at the clinical sites which is why the investigators are planning 20 months of data collection to achieve 4-month follow-up measures from all youth Youth and caregivers will complete measures at baseline within 30 days of their first contact with the site 2-months 8 weeks and 4-months 16 weeks following the baseline measure Youth measures capture implementation outcomes eg clinicians cultural humility and cultural comfort engagement mechanisms eg treatment relevance and acceptability therapeutic alliance service outcomes eg attitudinal engagement and youth symptom outcomes eg depression symptoms suicidal ideation and behavior Caregiver measures capture implementation outcomes eg clinicians cultural comfort engagement mechanisms eg treatment relevance and acceptability therapeutic alliance and service outcomes eg attitudinal engagement Youth and caregivers will also be asked to consent to secondary data collection by the study team to obtain medical records information for their attendance discharge reason and fidelity of MBC Clinician measures capture implementation outcomes eg feasibility acceptability appropriateness
The investigators will assess STAY implementation outcomes of fidelity feasibility acceptability and appropriateness primary outcomes Further the investigators will explore whether STAY as compared to MBC As Usual will result in secondary outcomes 1 Greater therapeutic alliance and treatment relevance and acceptability engagement mechanisms 2 Greater session attendance attitudinal engagement and treatment completion service outcomes and 3 Greater reduction in youth depressive symptoms suicidal ideation and behavior treatment outcomes
Appropriateness of Methods Follow up intervals are informed by typical treatment length and retention measures in prior research Sample size was determined based on the resources and time frame constraints of 3 years participating clinicians and families will be recruited in year 1 quarter 4 to finish all data collection in year 2 Also individual clinician patterns in MBC administration and feedback can feasibly be examined with this small sample size as has been useful in other implementation pilot studies
Knowledge gained from this pilot will be used to refine the research strategy for a fully powered subsequent R01 with optimal procedures Piloting STAY with procedures that would be exactly mirrored in a future multi-site R01 provides numerous learning opportunities about the feasibility and parameters of measures study recruitment and data collection procedures eg collecting youth- and caregiver-reported data over the phone clinician engagement in consultation calls record review procedures to track fidelity missing data patterns and range and pattern of session attendance for both the STAY and MBC As Usual groups Also site variation in this trial is expected to provide information about how different sites handle STAY implementation which the investigators can further investigate as site-level variation in a fully-powered R01 trial Outcomes of this trial could inform potential additions to the R01 design such as 1 enhancements to STAY to more comprehensively address logistical barriers 2 testing STAY among REM adolescents with conditions other than depression andor 3 a fully-powered Type 2 Hybrid trial to detect clinician effects moderators and effectiveness outcomes
In Aim 1 of the research plan the investigators will refine the STAY protocol and intervention plan based on the study teams preliminary development of the STAY model protocol and implementation plan The STAY protocol includes a clinician manual including clinician guide for each STAY component step-by-step instructions sample scripts clinical vignettes and assessment measures The STAY implementation plan includes the STAY training goals and objectives responsibilities and timelines The investigators will employ user-centered design UCD methods guided by a Discover Design Build and Test DDBT Development process to revise the STAY protocol and implementation plan to ensure STAY is aligned with the needs of deployment contexts and end users A sample size of N12 users ie clinicians and clinical administrators divided into three cohorts of four participants each will be used as per recommendations for user-centered design UCD testing for complex interventions Aligned with best practices sampling will balance both novice and more experienced users Participants will interact with the STAY protocol and implementation plan prototypes and engage in usability tests including cognitive walk-throughs and lab-based user testing Participants will also compete the 10-item Intervention Usability Scale Iterative data analysis and prototyping between each cohort will be used to rapidly refine the STAY protocol and implementation plan to optimize usability Then the STAY Observational Coding System SOCS will be developed to assess its feasibility and scalability for future trials as well as a 10-item STAY Knowledge Skills and Attitudes KSAT Measure to tap core knowledge domains and implementation mechanisms to be assessed in the Aim 2 trial At the end of Aim 1 the study team will have refined a STAY protocol and implementation plan The investigators will also have an observational coding system to assess STAY fidelity and a brief pragmatic measure to assess knowledge attitudes and practices of clinicians trained in STAY
In Aim 2 of the research plan the investigators will conduct a pilot effectiveness-implementation Hybrid Type 2 trial of STAY vs MBC As Usual Using a randomized design 20 clinicians at three public mental health sites will be stratified by site and randomly assigned to STAY intervention condition or to MBC As Usual active control condition Clinicians randomized to STAY will receive the STAY protocol and MBC As Usual clinicians will receive standard MBC educational materials used in the study teams other MBC studies Clinicians in both conditions will attend a one-day training and monthly 1-hour post-training consultation calls for 6 months Clinicians in both conditions will be asked to implement MBC with REM youth and their families who meet eligibility criteria and facilitate study referrals All clinicians will complete measures at baseline pre-training and post-training and post-implementation 6-month post-training follow-up Half of the clinicians in each condition will be randomly selected to participate in the SOCS Youthcaregiver dyads will be recruited on a rolling basis due to enrollment patterns at the clinical sites which is why the investigators are planning 20 months of data collection to achieve 4-month follow-up measures from all youth Youth and caregivers will complete measures at baseline within 30 days of their first contact with the site 2-months 8 weeks and 4-months 16 weeks following the baseline measure Youth measures capture implementation outcomes eg clinicians cultural humility and cultural comfort engagement mechanisms eg treatment relevance and acceptability therapeutic alliance service outcomes eg attitudinal engagement and youth symptom outcomes eg depression symptoms suicidal ideation and behavior Caregiver measures capture implementation outcomes eg clinicians cultural comfort engagement mechanisms eg treatment relevance and acceptability therapeutic alliance and service outcomes eg attitudinal engagement Youth and caregivers will also be asked to consent to secondary data collection by the study team to obtain medical records information for their attendance discharge reason and fidelity of MBC Clinician measures capture implementation outcomes eg feasibility acceptability appropriateness
The investigators will assess STAY implementation outcomes of fidelity feasibility acceptability and appropriateness primary outcomes Further the investigators will explore whether STAY as compared to MBC As Usual will result in secondary outcomes 1 Greater therapeutic alliance and treatment relevance and acceptability engagement mechanisms 2 Greater session attendance attitudinal engagement and treatment completion service outcomes and 3 Greater reduction in youth depressive symptoms suicidal ideation and behavior treatment outcomes
Appropriateness of Methods Follow up intervals are informed by typical treatment length and retention measures in prior research Sample size was determined based on the resources and time frame constraints of 3 years participating clinicians and families will be recruited in year 1 quarter 4 to finish all data collection in year 2 Also individual clinician patterns in MBC administration and feedback can feasibly be examined with this small sample size as has been useful in other implementation pilot studies
Knowledge gained from this pilot will be used to refine the research strategy for a fully powered subsequent R01 with optimal procedures Piloting STAY with procedures that would be exactly mirrored in a future multi-site R01 provides numerous learning opportunities about the feasibility and parameters of measures study recruitment and data collection procedures eg collecting youth- and caregiver-reported data over the phone clinician engagement in consultation calls record review procedures to track fidelity missing data patterns and range and pattern of session attendance for both the STAY and MBC As Usual groups Also site variation in this trial is expected to provide information about how different sites handle STAY implementation which the investigators can further investigate as site-level variation in a fully-powered R01 trial Outcomes of this trial could inform potential additions to the R01 design such as 1 enhancements to STAY to more comprehensively address logistical barriers 2 testing STAY among REM adolescents with conditions other than depression andor 3 a fully-powered Type 2 Hybrid trial to detect clinician effects moderators and effectiveness outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None