Clinical trial NCT06194331: Optimizing Suicide Prevention Strategies for Pediatric Primary Care
Official title: Optimizing Suicide Prevention Strategies for Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicidal and Self-injurious Behavior
Depression
Keywords: Suicidal Ideation
Suicidal and Self-injurious Behavior
Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pediatric Research in Office Settings
name: National Institute of Mental Health (NIMH)
First posted: 2024-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study will utilize a stepped wedge design in which 4 PROS practices start with usual care initially and are randomly chosen to transition to iCHART-cASAP at different times in such a way as half of the participants will receive TAU and half will receive iCHART-cASAP. All sites will be initially monitored for at least 3 months during TAU. This will be followed by a staggered adoption of iCHART-cASAP. At each time period, a new site will begin implementing the intervention. Block randomization determines the order each site begins the intervention phase. Each time period (approximately 3 months), a web-based system will be used to assign the next clinic to begin using iCHART-cASAP. Research staff will be available to assist with consenting participants and assisting with study procedures.
Primary purpose: PREVENTION

Brief summary: Increasing rates of suicidal thoughts and behaviors among adolescents must be addressed. The study will adapt and collect preliminary effectiveness data on a digital suicide prevention intervention that can be delivered in pediatric primary care settings by front line pediatricians. The study has the potential to offer a low-cost and scalable primary care intervention that may decrease risk of suicide among at-risk youth.

Detailed description: The study proposed is a treatment development study to enhance the capacity of pediatric primary care (PPC) to identify and manage suicidal youth by adapting iCHART for PPC settings that lack onsite behavioral health (BH) providers.

Stepped Wedge Cluster Randomized Pilot Trial: Conduct a stepped wedge cluster randomized pilot trial of iCHART-cASAP vs. usual care across 4 PROS practices (across urban, suburban, and rural settings). Up to 20 providers (up to 5 providers per practice) will be enrolled. Following a 3-month baseline period when all practices provide usual care, practices will be randomized to onset to offering the intervention at one of the four, 3-month intervention onset intervals. Each practice will enroll a total of 15 youth across the 15-month pilot trial period for a total of 60 youth. 30 youth will receive usual care and 30 youth will receive iCHART-cASAP.

Delivery of Intervention Intervention will be delivered to adolescent patients and their caregivers receiving services at pediatric primary care practices within the PROS network.When PPC providers are assigned to the usual condition, patients will receive usual practices following identification of suicide risk on the PHQ-9-M. When PPC providers have crossed over to the iCHART- cASAP intervention condition, patients who are identified as suicidal will receive links from PPC providers/office staff to complete cASAP + onboard BRITE app to receive the safety planning and skills training intervention for adolescent and parent/caregiver. Once that is completed, PPC providers receive a summary report and review the safety plan with the patient and parent/caregiver, making revisions as needed. The provider then reviews treatment plan, including behavioral health referrals and schedules follow-up appointment. Next, the PPC provider/office staff enters referral recommendations and follow-up appointment reminders into iCHART's Text2Connect feature, which will increase engagement with the safety plan and facilitate adherence with treatment recommendations.

Providers will approach patients and parents/caregivers about the research study during their office visit, and interested families will complete a permission to contact form for research staff. Research staff will contact and describe the study, answer any questions, and obtain parental consent/youth assent.

Sample Size and Power Considerations Once usability testing is complete, 60 participants will be recruited from 4 practices randomized to begin utilizing iCHART during one of the 3-month intervention intervals. At the end of the trial, 30 participants will be enrolled when practices were delivering usual care and 30 participants will be enrolled when practices were delivering iCHART- cASAP.

Sample size and power considerations center on the precision of confidence interval (CI) width estimation for feasibility outcomes. Based on best practices for feasibility studies, and given the sample size of 60 and 5% type I error rate, there is ability to estimate 95% confidence interval with margin-of-errors ≤0.33 for the primary outcomes of depression and suicidal thoughts and behaviors.

Eligibility criteria: Youth Inclusion:

* 12-17 years old
* Parent/legal guardian consents for youth to be in study
* English fluency and literacy-own a smart phone or device
* PHQ-9M score indicating moderate or severe depression or suicidal ideation in past month, past 2 weeks, or an attempt in their lifetime

Caregiver/Parent inclusion:

-English fluency and literacy

Youth Exclusion:

* evidence of intellectual delay
* pervasive developmental disorder
* other condition from medical history that would prohibit comprehension of questions or modules

Primary outcomes:
measure: Suicidal ideation and behavior on PHQ-9M
timeFrame: Baseline
measure: Suicidal ideation and behavior on PHQ-9M
timeFrame: 1-month follow-up
measure: Suicidal ideation and behavior on PHQ-9M
timeFrame: 3-month follow-up
measure: Suicidal ideation and behavior on PHQ-9M
timeFrame: 6-month follow-up
measure: Suicidal ideation and behavior on CSSRS
timeFrame: Baseline
measure: Suicidal ideation and behavior on CSSRS
timeFrame: 1-month follow-up
measure: Suicidal ideation and behavior on CSSRS
timeFrame: 3-month follow-up
measure: Suicidal ideation and behavior on CSSRS
timeFrame: 6-month follow-up
measure: Depression Severity
timeFrame: Baseline
measure: Depression Severity
timeFrame: 1-month follow-up
measure: Depression Severity
timeFrame: 3-month follow-up
measure: Depression Severity
timeFrame: 6-month follow-up
measure: Application utilization
timeFrame: Monitored over 6 months
measure: Service Utilization - SACA
timeFrame: Baseline
measure: Service Utilization - SACA
timeFrame: 6-month follow-up
measure: Patient Satisfaction
timeFrame: 6-month follow-up
measure: Acceptability
timeFrame: 6-month follow-up
measure: Patient Usability
timeFrame: 6-month follow-up
measure: Provider Feasibility of Intervention Measure
timeFrame: 6-month follow-up
measure: Provider Usability
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Stress
timeFrame: Baseline
measure: Stress
timeFrame: 1-month follow-up
measure: Stress
timeFrame: 3-month follow-up
measure: Stress
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Itasca
country: United States
facility: Pediatric Research in Office Settings National Headquarters
state: Illinois
Study officials:
affiliation: University of Pittsburgh
name: Stephanie Stepp
role: PRINCIPAL_INVESTIGATOR
References: