NCT06194331

Optimizing Suicide Prevention Strategies for Pediatric Primary Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suicidal Ideation
• Suicidal and Self-injurious Behavior
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	iCHART/cASAP	When patients disclose suicidal ideation on the PHQ-9, the intervention of iCHART/cASAP will be implemented in the pediatrician's office, and in collaboration with parents, which includes safety planning, teaching skills to improve distress tolerance and emotion regulation all on the teen's smart device. iCHART/cASAP will include: Screening Wizard, a digital screening tool that will guide the provider to gauge patient satisfaction with current treatment and making further personalized treatment recommendations; cASAP, a computerized version of the As Safe As Possible intervention that focuses on psychoeducation in safety planning, distress tolerance, and emotion regulation skills; BRITE, a safety planning app with distress monitoring that a teen can be guided through with automated onboarding manuals; Text2Connect, an automated text messaging sent centrally to patients and parents to enhance treatment adherence.
BEHAVIORAL	Treatment as usual	When patients disclose suicidal ideation on the PHQ-9, a treatment as usual approach will be given to the patient and their parent by the pediatrician which includes a paper safety plan will be completed and given to the patient and a referral placed for the patient to begin behavioral health services.

Timeline

• Start date: 2025-06-22
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2024-01-08
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States