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OpenTrials
Completed

NCT Number: NCT06194331

Optimizing Suicide Prevention Strategies for Pediatric Primary Care

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.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Depression Self-Injurious Behavior Suicidal and Self-Injurious Behavior Suicide

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Research in Office Settings National Headquarters

Itasca, Illinois, 60143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCHART/cASAP

Behavioral

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.

Treatment as Usual

Behavioral

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.

Primary outcomes

  1. Suicidal ideation and behavior on PHQ-9M

    Time frame: Baseline

    Suicidal ideation and attempt will be measured by 3 items on the PHQ-9-M (item #9 with scaled options of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day', past month ideation, prior suicide attempt) as a primary outcome.

  2. Suicidal ideation and behavior on PHQ-9M

    Time frame: 1-month follow-up

    Suicidal ideation and attempt will be measured by 3 items on the PHQ-9-M (item #9 with scaled options of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day', past month ideation, prior suicide attempt) as a primary outcome.

  3. Suicidal ideation and behavior on PHQ-9M

    Time frame: 3-month follow-up

    Suicidal ideation and attempt will be measured by 3 items on the PHQ-9-M (item #9 with scaled options of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day', past month ideation, prior suicide attempt) as a primary outcome.

  4. Suicidal ideation and behavior on PHQ-9M

    Time frame: 6-month follow-up

    Suicidal ideation and attempt will be measured by 3 items on the PHQ-9-M (item #9 with scaled options of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day', past month ideation, prior suicide attempt) as a primary outcome.

  5. Suicidal ideation and behavior on CSSRS

    Time frame: Baseline

    Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.

  6. Suicidal ideation and behavior on CSSRS

    Time frame: 1-month follow-up

    Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.

  7. Suicidal ideation and behavior on CSSRS

    Time frame: 3-month follow-up

    Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.

  8. Suicidal ideation and behavior on CSSRS

    Time frame: 6-month follow-up

    Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.

  9. Depression Severity

    Time frame: Baseline

    Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity, as a primary outcome. The PHQ-9M uses scaled responses of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day'.

  10. Depression Severity

    Time frame: 1-month follow-up

    Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity, as a primary outcome. The PHQ-9M uses scaled responses of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day'.

  11. Depression Severity

    Time frame: 3-month follow-up

    Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity, as a primary outcome. The PHQ-9M uses scaled responses of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day'.

  12. Depression Severity

    Time frame: 6-month follow-up

    Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity, as a primary outcome. The PHQ-9M uses scaled responses of '0=not at all, 1=several days, 2=more than half the days, 3=nearly every day'.

  13. Application utilization

    Time frame: Monitored over 6 months

    Use of the iCHART-cASAP components and web portals will be monitored. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.

  14. Service Utilization - SACA

    Time frame: Baseline

    Frequency and type of behavioral/mental health and primary care services using the Service Assessment for Children and Adolescents (SACA).

  15. Service Utilization - SACA

    Time frame: 6-month follow-up

    Frequency and type of behavioral/mental health and primary care services using the Service Assessment for Children and Adolescents (SACA).

  16. Patient Satisfaction

    Time frame: 6-month follow-up

    Satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ). The scaled options for the CSQ vary as follows:

    Question 1: "4=Excellent, 3=Good, 2=Fair, 1=Poor" Question 2: "1=No, Definitely Not, 2=No, Not Really, 3=Yes, Generally, 4=Yes, Definitely" Question 3: "4=Almost all of my needs have been met, 3=Most of my needs have been met, 2=Only a few of my needs have been met, 1=None of my needs have been met" Question 4: "1=No, definitely not, 2=No, I don't think so, 3=Yes, I think so, 4=Yes, Definitely" Question 5: "1=Quite Dissatisfied, 2=Indifferent or mildly dissatisfied, 3=Mostly satisfied, 4=Very satisfied" Question 6: "4=Yes, they helped a great deal, 3=Yes, they helped somewhat, 2=No, they really didn't help, 1=No, they seemed to make things worse" Question 7: "4=Very satisfied, 3=Mostly satisfied, 2=Indifferent or mildly dissatisfied, 1=Quite dissatisfied" Question 8: "1=No, Definitely not, 2=No, I don't think so, 3=Yes, I think so, 4=Yes, Definitely

  17. Acceptability

    Time frame: 6-month follow-up

    Acceptability of cASAP and the iCHART-cASAP intervention will be assessed through the Acceptability of Intervention Measure (AIM). The scaled options for the measure are: '1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree'

  18. Patient Usability

    Time frame: 6-month follow-up

    Patient usability will be measured by the Systems Usability Survey (SUS). The System Usability Scale uses scaled options of: '1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree'.

  19. Provider Feasibility of Intervention Measure

    Time frame: 6-month follow-up

    Provider Feasibility will be measured using the Feasibility of Intervention Measure (FIM). The Feasibilty of Intervention Measure uses scaled options of: '1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree'.

  20. Provider Usability

    Time frame: 6-month follow-up

    System Usability Scale (SUS) will assess usability. The System Usability Scale uses scaled options of: '1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree'.

Secondary outcomes

  1. Stress

    Time frame: Baseline

    Stress will be measured by the Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences 4- item Short Form. The scaled options for this measure are: '1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always'.

  2. Stress

    Time frame: 1-month follow-up

    Stress will be measured by the Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences 4- item Short Form. The scaled options for this measure are: '1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always'.

  3. Stress

    Time frame: 3-month follow-up

    Stress will be measured by the Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences 4- item Short Form. The scaled options for this measure are: '1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always'.

  4. Stress

    Time frame: 6-month follow-up

    Stress will be measured by the Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences 4- item Short Form. The scaled options for this measure are: '1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always'.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Pediatric Research in Office Settings

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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