Optimizing Suicide Prevention Strategies for Pediatric Primary Care
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedStudy Start
First participant enrolled
June 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
July 3, 2025
July 1, 2025
11 months
November 30, 2023
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
Suicidal ideation and behavior on PHQ-9M
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.
Baseline
Suicidal ideation and behavior on PHQ-9M
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.
1-month follow-up
Suicidal ideation and behavior on PHQ-9M
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-month follow-up
Suicidal ideation and behavior on PHQ-9M
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.
6-month follow-up
Suicidal ideation and behavior on CSSRS
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.
Baseline
Suicidal ideation and behavior on CSSRS
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.
1-month follow-up
Suicidal ideation and behavior on CSSRS
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.
3-month follow-up
Suicidal ideation and behavior on CSSRS
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-month follow-up
Depression Severity
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'.
Baseline
Depression Severity
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'.
1-month follow-up
Depression Severity
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'.
3-month follow-up
Depression Severity
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'.
6-month follow-up
Application utilization
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.
Monitored over 6 months
Service Utilization - SACA
Frequency and type of behavioral/mental health and primary care services using the Service Assessment for Children and Adolescents (SACA).
Baseline
Service Utilization - SACA
Frequency and type of behavioral/mental health and primary care services using the Service Assessment for Children and Adolescents (SACA).
6-month follow-up
Patient Satisfaction
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
6-month follow-up
Acceptability
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'
6-month follow-up
Patient Usability
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'.
6-month follow-up
Provider Feasibility of Intervention Measure
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'.
6-month follow-up
Provider Usability
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'.
6-month follow-up
Secondary Outcomes (4)
Stress
Baseline
Stress
1-month follow-up
Stress
3-month follow-up
Stress
6-month follow-up
Study Arms (2)
iCHART/cASAP
EXPERIMENTALAn intervention previously studied in the ETUDES Center along with a computerized version of our As Safe As Possible intervention. 1. Safety Planning App for suicidal youth which enables a primary care provider to streamline the gold standard of care for those with current suicidality symptoms through an app; 2. Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement to help a primary care provider make a personalized, tailored treatment plan a suicidal youth is more likely to adhere to; 3. Text Messages which aims to provide texts for 2-3 weeks to motivate you to engage with the safety plan and recommended treatment following the patient visit. 4. cASAP is a computerized version of the As Safe As Possible intervention that offers self-led modules with psychoeducation about safety planning, cognitive-behavioral skills to cope with distress, and facilitate collaboration with parents.
Treatment as usual
ACTIVE COMPARATORWhen 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- English fluency and literacy
You may not qualify if:
- evidence of intellectual delay
- pervasive developmental disorder
- other condition from medical history that would prohibit comprehension of questions or modules
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Pediatric Research in Office Settingscollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Pediatric Research in Office Settings National Headquarters
Itasca, Illinois, 60143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Stepp
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The assessor and the investigator will be blinded to whether or not the participant received the iCHART/cASAP intervention or if they are receiving treatment as usual.
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 30, 2023
First Posted
January 8, 2024
Study Start
June 22, 2025
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
July 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study staff will work to create unique identifiers for all participants, create a data dictionary for all variables, and submit raw data bi-annually. Data will be released to NDCT after manuscripts reporting primary findings are accepted for publication.
- Access Criteria
- In addition to public access to the NDCT, data can be accessed by contacting study investigators.
Consistent with the NIMH's data sharing and data use policies this research study and clinical trial will be compliant with requirements for depositing data with the NIMH Data Archive (NDA) in the National Database for Clinical Trials Related to Mental Illness (NDCT). Specific statements will be added to the consent forms to allow for data sharing. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies.