Depression Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Pediatric Research in Office Settings National Headquarters | Itasca | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute of Mental Health (NIMH), Pediatric Research in Office Settings |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Service Utilization - SACA | Frequency and type of behavioral/mental health and primary care services using the Service Assessment for Children and Adolescents (SACA). | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Stress | 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'. | Baseline | |
Secondary | Stress | 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'. | 1-month follow-up | |
Secondary | Stress | 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-month follow-up | |
Secondary | Stress | 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'. | 6-month follow-up |
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