Adolescent Behavior Clinical Trial
Official title:
The Center for Enhancing Triage and Utilization for Depression and Emergent Suicidality (ETUDES) in Pediatric Primary Care-iCHART RCT
This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cybervictimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicidal-related events by 50%, and the effects will be mediated by increases in referrals, treatment engagement, and safety planning. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | April 30, 2027 |
Est. primary completion date | April 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - YOUTH - Youth will be age 12-18 and speak English. - Youth will have current depression or suicidal behavior. Suicidal behavior for iCHART (N=900) is defined as past suicidal thoughts in the past two weeks as indicated by PHQ-9M item #9 = 1, and/or past month suicidal thoughts, and/or prior history of attempt as indicated by items on the PHQ-9M; and 300 who screen positive for depression (PHQ-9M = "11") - 50% of the 300 youth with PHQ-9M = "11" will also be positive for suicide risk as defined for iCHART. - CAREGIVERS/PARENTS - Parents/caregivers of youth in the study must be at least 18 years old and their child must be willing to participate in the study. Caregivers/parents must be able to speak English. Parents are considered biological/adoptive parents or have court documentation that they can provide consent for research as a legal guardian of a youth. Only 1 parent/caregiver will be engaged in research, but in case 1 parent is unavailable, the other may be engaged (meaning it doesn't have to be the same parent participating in assessments/interviews throughout youth study participation). Exclusion Criteria: - YOUTH - Exclusion criteria include conditions that might impair their ability to effectively deploy ETUDES interventions, including: - current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure. The latter will will be assessed by parental report of placement in self-contained Special Education classes, EHR review, and during the consent/assent and/or baseline to determine if the participant is not understanding research procedures. - Participants without access to a phone and/or tablet to interact with components of the intervention that require a phone will be excluded. - CAREGIVERS/PARENTS - There are no specific exclusion criteria for caregivers and providers. However, as mentioned in the inclusion criteria, caregivers will be excluded if they are not the biological parent or court-appointed guardian of the youth being interviewed. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC | McMurray | Pennsylvania |
United States | CHOP Primary Care, CHOP Campus | Philadelphia | Pennsylvania |
United States | CHOP Primary Care, Cobbs Creek | Philadelphia | Pennsylvania |
United States | UPMC Center for Adolescent and Young Adult Health | Pittsburgh | Pennsylvania |
United States | CHOP Primary Care, West Chester | West Chester | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Children's Hospital of Philadelphia, Columbia University, Kaiser Permanente, National Institute of Mental Health (NIMH), University of Oregon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression Severity | Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity. Total Score Depression Severity: 0-4 No or Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. | Baseline | |
Primary | Depression Severity | Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity. Total Score Depression Severity: 0-4 No or Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. | 1 Month Follow Up | |
Primary | Depression Severity | Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity. Total Score Depression Severity: 0-4 No or Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. | 3 Month Follow Up | |
Primary | Depression Severity | Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity. Total Score Depression Severity: 0-4 No or Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. | 6 Month Follow Up | |
Primary | Depression Severity | Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity. Total Score Depression Severity: 0-4 No or Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. | 12 Month Follow Up | |
Primary | Suicidal Ideation and Behavior | Suicidal attempt and ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). The following outcomes are C-SSRS categories: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; Preparatory Acts or Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide.
Self-injurious behavior without suicidal intent is also a C-SSRS outcome and has a binary response (yes/no). Suicidal Ideation Score is a numerical score derived from the C-SSRS categories. The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. Assign a score of 0 if no ideation is present. |
Baseline | |
Primary | Suicidal Ideation and Behavior | Suicidal attempt and ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). The following outcomes are C-SSRS categories: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; Preparatory Acts or Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide.
Self-injurious behavior without suicidal intent is also a C-SSRS outcome and has a binary response (yes/no). Suicidal Ideation Score is a numerical score derived from the C-SSRS categories. The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. Assign a score of 0 if no ideation is present. |
1 month follow up | |
Primary | Suicidal Ideation and Behavior | Suicidal attempt and ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). The following outcomes are C-SSRS categories: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; Preparatory Acts or Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide.
Self-injurious behavior without suicidal intent is also a C-SSRS outcome and has a binary response (yes/no). Suicidal Ideation Score is a numerical score derived from the C-SSRS categories. The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. Assign a score of 0 if no ideation is present. |
3 month follow up | |
Primary | Suicidal Ideation and Behavior | Suicidal attempt and ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). The following outcomes are C-SSRS categories: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; Preparatory Acts or Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide.
Self-injurious behavior without suicidal intent is also a C-SSRS outcome and has a binary response (yes/no). Suicidal Ideation Score is a numerical score derived from the C-SSRS categories. The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. Assign a score of 0 if no ideation is present. |
6 month follow up | |
Primary | Suicidal Ideation and Behavior | Suicidal attempt and ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). The following outcomes are C-SSRS categories: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; Preparatory Acts or Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide.
Self-injurious behavior without suicidal intent is also a C-SSRS outcome and has a binary response (yes/no). Suicidal Ideation Score is a numerical score derived from the C-SSRS categories. The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. Assign a score of 0 if no ideation is present. |
12 month follow up | |
Secondary | Service Utilization | Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only). | Baseline | |
Secondary | Service Utilization | Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only). | 6 month follow up | |
Secondary | Service Utilization | Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only). | 12 month follow up | |
Secondary | Application Utilization | Use of the technical components of interventions and web portals of iCHART including: the number and proportion of adolescents, parents, and providers who have engaged with the application over time | Post-intervention-6 month follow up | |
Secondary | Intervention Acceptability (intervention liked by study population) | Acceptability of the iCHART intervention will be assessed through the 4 item Acceptability of Intervention Measure (AIM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater acceptability. The items include questions to determine if intervention is appealing to, liked by, welcomed by, and approved by study population. | Post-intervention-6 month follow up | |
Secondary | Intervention Usability | Usability of the iCHART intervention will be assessed through the Post System Satisfaction Usability Questionnaire (PSSUQ). PSSUQ follows a 7-point Likert Scale (+ NA option). The overall result is calculated by averaging the scores from the 7 points of the scale. It also has 3 sub-scales, namely system usefulness, information quality, and interface quality. The sub-scales provide a more detailed breakdown of different factors affecting the intervention. PSSUQ score starts with 1 (strongly agree) and ends with 7 (strongly disagree). The lower the score, the better the performance and satisfaction. | Post-intervention-6 month follow up | |
Secondary | Intervention Feasibility (intervention is implementable in study population) | Feasibility of the iCHART intervention will be assessed through the 4 item Feasibility of Intervention Measure (FIM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater feasibility. The items include questions to determine if intervention is easy to use and seems possible or doable to implement in study population. | Post-intervention-6 month follow up | |
Secondary | Intervention Appropriateness (intervention fits or matches study population needs) | Intervention appropriateness of the iCHART intervention will be assessed through 4 item Intervention Appropriateness Measure (IAM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater appropriateness. The items include questions to determine if intervention is a good match, fitting, suitable, or seems applicable to the study population. | Post-intervention-6 month follow up |
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