Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
YOUTH
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
Trial design
Design model
Parallel
Treatments tested in this trial
iCHART
BehavioralThe Safety Planning App will guide primary care providers or mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt. The Mental Health Screener is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. The Text Messages is a personalized text messaging intervention for patients and parents that targets engagement with the safety plan to increase the likelihood that a depressed or suicidal patient will maintain or initiate recommended services. Participants will receive usual care at their pediatric primary care practice following screening including information, psychoeducation, and referral to a mental health treatment provider.
Treatment As Usual
BehavioralParticipants in this group will receive usual care from their primary care provider or mental health care provider which may include development of a paper safety plan.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: iCHARTExperimental treatment 1 intervention
Group B: Treatment As Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
1 Month Follow Up3
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.
Time frame
3 Month Follow Up4
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.
Time frame
6 Month Follow UpSecondary outcomes
1
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).
Time frame
Baseline2
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).
Time frame
6 month follow up3
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).
Time frame
12 month follow up4
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
Time frame
Post-intervention-6 month follow upSponsors and contacts
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University of Pittsburgh
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
University of Oregon
Collaborator
Columbia University
Collaborator
Kaiser Permanente
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov