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

Qualifiers

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

Treatments tested in this trial

  • iCHART
  • Treatment As Usual

Treatment groups

900 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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