Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention

Summary

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.

Conditions

• Suicide and Depression
• Adolescent Behavior

Interventions

BEHAVIORAL

iCHART

The 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.

BEHAVIORAL

Treatment As Usual

Participants 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• University of Oregon

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Stephanie Stepp, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-26

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• United States

Study Locations