Background Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services. Objective This paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study’s secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group. Methods Participants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children’s hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. Results Recruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants. Conclusions Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field’s current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases. Trial Registration ClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913 International Registered Report Identifier (IRRID) DERR1-10.2196/44940

BACKGROUND Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youth and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile application, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other mental health support services. OBJECTIVE This manuscript describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youth presenting with depression and/or anxiety. The study’s secondary aim will compare clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and CBT-group. METHODS Participants include youth aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children’s hospital. Eligible youth will have no recent safety concerns or complex comorbid clinical diagnoses, have no concurrent individual therapy and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. RESULTS The protocol received Institutional Review Board (IRB) approval on 3/31/22 and recruitment began in May 2022. CONCLUSIONS Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field’s current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the non-inferiority of W-GenZD against CBT group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youth with lower intensity needs as well as possibly reduce wait lists and optimize clinician deployment toward more severe cases. CLINICALTRIAL ClinicalTrials.gov NCT05372913