A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.040 | 0.038 |
| Meta-epidemiology (narrow) | 0.007 | 0.004 |
| Meta-epidemiology (broad) | 0.014 | 0.007 |
| Bibliometrics | 0.004 | 0.005 |
| Science and technology studies | 0.005 | 0.004 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.008 | 0.012 |
| Insufficient payload (model declined to judge) | 0.118 | 0.016 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".