UnknownNANCT06273982

Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth: A Randomized Effectiveness-implementation Study

Sponsor: San Diego State University

Trial Details

ConditionDepression, Anxiety
InterventionSTEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression); ARC (assisted referral to community care)
PhaseNA
StatusUnknown
Participants220
Est. Completion31 May 2028
Last Updated13 Apr 2026

Primary Outcome

Children's Global Assessment Scale (CGAS); Pediatric Anxiety Rating Scale (PARS); Children's Depression Rating Scale -- Revised (CDRS-R)

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * Youth is a patient in a participating community health center. * Youths meet criteria for clinically significant anxiety and / or depression as indexed at baseline assessment by either: * research diagnosis of anxiety (Social Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder) and / or depressive disorder (Major Depressive Disorder, Persistent Depressive Disorder). * scores in the clinically elevated range on a standardized anxiety and / or depression symptom measure . * Youth lives with a legal guardian (hereafter referred to as "parent") \>= 50% of the time who consents to study participation. * Youth speaks English. * Parent speaks English or Spanish. Exclusion Criteria: * Youth requires alternate treatment as indexed by: * current clinically significant Post-Traumatic Stress Disorder symptoms (meets diagnostic criteria in research interview and / or scores in the clinically elevated range on a standardized symptom measure) at baseline. * current suicidal ideation with plan at baseline and / or suicidal behavior within the last year. * current substance dependence at baseline. * experience of physical or sexual abuse within the six months prior to baseline. * parent /guardian does not identify anxiety and / or depression as a treatment priority at baseline. * Youth is in an active, alternate psychosocial intervention for anxiety or depression that would be concurrent with study participation. * Youth is on an unstable regimen of psychotropic medication (i.e., receives medication but has not been at a stable dose for at least 8 weeks, or if medication has been discontinued for less than 4 weeks) at baseline. * Youth is receiving lithium or and anti-psychotic medication at baseline. * Youth is placed in a special education program for greater than 50% of the school day and / or youth school placement is below the second-grade level at baseline. * Youth is placed in foster care at baseline.

Trial Sites

Countries

United States
View Registry Entry

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