Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth

Official title

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

Overview

The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective.

Interventions

• Behavioral STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression)
  STEP-UP consists of 8 to 12 sessions of behavioral therapy for anxiety and / or depression. Skills taught include relaxation, problem solving, and exposure / behavioral activation.
• Behavioral ARC (assisted referral to community care)
  ARC consists of referral to community mental health treatment-as-usual. Families are provided psychoeducation about anxiety and depression and the benefits of treatment, lists of local community providers, and a problem-solving discussion about obstacles to obtaining care.

Primary outcome measures

• Children's Global Assessment Scale (CGAS) [Time frame: Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32)]
• Pediatric Anxiety Rating Scale (PARS) [Time frame: Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32). The PARS total severity score ranges from 0 to 30, with higher scores indicating greater anxiety severity.]
• Children's Depression Rating Scale -- Revised (CDRS-R) [Time frame: Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32). The CDRS-R total severity score ranges from 17 to 113, with higher scores indicating greater depression symptom severity.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Kaiser Permanente Center for Health Research — Portland

Publications

• Rodriguez F, Lynch FL, Gonzalez A, Rozenman M, Dickerson J, O'Keeffe-Rosetti M, Donald J, Hatch B, Barker G, Henninger M, Shaw M, Vaughn KA, Weersing VR. Behavioral telehealth in low-resource primary care settings for anxiety and depression in youth: protocol for a randomized effectiveness-implementation study. Trials. 2026 Jun 3. doi: 10.1186/s13063-026-09589-4. Online ahead of print. PMID 42237407

Identifiers

NCT: NCT06273982 · HS-2023-0281-SMT · 1R01MH131698

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗