Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth (STEP-UP)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression, Anxiety
• Intervention / Treatment: Behavioral: STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression); Behavioral: ARC (assisted referral to community care)

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEP-UP	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.; Other Names: Brief Behavioral Therapy (BBT) for pediatric anxiety and depression
Active Comparator: ARC	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Global Assessment Scale (CGAS)	Interviewer-rated youth functioning. Scores range from 1 to 100, and higher score indcate superior functioning.	Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32)
Pediatric Anxiety Rating Scale (PARS)	Interviewer-rated symptoms of anxiety disorders, combining parent and youth report	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)	Interviewer rated symptoms of depressive disorders, combining parent and youth report	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.

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: National Institute of Mental Health (NIMH); Kaiser Permanente; OCHIN, Inc.
• Investigators: Principal Investigator: V. Robin Weersing, PhD, San Diego State University; Principal Investigator: Frances Lynch, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: HS-2023-0281-SMT; 1R01MH131698 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No