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

NCT06273982 | Enrolling By Invitation DMC

• 2 other identifiers: HS-2023-0281-SMT1R01MH131698
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

STEP-UP

EXPERIMENTAL

Behavioral: STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression)

ARC

ACTIVE COMPARATOR

Behavioral: ARC (assisted referral to community care)

Interventions

STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) BEHAVIORAL

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.

Also known as: Brief Behavioral Therapy (BBT) for pediatric anxiety and depression

STEP-UP

ARC (assisted referral to community care) BEHAVIORAL

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.

ARC

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego State University: lead
• Kaiser Permanente: collaborator
• OCHIN, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• V. Robin Weersing, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Frances Lynch, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)