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

NCT06273982 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kaiser Permanente

    collaborator OTHER

  • OCHIN, Inc.

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • San Diego State University

    lead OTHER

Principal Investigators

  • V. Robin Weersing, PhD · San Diego State University

  • Frances Lynch, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06273982 on ClinicalTrials.gov