NCT06273982

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: San Diego State University · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-09
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2024-02-23
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States