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

Part of paid clinical trials in Portland, Oregon.

Sponsor
San Diego State University
Study ID
NCT06273982
Status
Enrolling By Invitation

Conditions

  • Depression, Anxiety

Eligibility Criteria

Sex
ALL
Age
8 Years - 16 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 9, 2024
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: STEP-UP
  • Active Comparator: ARC

Primary Outcome Measure

Children's Global Assessment Scale (CGAS) [ Time Frame: Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Center for Health ResearchPortlandOregon97227-

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By research site
Kaiser Permanente Center for Health Research· Portland, OR

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