Clinical trial NCT06273982: Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth
Official title: Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth: A Randomized Effectiveness-implementation Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: OCHIN, Inc.
name: National Institute of Mental Health (NIMH)
First posted: 2024-02-23
Enrollment: 220
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32)
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: 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.
measure: Children's Depression Rating Scale -- Revised (CDRS-R)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: San Diego State University
name: V. Robin Weersing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Frances Lynch, PhD
role: PRINCIPAL_INVESTIGATOR
References: