Kaiser Permanente Center for Health Research
Portland, Oregon, 97227, United States
NCT Number: NCT06273982
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.
Interested in participating?
Request Info8 year–16 year
All sexes
Interventional
Not applicable
Portland, Oregon, 97227, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Brief Behavioral Therapy (BBT) for pediatric anxiety and depression
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.
Time frame: Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32)
Interviewer-rated youth functioning. Scores range from 1 to 100, and higher score indcate superior functioning.
Time frame: 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.
Interviewer-rated symptoms of anxiety disorders, combining parent and youth report
Time frame: 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.
Interviewer rated symptoms of depressive disorders, combining parent and youth report
San Diego State University
Other
Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth: A Randomized Effectiveness-implementation Study
Acronym: STEP-UP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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