Depression, AnxietySTEP-UPNCT06273982
Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth
A study testing STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) and ARC (assisted referral to community care) in people with Depression, Anxiety, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) and ARC (assisted referral to community care)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth: A Randomized Effectiveness-implementation Study
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
- Being tested
- STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression), ARC (assisted referral to community care)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression)Behavioural
Also called Brief Behavioral Therapy (BBT) 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.
ARC (assisted referral to community care)Behavioural
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 group | Role | What they receive |
|---|---|---|
| STEP-UP | Experimental | Not described Receives: Behavioral: STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) |
| ARC | Active comparator | Not described Receives: Behavioral: ARC (assisted referral to community care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Global Assessment Scale (CGAS)
Interviewer-rated youth functioning. Scores range from 1 to 100, and higher score indcate superior functioning.
Measured: Measured at baseline (Week 0) and follow-up assessments (Week 16 and Week 32)
Pediatric Anxiety Rating Scale (PARS)
Interviewer-rated symptoms of anxiety disorders, combining parent and youth report
Measured: 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.
Children's Depression Rating Scale -- Revised (CDRS-R)
Interviewer rated symptoms of depressive disorders, combining parent and youth report
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start9 Jul 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, OCHIN, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- V. Robin Weersing, PhD, Principal investigator, San Diego State UniversityFrances Lynch, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273982
- Sponsor's protocol ID
- HS-2023-0281-SMT
- Other IDs
- 1R01MH131698
- Acronym
- STEP-UP
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rodriguez F, Lynch FL, Gonzalez A, Rozenman M, Dickerson J, O'Keeffe-Rosetti M, Donald J, Hatch B, Barker G, Henninger M, Shaw M, Vaughn KA, Weersing VR. Behavioral telehealth in low-resource primary care settings for anxiety and depression in youth: protocol for a randomized effectiveness-implementation study. Trials. 2026 Jun 3. doi: 10.1186/s13063-026-09589-4. Online ahead of print.
PubMed 42237407
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth: A Randomized Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT06273982
- Acronym / sponsor ID
- STEP-UP / HS-2023-0281-SMT
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Kaiser Permanente, OCHIN, Inc., National Institute of Mental Health (NIMH)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEP-UP | Experimental | Behavioral: STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) |
| ARC | Active comparator | Behavioral: ARC (assisted referral to community care) |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- Youth requires alternate treatment as indexed by:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression)Also: Brief Behavioral Therapy (BBT) for pediatric anxiety and depressionSTEP-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. | Behavioural | STEP-UP |
| 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. | Behavioural | ARC |
Primary outcome
Children's Global Assessment Scale (CGAS)
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.
Pediatric Anxiety Rating Scale (PARS)
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
Children's Depression Rating Scale -- Revised (CDRS-R)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42237407Rodriguez F, Lynch FL, Gonzalez A, Rozenman M, Dickerson J, O'Keeffe-Rosetti M, Donald J, Hatch B, Barker G, Henninger M, Shaw M, Vaughn KA, Weersing VR. Behavioral telehealth in low-resource primary care settings for anxiety and depression in youth: protocol for a randomized effectiveness-implementation study. Trials. 2026 Jun 3. doi: 10.1186/s13063-026-09589-4. Online ahead of print.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
V. Robin Weersing, PhD principal investigator
San Diego State University
Frances Lynch, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) and ARC (assisted referral to community care) in people with Depression, Anxiety, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.