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Can a brief online therapy ease anxiety and depression in kids? new study aims to find out.

NCT ID NCT06273982

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a brief behavioral therapy program delivered via telehealth (STEP-UP) for children and teens aged 8 to 16 with anxiety or depression. Participants are recruited from community health centers and randomly assigned to either STEP-UP or a referral to local mental health services. Researchers will check how youth are functioning and feeling before treatment, at 16 weeks, and at 24 weeks to see if STEP-UP improves daily life and reduces symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
STEP-UP (brief behavioral therapy) or assisted referral to community care
What this could lead to
If it works, this could provide an effective, accessible therapy option for youth with anxiety and depression in underserved communities.
What could go wrong
This is a relatively small trial (220 participants) testing a behavioral intervention, so results may not apply broadly. The therapy may not outperform standard referrals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227, United States

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