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Can a customized talk therapy lift depression in autistic teens?

NCT ID NCT07755137

Symptom relief Sponsor: Children's Hospital Los Angeles Source: ClinicalTrials.gov ↗

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 This study
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is testing whether a specially adapted form of cognitive behavioral therapy, called CBT-DAY, can reduce depressive symptoms in autistic youth aged 11 to 17. Participants will be randomly assigned to receive either CBT-DAY or standard care, and researchers will compare changes in depression severity, anxiety, and emotional coping over several months. The goal is to see if this tailored approach is both practical and effective in real-world clinical settings.

What this could mean

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

Active substance
Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY), a 12-week autism-adapted therapy
What this could lead to
If effective, this therapy could offer a practical, non-drug option to reduce depression in autistic teens, improving their emotional well-being and daily functioning.
What could go wrong
This is an early feasibility study, so results may not be conclusive. The therapy requires verbal ability and may not work for all autistic youth, and benefits may not last beyond the follow-up period.

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 140 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

11 to 17 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: Autistic youth: * Age 11 to 17 years * Prior clinical diagnosis of autism (per record review) * At least a fifth grade reading level * An ability to engage in sessions verbally (i.e., full length sentences) * Elevated symptoms of depression at baseline (RCADS) * Depression is a current clinical concern and participant is appropriate for intervention (per investigator determination) * At least one parent/caregiver willing and able to participate * Eligible to receive services at CHLA * If taking psychotropic medication, regimen must be stable for at least 8 weeks prior to baseline Parents/Caregivers: * Age 18 years or older * Parent or legal guardian of participating youth * Able to provide informed consent * Comfortable reading, writing, or speaking English or Spanish * Willing to participate in study procedures Exclusion Criteria: Autistic youth: * Lifetime diagnosis of bipolar disorder, psychotic disorder, or intellectual disability * Severe suicidal or homicidal ideation or self-injury requiring immediate higher-level care * Currently receiving psychotherapy for depression * Changes in psychotropic medication regimen during study participation (participants may be withdrawn) * A reading level below fifth-grade * An inability to engage in sessions verbally (i.e., nonverbal, minimally verbal) Parents/Caregivers: * Not the parent or legal guardian of the participating youth * Unable to provide informed consent * Not comfortable reading, writing, or speaking English or Spanish * Unwilling to participate in study procedures

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Conditions

The condition(s) this trial relates to.

anxiety disorder autism autism spectrum disorder Depression depressive disorder

As listed by the trial registrant

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

Anxiety disorders Autism spectrum disorder Depressive disorder

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.