Autism Spectrum DisorderCBT-DAYNCT07755137
Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings
A study testing CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) and Treatment-as-Usual (TAU) in people with Autism Spectrum Disorder and Depressive Disorder, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) can improve depressive symptoms and related mechanisms in autistic youth aged 11-17 years with depression receiving care in outpatient clinical settings. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Depressive Disorder, Anxiety Disorders
- What is being tested?
- CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) and Treatment-as-Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2029
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
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
Children's Hospital Los Angeles
Los Angeles, California, 90027
Jessica Schwartzman, PhD, 323-207-5910, trendlab@chla.usc.edu
Jessica Schwartzman, PhD
About this study
The goal of this clinical trial is to learn if Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) can improve depressive symptoms and related mechanisms in autistic youth aged 11-17 years with depression receiving care in outpatient clinical settings.
The main questions it aims to answer are:
Read more
- Does CBT-DAY lead to greater reductions in depressive symptom severity compared to treatment-as-usual (TAU)?
- Does CBT-DAY improve key mechanisms (emotional reactivity, self-esteem, and autism self-knowledge) associated with depression outcomes?
Researchers will compare CBT-DAY versus treatment-as-usual (TAU) to see if CBT-DAY results in greater improvements in depressive symptoms and related outcomes.
Participants will:
- Complete baseline, mid-treatment, post-treatment, and 3-month follow-up assessments (surveys and interviews)
- Be randomly assigned to receive either 12 weeks of CBT-DAY or treatment-as-usual
- Participate in therapy sessions during the 12-week intervention period
- Complete follow-up assessments three months after treatment to evaluate longer-term outcomes
- Being tested
- CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth), Treatment-as-Usual (TAU)
- Keywords
- depression, autism, youth, anxiety, cognitive behavioral therapy
- Medical subject headings
- Autism Spectrum Disorder, Depressive Disorder, Anxiety Disorders, Depression, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)Behavioural
CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) is a 12-week, autism-adapted cognitive behavioral therapy designed for verbally fluent autistic youth aged 11-17 to reduce depressive symptoms.
The intervention targets key mechanisms-emotional reactivity, negative self-esteem, and autism self-knowledge-using developmentally tailored CBT strategies appropriate for autistic individuals.
Treatment-as-Usual (TAU)Behavioural
Treatment-as-Usual (TAU) consists of standard clinical care delivered by clinicians with limited autism training in the same outpatient setting.
It typically involves supportive, talk-based psychotherapy without the structured, autism-adapted components of CBT-DAY.
| Study group | Role | What they receive |
|---|---|---|
| CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) | Experimental | Participants receive a structured, 12-week Cognitive Behavioral Therapy program adapted for autistic youth, targeting depressive symptoms and underlying mechanisms such as emotional reactivity and self-esteem.
Therapy is delivered by trained clinicians with weekly sessions and includes assessments at baseline, mid-treatment, post-treatment, and follow-up. Receives: Behavioral: CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) |
| Treatment-as-Usual (TAU) | Active comparator | Participants receive standard outpatient mental health care, typically consisting of supportive, talk-based therapy provided by clinicians without CBT-DAY training.
Participants complete the same assessment schedule as the experimental arm across baseline, treatment, and follow-up timepoints. Receives: Behavioral: Treatment-as-Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptom severity
Change in depressive symptom severity as assessed by the Modified Depression Module of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). This is a semi-structured clinical interview evaluating DSM-5 depressive symptoms over the previous 2 weeks. Each symptom is rated on a 6-point scale (1 = not present to 6 = severe). Higher scores indicating greater symptom severity. The outcome will be evaluated as change in total depression severity scores over time and compared between CBT-DAY and TAU groups. The KSADS will be administered four times from baseline to 6 months.
Measured: Baseline to week 24
Secondary outcomes (6)
Change in Anxiety Symptoms
Change in anxiety symptom severity as assessed by the Pediatric Anxiety Rating Scale adapted for Autism Spectrum Disorder (PARS-ASD). This is a semi-structured clinical interview assessing type and severity of anxiety symptoms. Each symptom is rated on a 6 point scale (0 = never to 5 = always). Higher scores indicate greater severity of anxiety symptoms. The outcome will be evaluated as change in anxiety scores over time and compared between CBT DAY and TAU groups. The PARS-ASD will be administered four times from baseline to 6 months.
Measured: Baseline to week 24
Change in Suicidal Ideation
Change in severity of suicidal ideation measured by the Suicidal Ideation Questionnaire-Junior (SIQ-Jr). This is a youth-report survey evaluating dfrequency of suicidal thoughts over the previous 2 weeks. Items are rated on a 7-point scale (0 = never to 6 = almost every day), with higher total scores indicating more severe suicidal ideation. The outcome will be evaluated as change in suicidal ideation scores over time and compared between CBT DAY and TAU groups. The SIQ-Jr will be administered four times from baseline to 6 months.
Measured: Baseline to week 24
Change in Life Satisfaction
Change in youth-reported life satisfaction measured using the PROMIS Pediatric Short Form - Life Satisfaction. This is a youth-report survey evaluating satisfaction with life over the past month. Items are rated on a 5-point scale, with higher scores indicating greater life satisfaction. The outcome will be evaluated as change in life satisfaction over time and compared between CBT DAY and TAU groups. The PROMIS will be administered four times from baseline to 6 months.
Measured: Baseline to week 24
Change in Emotional Reactivity
Change in emotional reactivity as assessed by the Emotion Dysregulation Inventory (EDI). This is a youth- and parent-report survey evaluating emotion dysregulation in youth. Each symptom is rated on a 5-point scale (0 = not at all to 4 = very severe). Higher scores indicate greater emotion dysregulation. The outcome will be evaluated as change in emotional dysregulation over time and compared between CBT DAY and TAU groups. The EDI will be administered four times from baseline to 6 months.
Measured: Baseline to week 24
Change in Self-Esteem
Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale (RSES). This is a youth-report survey evaluating self-esteem. Each item is rated on a 4-point scale (1 = strongly disagree to 4 = strongly agree). Higher scores indicate higher self-esteem. The outcome will be evaluated as change in self-esteem scores over time and compared between CBT DAY and TAU groups. The RSES will be administered four times from baseline to 6 months.
Measured: Baseline to week 24
Change in Autism Self-Knowledge
Change in autism self-knowledge as assessed by the Autism Personal and Community Identity (APCI) scale. This is a youth-report survey evaluating autism self-knowledge. Each item is rated on a 6-point scale (1 = strong disagree to 6 = strongly agree). Higher scores indicate higher autism self-knowledge. The outcome will be evaluated as change in autism self-knowledge over time and compared between CBT DAY and TAU groups. The APCI will be administered four times from baseline to 6 months.
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Model description
- Autistic youth will be randomized 1:1 to receive 12 weeks of Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) or treatment-as-usual (TAU).
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica Schwartzman, Children's Hospital Los Angeles
- Investigators
- Jessica Schwartzman, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755137
- Sponsor's protocol ID
- CHLA-25-00214
- Other IDs
- 1R34MH140993-01
- Acronym
- CBT-DAY
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings
- ClinicalTrials.gov ID
- NCT07755137
- Acronym / sponsor ID
- CBT-DAY / CHLA-25-00214
- Keywords
- depression, autism, youth, anxiety, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 10 Aug 2026 (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 learn if Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) can improve depressive symptoms and related mechanisms in autistic youth aged 11-17 years with depression receiving care in outpatient clinical settings.
The main questions it aims to answer are:
- Does CBT-DAY lead to greater reductions in depressive symptom severity compared to treatment-as-usual (TAU)?
- Does CBT-DAY improve key mechanisms (emotional reactivity, self-esteem, and autism self-knowledge) associated with depression outcomes?
Researchers will compare CBT-DAY versus treatment-as-usual (TAU) to see if CBT-DAY results in greater improvements in depressive symptoms and related outcomes.
Participants will:
- Complete baseline, mid-treatment, post-treatment, and 3-month follow-up assessments (surveys and interviews)
- Be randomly assigned to receive either 12 weeks of CBT-DAY or treatment-as-usual
- Participate in therapy sessions during the 12-week intervention period
- Complete follow-up assessments three months after treatment to evaluate longer-term outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Autistic youth will be randomized 1:1 to receive 12 weeks of Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) or treatment-as-usual (TAU).
| Arm | Type | Receives |
|---|---|---|
| CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) | Experimental | Behavioral: CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)Participants receive a structured, 12-week Cognitive Behavioral Therapy program adapted for autistic youth, targeting depressive symptoms and underlying mechanisms such as emotional reactivity and self-esteem. Therapy is delivered by trained clinicians with weekly sessions and includes assessments at baseline, mid-treatment, post-treatment, and follow-up. |
| Treatment-as-Usual (TAU) | Active comparator | Behavioral: Treatment-as-Usual (TAU)Participants receive standard outpatient mental health care, typically consisting of supportive, talk-based therapy provided by clinicians without CBT-DAY training. Participants complete the same assessment schedule as the experimental arm across baseline, treatment, and follow-up timepoints. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) is a 12-week, autism-adapted cognitive behavioral therapy designed for verbally fluent autistic youth aged 11-17 to reduce depressive symptoms. The intervention targets key mechanisms-emotional reactivity, negative self-esteem, and autism self-knowledge-using developmentally tailored CBT strategies appropriate for autistic individuals. | Behavioural | CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) |
| Treatment-as-Usual (TAU)Treatment-as-Usual (TAU) consists of standard clinical care delivered by clinicians with limited autism training in the same outpatient setting. It typically involves supportive, talk-based psychotherapy without the structured, autism-adapted components of CBT-DAY. | Behavioural | Treatment-as-Usual (TAU) |
Primary outcome
Change in depressive symptom severity
Time frame: Baseline to week 24
Change in depressive symptom severity as assessed by the Modified Depression Module of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). This is a semi-structured clinical interview evaluating DSM-5 depressive symptoms over the previous 2 weeks. Each symptom is rated on a 6-point scale (1 = not present to 6 = severe). Higher scores indicating greater symptom severity. The outcome will be evaluated as change in total depression severity scores over time and compared between CBT-DAY and TAU groups. The KSADS will be administered four times from baseline to 6 months.
6 secondary outcomes
Change in Anxiety Symptoms
Time frame: Baseline to week 24
Change in Suicidal Ideation
Time frame: Baseline to week 24
Change in Life Satisfaction
Time frame: Baseline to week 24
Change in Emotional Reactivity
Time frame: Baseline to week 24
Change in Self-Esteem
Time frame: Baseline to week 24
Change in Autism Self-Knowledge
Time frame: Baseline to week 24
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jessica Schwartzman, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) and Treatment-as-Usual (TAU) in people with Autism Spectrum Disorder and Depressive Disorder, run by Children's Hospital Los Angeles 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 16 inclusion and 12 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: opening soon, as of the sponsor's last update on 10 Aug 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?
Contact Jessica Schwartzman, PhD (323-207-5910, trendlab@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptom severity (time frame: Baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.